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New Jersey, United States, Oct 17, 2022 /DigitalJournal/ The Enterprise Document Management Systems Market research report provides all the information related to the industry. It gives the markets outlook by giving authentic data to its client which helps to make essential decisions. It gives an overview of the market which includes its definition, applications and developments, and manufacturing technology. This Enterprise Document Management Systems market research report tracks all the recent developments and innovations in the market. It gives the data regarding the obstacles while establishing the business and guides to overcome the upcoming challenges and obstacles.
Enterprise Records Management (EDM) is a strategy for overseeing an organizations paper and electronic records so that they can be easily retrieved during a compliance audit or subpoena. The term originally referred to electronic documents created on a computer or paper documents scanned into a digital format. The meaning has expanded to include emails, images, internal documents such as company memos and external documents such as marketing or sales content.
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Competitive landscape:
This Enterprise Document Management Systems research report throws light on the major market players thriving in the market; it tracks their business strategies, financial status, and upcoming products.
Some of the Top companies Influencing this Market include:Ademero, Adobe Systems Incorporated, Ascensio System SIA, Blue Project Software, Box, Dropbox Business, eFileCabinet, Evernote Corporation, Google, Konica Minolta, LSSP, Lucion Technologies, M-Files, Microsoft Corporation, Nuance, Officegemini, Salesforce, Speedy Solutions, Zoho Corporation,
Market Scenario:
Firstly, this Enterprise Document Management Systems research report introduces the market by providing an overview that includes definitions, applications, product launches, developments, challenges, and regions. The market is forecasted to reveal strong development by driven consumption in various markets. An analysis of the current market designs and other basic characteristics is provided in the Enterprise Document Management Systems report.
Regional Coverage:
The region-wise coverage of the market is mentioned in the report, mainly focusing on the regions:
Segmentation Analysis of the market
The market is segmented based on the type, product, end users, raw materials, etc. the segmentation helps to deliver a precise explanation of the market
Market Segmentation: By Type
On-premise
Cloud-based
Market Segmentation: By Application
SMEs
Large Enterprises
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An assessment of the market attractiveness about the competition that new players and products are likely to present to older ones has been provided in the publication. The research report also mentions the innovations, new developments, marketing strategies, branding techniques, and products of the key participants in the global Enterprise Document Management Systems market. To present a clear vision of the market the competitive landscape has been thoroughly analyzed utilizing the value chain analysis. The opportunities and threats present in the future for the key market players have also been emphasized in the publication.
This report aims to provide:
Table of Contents
Global Enterprise Document Management Systems Market Research Report 2022 – 2029
Chapter 1 Enterprise Document Management Systems Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Production, Revenue (Value) by Region
Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions
Chapter 6 Global Production, Revenue (Value), Price Trend by Type
Chapter 7 Global Market Analysis by Application
Chapter 8 Manufacturing Cost Analysis
Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10 Marketing Strategy Analysis, Distributors/Traders
Chapter 11 Market Effect Factors Analysis
Chapter 12 Global Enterprise Document Management Systems Market Forecast
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COMTEX_416803509/2769/2022-10-17T08:02:30

While some of Slack’s private code repositories were breached, Slack’s primary codebase and customer data remain unaffected, according to the company.
Analysis of Google Trends data shows a clear spike in interest over the past month or so, coinciding with the app’s release, both in…
United Airlines CEO Scott Kirby and Stan Deal, head of Boeing’s commercial division, signed a giant airplane order in December 2022 in South Carolina…
These data show that the Leicestershire area of Melton saw the most significant increase in wages.
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Document management, often referred to as a document management system (DMS), is the use of a computer system and software to store, manage, and track electronic documents and electronic images of paper-based information captured at the using a document scanner. The Document Management System (DMS) market is constantly evolving, driven by the need for increased efficiency in the workplace. Improving technologies and efficient execution of DMS should gradually eliminate the traditional concept of paper records.
Document Management Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis. It also provides market information in terms of development and its capacities.
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Some of the Top Companies Influencing in this Market includes:
Various factors are responsible for the market’s growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Document Management market. This report is a consolidation of primary and secondary research, which provides market size, share, dynamics, and forecast for various segments and sub-segments considering the macro and micro environmental factors. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market.
Global Document Management Market research report offers:
For Any Query or Customization
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Global Document Management Market Segmentation:
Market Segmentation by Type:
On-premise
Cloud-based
Market Segmentation by Application:
Government
Healthcare
BFSI
Others
Regions Covered in the Global Document Management Market Report 2020:
? The Middle East and Africa (GCC Countries and Egypt)
? North America (the United States, Mexico, and Canada)
? South America (Brazil etc.)
? Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
? Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
The cost analysis of the Global Document Management Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.
Key questions answered in the report include:
Table of Contents
Global Document Management Market Research Report 2021 – 2028
Chapter 1 Document Management Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Production, Revenue (Value) by Region
Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions
Chapter 6 Global Production, Revenue (Value), Price Trend by Type
Chapter 7 Global Market Analysis by Application
Chapter 8 Manufacturing Cost Analysis
Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10 Marketing Strategy Analysis, Distributors/Traders
Chapter 11 Market Effect Factors Analysis
Chapter 12 Global Document Management Market Forecast
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COMTEX_416740905/2769/2022-10-16T08:52:13

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Collaborative Applications Market
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Today, there’s a CLM software for almost every business, whether it’s small or an enterprise. It’s no surprise since contract management software increases productivity, saves time, automates tasks, improves contract management efficiency, and cuts costs.
Manual contract management requires a lot of time and effort. Research shows that companies lose 9.2% of their annual revenue due to ineffective document management. The average cost of a contract varies from $6,900 for simple contracts to $49,000 for complex ones. And as the number of documents rises almost everyday, so do management costs. Consequently, switching to a contract lifecycle management system is no longer an option, but rather a necessity.
The Problem
Choosing a solution is a big deal as there are many things to consider. It may be a hard undertaking since the CLM software market has become enormous with lots and lots of vendors. There are hundreds, if not thousands, of solutions to choose from that offer different functions, services, and prices.
However, a wide variety of options is not the only challenge. The other is finding out how much it will cost. If you google solutions, you’ll see a wide range of prices with the cheapest at less than $1/month. That seems pretty nice, but…
…the reasonable question regarding what you’ll get arises. Will it cover all your needs, or perhaps the price shown is only for some basic features like centralized storage? Most likely, you’ll need more than that.
Price is one of the most important aspects when you’re choosing the right CLM system and pitching this software to your stakeholders. Without knowing what it’s based on, you won’t be able to calculate the ROI.
The problem is that prices aren’t really visible. Quite often, when visiting a provider’s website, you have to book a demo to discover what their pricing is. This starts an endless sales cycle that you might not be ready for. The research process becomes multifold, often leading to an understanding that while the software might be great, you just spent hours on calls only to discover that it’s way out of your budget.
Revealing the Truth About What Exactly Shapes CLM Prices
Most of the factors that determine the price for a contract lifecycle management solution are related to the company’s size. This is reasonable considering that big enterprises usually have more complex workflows and customizations than small businesses. Below, we highlight 9 various aspects that influence the price of CLM software:
Knowing what the price of CLM software is based on will help you make a more informed decision when choosing one. These are the main factors that impact the price, but there are still other things you should be aware of. If you’re not, you may be in for a shock when you receive the final bill.
· Number of users. Some software pricing structures are based on the quantity of users. For particular solutions, these costs may impact the cost per month. That’s why enterprises usually pay significantly more for contract management software than smaller companies.
· Features. The simplest CLM solutions cover only one stage of the contract lifecycle. More complex platforms offer a wide variety of features, such as automation, reporting, analytics, template libraries, notifications, collaboration, and much more. But don’t fall for a million features. It’s better if the solution is scalable, so you can get additional features when your business needs them.
· Integrations. Some operational processes may need third-party integrations, such as. CRMs, eSign, and messaging apps. Some vendors charge for such integrations. That means the more integrations there are, the higher the price is.
· Storage. The amount of documents stored impacts the price. But besides size, additional capabilities like smart search may be charged separately.
· Security. Keeping data safe is a top priority for any business. Breaches may cost businesses millions of dollars and reputational losses. So while security may not affect the price of plans, companies that provide better, more reliable, and more robust security measures may be naturally a bit more expensive. But considering the potential losses from a security breach, it may be well worth the investment.
· Volume of documents. Generally speaking, the more documents you process, the higher the price. Some companies allow you to pick a plan that covers a certain number of documents, and if you exceed that number, you pay a bit more. This permits some degree of flexibility as you can start small and see what you need before scaling up.
· Number of workflows. Similar to volume, the greater the number of workflows or templates that need to be supported, the more you should expect to pay.
· Advanced tech. This could be the implementation of artificial intelligence, machine learning, or some other technology that provides a hand in completing work. But before you fork over the cash for AI, you’ll want to have a discussion about whether or not you really need it, as well as what are the costs and benefits for you.
· “A la carte”. By this, we mean the ability to mix, match, and combine any or all of the previously mentioned price factors. Companies usually price their services as a set, Combination of all or any of the above and less obvious costs, described below.
Hidden costs
The cost of CLMs consist of the essentials above. You can calculate it and the sum may seem acceptable. But that doesn’t mean it’s the final cost. It can be much higher because of additional fees you weren’t informed about.
The most common additional fees are charged for the following services:
Implementation. Configuring user accounts, setting up workflows, and automating contract templates may cost additional money. There are three standard approaches for implementation: 1) An implementation fee paid in addition to the software cost; 2) Implementation is included in the software cost; and 3) Implementation on your own (which is likely free, but may lead to unnecessary headache and stress).
Customization. Vendors often charge additional fees to customize a CLM to your needs. So, if you want to get something more than basic features, or if you simply need particular features for your existing workflow, you’ll have to pay more.
Team training. Most likely, your employees do not know how to use the new software. It takes time and effort to learn before they can start fully using it. CLM providers will help you with that, but some of them charge extra for educational meetups.
Customer support. If you don’t clarify the terms of this service, it may cost you an arm and a leg. Technical assistance can be provided completely for free, for a fee, or with conditions (i.e. only during business hours on weekdays).
Add-ons. Many vendors may offer essential business add-ons such as e-Sign for additional fees. Such details can make the invoice much bigger than what you expected.
Legacy data migration. If you want to avoid being forced to manage multiple storage systems, you’ll want to migrate your legacy contracts and data to the new system. However, this takes time and a bit of effort, and that usually means an extra fee.
When choosing and negotiating with a vendor, make sure to cover all the basics and find out if it’s included in the final price or not.
Starting Point
And once you do have the space in your budget, don’t rush for the cheapest, the most feature-heavy, or the most famous solution. You first need to understand your business’ CLM software requirements. Start by assessing how your company will use the software so that you know what needs it should cover.
To determine your requirements for a contract lifecycle management system, you should analyze your existing document workflow. There are some points you should consider first and foremost:
· The number of ‘everyday’ users. Think about all employees from different departments that will need access to the platform: sales, procurement, finance, and legal. Each one plays an important role in contract lifecycles.
· The number of documents. Conscientiously evaluate the current volume of contract flow in your organization and how many contracts you process. And don’t forget your legacy contracts, because some vendors charge for the amount of documents stored. This number will change, so consider what growth plan you may need. The good news is that some providers offer upgrades to a larger storage size if there’s a demand.
· Types of documents. This is important since it makes it easier for you to choose the features and solution’s necessary capabilities. For example, if you frequently work with large documents and need to quickly process them, it’s unlikely you’ll want a CLM that needs 30 minutes to do it.
· Cross-department collaboration. Usually, there are at least two departments involved in document creation. Analyze how your employees collaborate on contracts, how the redlining process goes, and what would you like to improve.
· Third-party collaboration. Frequently, contracts are negotiated with third parties. Consider how documents are being shared, how access is granted, and how the negotiation process proceeds. Documents may contain sensitive information, so it’s not only about collaboration, but also about security.
· Approvals. Analyze your approval process. It’s one of the longest stages of the contract lifecycle, and usually it involves many people and opinions, making it a real mess. If this sounds familiar, you’ll want a CLM that will allow you to check if all parties have completed their reviews and whose approval is still needed.
· Esignatures. Esignature software allows you to sign documents no matter where the approver is. If you need to add attachments to the contract, such as status information, recipient/sender information, delivery tracking, or signature progress, this service will prove useful.
· Metadata storage. Metadata usually refers to the basic information about a contract so that it’s easier to find and retrieve data. It may be the company name, creation date, document type, governing law, counterparty name, etc. If you work with a wide array of contract types, consider a solution that has the possibility of adding necessary metadata and advanced search.
These are the main things to consider when you decide to switch to a CLM platform. Without knowing a business’ essential needs, you run the risk of ending up with the wrong solution, which won’t make your professional life easier, but harder instead.
Wrapping Up
Every organization’s situation is unique to them, so some of the factors above will play a larger role than others. That’s why when you’re in the process of choosing a CLM solution, you should pay close attention to what’s essential for you.
AXDRAFT strives to respect not only the time of their clients, but also the time of potential clients. The team at AXDRAFT will always be available for consultation and help regarding whether or not certain software is a good fit for your organization. And, no holds barred, we’ll tell you if we’re not the right fit, so that you don’t waste time having conversations that lead to a dead end. But, should circumstances change, our door is always open.
Contract lifecycle management is designed to make your professional life easier, and finding the optimal solution shouldn’t be a hard task. To simplify matters, AXDRAFT will work towards coming up with the best pricing option that works for you. As we can accommodate the needs of any company, we always recommend starting small and scaling later. Should you have any questions, please feel free to reach out whenever is best for you.
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Jul 16, 2020  |   Microsoft Philippines Communications Team
In any firm, big or small, transactions between departments and across functions expose companies to missed opportunities, non-compliance, and even financial vulnerability. At the center are countless documents that carry important information, which are crucial to running a business.
In this era of digitization, most companies still route paper files and manage their compliance manually — practices which are time-consuming, labor-intensive, and prone to errors. Yet as remote work has become the new norm created by COVID-19, document and compliance management through manual means has ceased to be viable.
Championing the digital shift of integral business processes, systems integrator and application developer Paperless Trail Inc. highlights the importance of embracing the “new normal” in doing business. Responding to the difficulties encountered by organizations through technology, Paperless Trail Inc. developed industry-leading solutions that effectively move compliance and document management to the digital space. In the last 10 years, Paperless Trail Inc.’s applications Archive One, Activity Factory, and Go Paperless! have become essential tools for forward-looking businesses looking to spend less time on administrative tasks, and more on high-value work that produces long-term results.
Self-regulation through Archive One
Archive One is a document management software (DMS) that serves as an auditing tool, which seamlessly classifies, stores, secures, and retrieves essential documents. It is particularly helpful in the IT-BPM sector, whose companies usually employ thousands of individuals, therefore giving companies a huge amount of data to track.
Paperless Trail Inc. Technical Director Jay Edades shares, “Human Resources departments have to track and update employee data to ensure each worker’s records are complete when filing taxes or assisting with health benefits and social security claims. They also have to provide relevant information to certain clients about employees working on those accounts. With Archive One, we ease the burden of digitization work and fix the method data for each employee in order to make complete reports.”
Archive One has also been used by the financial sector to audit all information related to a particular transaction. For example, if a client spends P100,000, Archive One can give a breakdown of the transaction along with all the related attachments found in the system. This allows for easy tracking of transaction numbers, voucher numbers and supporting documents to enable the team to account for missing or inaccurate paperwork.
“The biggest impact of Archive One is that it tells executives if the information they have is complete and if they are compliant with standard procedures,” Edades explains.
Remote document routing made easy by Activity Factory
Paperless Trail also deploys Activity Factory, a workflow software that eliminates paper forms and the manual conduct of routing and approvals. It utilizes a checklist system that breaks down the workflow of business-wide operations into concrete steps. Files can be attached to each step in the workflow to signal compliance, and the platform only clears the team to advance once each checkpoint is fulfilled by the designated employee.
Through these checkpoints, businesses can audit themselves by having the software ensure that the paperwork is complete for each juncture in the process. Since it follows a workflow that assigns steps to certain people, it immediately determines where the bottlenecks are in the system and therefore promotes accountability in the organization.
According to Edades, Activity Factory is especially helpful to financial institutions involved in credit and loan application processes, and the manufacturing sector tasked with meeting ISO quality standards.
Go Paperless! for managing countless pages of documents
Complementing the two applications is Go Paperless!, the scanning service brand of Paperless Trail that has become the go-to solution of many businesses of all sizes in the Philippines. It has scanned over 250 million pages to date and offers image conversion to searchable text through indexing for easier information retrieval.
Go Paperless! enables the digital storage of business records and addresses the challenge of storing and retrieving paper-based documents. This, according to Edades, supports companies into going digital as part of their long-term strategy. “Once your records are digitized, you only need the press of a button to access everything you need to run your business. It frees up physical space and gives nearly real-time access to any document that you need,” Edades adds.
AI-Processing and information security
Edades emphasizes that Paperless Trail’s solutions not only optimize business processes and allow teams to work more efficiently, but they also address a key concern among executives: data security.
“We acknowledge that each page contains sensitive information and the reason we built these applications is to prevent hacking, mishandling of data, missing documentation, and mitigate other data security risks. Our programs are built to automate along with necessary safeguards that uphold the information security of our partners,” Edades reiterates.
Paperless Trail’s services are powered by Microsoft Artificial Intelligence (AI) which helps in digitizing thousands of documents daily by extracting text from images and conducting word analysis for contextualizing information.
Edades quips, “Running Microsoft AI together with our own technology gives our solutions a stronger backbone. It also gives us and our clients a solid sense of security especially as we handle sensitive and complex information in millions of documents. We are thrilled to have found a partner in Microsoft as we champion the digitization of compliance and business processes of companies in the Philippines.”
Dec 21, 2022   |   Microsoft Philippines Communications Team
Dec 15, 2022   |   Microsoft Philippines Communications Team
Nov 25, 2022   |   Microsoft Philippines Communications Team
Nov 15, 2022   |   Microsoft Philippines Communications Team
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WASHINGTON, Dec. 27, 2022 /PRNewswire/ — GoodFirms, the globally renowned research, ratings, and reviews platform, recently announced the latest list of the best task management software. The identified task management platforms make it easy for organizations to prioritize tasks, share updates, and organize and manage everything from a single dashboard.

Best Task Management Software at GoodFirms:
TaskQue, Intervals, Beesbusy, Flowlu, TaskOnBOt, Trello, Todoist, Asana, monday.com, Smartsheet.
Businesses often face the challenge of managing multiple projects and the tasks to accomplish. Factors like time, budget, resources, man-management, communication, etc., require stringent monitoring to complete the project successfully. So today, most companies are taking advantage of task management software to perform projects in a well-organized manner and effectively.

Task management software allows individuals to log into a task management dashboard to have flexible working hours for employees working from home or on the go. It also allows managers and teams to achieve deadlines, track the time of specific tasks, set priorities, track progress, attend meetings, allocate resources appropriately, and optimize all projects effectively.
"Task management software integrates automation for recurring tasks, and also generates reports that help in tracking the performance and gain useful insights."
Key features of the best task management tool include collaboration tools, document management, portfolio management, progress tracking, project budgeting, project planning, project scheduling, reporting, task management, team collaboration, resource management and time tracking. Service seekers can choose task management software that covers all the features and obtain additional benefits for optimizing the workflow and  improving productivity.
With this year-end listing, GoodFirms aims to assist service seekers in choosing the perfect task management software that helps organizations to create a better work-life balance and enhance productivity in the coming years. Organizations can also take advantage of the advanced filter options for features, pricing models, devices supported, deployment, business size, etc. Furthermore, they can also verify the most reviewed, top-rated tools and select the suitable system.
Here at GoodFirms, businesses can also find a list of various tools for specific requirements like document management software, project planning software, time tracking software, employee engagement software, collaboration software, appointment scheduling software, and reporting software.
Best Document Management Software:
eFileCabinet, OnlyOffice, KRYSTAL DMS, Dokmee, dMACQ DMS, Zoho Docs, Alfresco Content Services, OpenKM, M-Files, DocuWare.
Best Project Planning Software:
Magic Projects, Taiga, Evernote, Zoho Projects, Wrike, Teamwork Projects, Celoxis, Freedcamp, Toggl Plan, LiquidPlanner.
Best Time Tracking Software:
TMetric, WebWorker Time Tracker, Trackabi, TaskBlast, Eddy, Time Doctor, QuickBooks Time, Replicon, TimeCamp, Clockify.
Best Collaboration Software:
Troop Messenger, Microsoft 365, Basecamp, Zoho projects, Airtable, Miro, Notion, Webex, GoToMeeting, Google Workspace.
Best Reporting Software:
Whatagraph, datapine, Tableau, Zoho Analytics, Zoho Projects, Teamwork Projects, Bitrix24, iVisit, QuickBooks Commerce, ActiveCollab.
GoodFirms follows a strict methodology to conduct thorough research based on quality, reliability, and ability to cater to the needs of service seekers. The task management software list was created based on several parameters such as the background of each product, the company, years of experience in the domain areas, online market penetration, client feedback, and much more. Only those companies that attained the maximum score made it to the list.
If you are a task management software service provider and wish to get listed, you can partake in the GoodFirms research processes. Interestingly, gaining the top position among the best service providers will attract the attention of potential prospects, increase productivity, help generate more sales, and earn more profit.
About GoodFirms:
GoodFirms is a Washington, D.C.-based B2B research firm specializing in identifying the most prominent and efficient IT companies and software providers that can automate the tasks of various industries. GoodFirms' industry-wide research, review & rankings help service seekers leap further and multiply their industry-wide value and credibility.
Contact: Sophia Jayden (sophia@goodfirms.co)

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By Marcelo Trevino, Agendia
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, SaMD IVD's intended use, classification, clinical/performance requirements, and the content of the technical documentation must comply with these regulations. In my last article, I described how to know if FDA and EU regulators qualify your software as an IVD SaMD. This article builds on that foundation and summarizes the regulatory framework required for IVD SaMD in the U.S. and European markets.
In the U.S., IVD SaMD is classified according to risk-based criteria based on the intended use, then software is categorized by level of concern to establish the evidence required. There are four steps involved in the classification:
1. Select the appropriate device type regulation: There are three sections of regulations that cover IVD devices: 21 CFR Part 862 Clinical Chemistry and Clinical Toxicology, 21 CFR Part 864 Hematology and Pathology, and 21 CFR Part 866 Immunology and Microbiology.
2. Determine the appropriate device risk classification: There are three levels: Class I (low to moderate risk, general controls required), Class II (moderate to high risk, general controls and special controls required), or Class III (highest risk, general controls and premarket approval required).
3. Review device classification exceptions: Depending on the applicable regulations associated with the device, some devices might be exempt from premarket notification requirements.
4. Determine the associated product codes: Based on the applicable regulation number, FDA’s product classification database shall be used to review available product codes to identify predicate devices and the substantial equivalence information.
The “level of concern” refers to an estimate of the severity of injury that a device could permit or inflict, either directly or indirectly, on a patient or operator as a result of device failures, design flaws, or simply by virtue of employing the device for its intended use. There are three levels of concern for device software in the U.S.: major, moderate, and minor. To establish the level of concern, manufacturers should answer questions provided in FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and establish a rationale. This will determine the amount of documentation required in the premarket submission. FDA considers IVD software to be at least a moderate level of concern because software flaws could indirectly affect a patient and could potentially result in injury.
After the software is qualified as an IVD, the manufacturer shall define its intended use, since the intended use determines the regulatory classification of the software. The intended use shall capture the software’s core functionality and the effect of the information provided for healthcare decisions.
Once the software is qualified as an in vitro diagnostic medical device, the next step is to determine its risk class based on Annex VIII of Regulation (EU) 2017/746.
Rule 1.4 of Annex VIII indicates: “Software, which drives a device or influences the use of a device, shall fall within the same class as the device; If the software is independent of any other device, it shall be classified in its own right.”
Rule 1.8 of Annex VIII indicates: “Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class.” Rule 1.9. of Annex VIII indicates: “If several classification rules apply to the same device, the rule resulting in the higher classification shall apply.”
MDCG 2019-11 provides examples of classification. However, it is important to note that these examples should not be considered confirmation of the final device’s classification, as manufacturers shall consider all the rules under Annex VIII for the in vitro diagnostic medical device software according to its intended purpose, and the justification should be documented in the device’s technical documentation.
In the EU, once a software qualifies as an in vitro diagnostic medical device, the manufacturer must demonstrate compliance with the 20 general safety and performance requirements detailed in Annex I of Regulation (EU) 2017/746. If some of these are not applicable, a justification must be provided. Software compliance can be supported through the use of different harmonized standards such as EN ISO 14971:2019 for medical device risk management.
Below are the relevant GSPRs affecting software:
GSPR 13.2(d) requires devices to be designed and manufactured in such a way as to remove or reduce as far as possible the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts.
GSPR 16 focuses on software and includes four points:
GSPR 20.4.1 (ah) addresses information required in the instructions for use and requires that the instructions for use for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall contain minimum requirements concerning hardware, IT network characteristics, and IT security measures, including protection against unauthorized access, necessary to run the software as intended.
Software performance must also be demonstrated. MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software provides guidance on the level of evidence required according to the EU 2017/746 IVD Regulation.
FDA and EU IVDR regulators require clinical evidence through performance evaluation. FDA and EU recognize IMDRF/SaMD/WG/N41 Final: 2017 for demonstrating clinical evaluation of SaMD in general. In the EU, there is an additional guidance provided for IVD SaMD: MDCG-2020-1 Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software.
To demonstrate that the IVD SaMD performs as intended, manufacturers shall demonstrate that the software is designed using recognized standards and also that it can achieve its medical purpose safely and effectively. If the IVD SaMD uses an algorithm that must be trained to perform as intended, manufacturers shall provide a conclusion that the algorithm works for its medical purpose as part of the analytical and clinical performance evidence. Regulatory agencies in the U.S. and the EU will expect to see a description of the data sets used to evaluate the software, including inclusion or exclusion criteria, clinical site descriptions, number of subjects, algorithm development processes, statistical models used, and performance measures for verification and validation. Any claimed benefits must be supported with clinical evidence based on performance evaluation.
A valid clinical association shall be established between the IVD SaMD output and the target clinical condition and clinical studies to evaluate analytical and clinical performance. Effective performance of the SaMD’s intended use shall be demonstrated through analytical performance (demonstration that the software processes input data to generate accurate output data, which may include analytical sensitivity, analytical specificity, bias, precision, accuracy, limits of detection, and method comparison) and clinical performance (the analytical use of the software applied to the target population in a clinical care setting achieving its stated intended purpose or claimed benefit, which can be demonstrated referencing existing data from studies performed for the same intended use or by generating new clinical data for the specific software’s intended use).
For the EU, Annexes II and III of 2017/746 IVD Regulation provide details on the technical documentation that must be gathered for the software. EN 62304 provides good guidance to ensure most requirements are adequately addressed and the documentation generated according to EN 62304 standard allows a large part of the regulatory requirements to be met. The information to be provided includes, among others: an overview of the entire system and a description of the data interpretation methodology, a summary of the results of all verification, validation, and testing applicable in a real-world usage environment, labeling information, configurations, and operating systems required.
Similarly, FDA’s draft guidance Content of Premarket Submissions for Device Software Functions and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices provide details on the recommended documentation that software manufacturers should include in premarket submissions. This includes, for example, software description, system and software architecture diagrams, risk management file, device hazard analysis for software devices, software design specifications, software level of concern classification, and verification and validation activities, among others.
As part of the Medical Device User Fee Amendment V (MDUFA V) passed by the U.S. Congress on Sept. 30, 2022, FDA established several Digital Health Commitments to be accomplished between fiscal year 2023 and fiscal year 2027 that will continue to build its digital health expertise and work to streamline and align their review processes with software life cycles for digital health products. The following are the six Digital Health Commitments:
Conclusion
As SaMD becomes more predominant in the medical device world, it is important for manufacturers and developers to understand how to qualify an IVD SaMD and then to establish the analytical and clinical claims for the software to define its intended use, since this is how performance will be assessed by regulators to comply with regulatory requirements. IMDRF/SaMD WG/41 Final: 2017 is a thorough guidance document on how to approach performance evaluation for IVD SaMD, which is crucial to demonstrate that the IVD SaMD is safe and effective. There are many guidance documents and tools available to aid manufacturers through the IVD SaMD regulatory process, particularly driven by FDA’s CDRH Digital Health Center of Excellence, which provides digital health expertise and policy direction that manufacturers and developers should take advantage of. This is particularly important as many embark in IVD SaMD development activities that continue to evolve rapidly as artificial intelligence and machine learning applications continue growing in the medical device world.
About The Author:
Marcelo Trevino is the global vice president, regulatory affairs and quality assurance at Agendia, a molecular diagnostics company focused on breast cancer genomic testing. He has more than 20 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles with different medical device organizations. He has an extensive knowledge of medical device management systems and medical device regulations worldwide. Trevino holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at ASU. He is also a certified Medical Device Master Auditor and QMS Master Auditor by Exemplar Global. He can be reached at marcelotrevino@outlook.com or on LinkedIn.

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The Latest published a market study on Global Credential Management Solutions Market provides an overview of the current market dynamics in the Credential Management Solutions space, as well as what our survey respondents— all outsourcing decision-makers— predict the market will look like in 2028. The study breaks the market by revenue and volume (wherever applicable) and price history to estimate the size and trend analysis and identify gaps and opportunities. Some of the players that are in coverage of the study are SkyXoft Technologies, Inc. (Canada), Smartsheet Inc. (United States), MedTrainer (United States), Hyland Software (United States), ideal privileges (United States), SkillSurvey (United States), NetForum (united States), Applied Statistics & Management (United States), Vistaar Technologies, Inc. (United States), IntelliSoft Group (United States).
Get Free Exclusive PDF Sample Copy of This Research @ https://www.advancemarketanalytics.com/sample-report/127967-global-credential-management-solutions-market#utm_source=DigitalJournal/Rahul
Scope of the Report of Credential Management Solutions
Credential management solutions are used to control access to sensitive data, organizations require user credentials. Deploying a sound credential management system—or several credential management systems—is critical to secure all systems and information. Authorities must be able to create and revoke credentials as customers and employees come and go or simply change roles, and as business processes and policies evolve. Furthermore, the rise of privacy regulations and other security mandates increases the need for organizations to demonstrate the ability to validate the identity of online consumers and internal privileged users.
The titled segments and sub-section of the market are illuminated below:
by Application (Appointment Management, Committee Management, Document Management, Online Applications, Privileging, Others), Organization Size (Small & Medium Enterprises (SMEs), Large Enterprises), Platform (Mac, IPad, Android, Linux, Others), End Use Industry (BFSI, Retail, Telecommunication, Government/Public Sector, Healthcare, Real Estate, Energy and Power, Manufacturing, Others), Deployment (Cloud-Based, On-Premises), Pricing Type (Monthly Subscription, Annual Subscription, One-Time License)
Market Trends:
Tamper-Evident and Intrusion-Resistant HSMs Provide the Highest Level of Physical Security
Opportunities:
Demand for Credential Management Solutions for Data Security in the Cloud Environment
Achieve Point-To-Point Encryption by Complying With PCI Standards
Market Drivers:
Growing Number of Data Breaches and Cyberattacks across the World
Effective Management of Cryptographic Keys
Stringent Government Regulations for Security and Privacy of Data
 
What can be explored with the Credential Management Solutions Market Study?
o  Track Right Markets
o  Identify the Right Verticals
Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa
Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.
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Strategic Points Covered in Table of Content of Global Credential Management Solutions Market:
Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Credential Management Solutions market
Chapter 2: Exclusive Summary – the basic information of the Credential Management Solutions Market.
Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges & Opportunities of the Credential Management Solutions
Chapter 4: Presenting the Credential Management Solutions Market Factor Analysis, Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.
Chapter 5: Displaying the by Type, End User and Region/Country 2015-2020
Chapter 6: Evaluating the leading manufacturers of the Credential Management Solutions market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile
Chapter 7: To evaluate the market by segments, by countries and by Manufacturers/Company with revenue share and sales by key countries in these various regions (2021-2027)
Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source
finally, Credential Management Solutions Market is a valuable source of guidance for individuals and companies.
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The 6 Best Contract Management Software for 2023  Investopedia
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Xerox Emirates has signed a partnership agreement with KOFAX in the UAE to help customers transform information using Intelligent Automation software
Dubai, UAE: Xerox Emirates, the industry experts in cutting-edge print and digital solutions have expanded their partnership with KOFAX in the UAE. Working with KOFAX, a leading supplier of Intelligent Automation (IA) software, Xerox Emirates will provide a stronger value proposition for digital workflows providing customers with intelligent automation to accelerate business transformation.
KOFAX, a software provider with a strong portfolio of workflow and content management solutions, help organizations become more productive, improve service levels and reduce operating costs. This partnership will further enable Xerox Emirates to sell, market, deploy, and support Kofax TotalAgility — an intelligent software that automates touchpoints which previously required human intervention. This UAE partnership will help organizations to extend the value of Xerox's managed print services offering, to enhance their transformation roadmaps.
By collaborating, Xerox Emirates and KOFAX will help customers to transform information and intensive business processes achieving their digital transformation goals more quickly. By equipping companies of all sizes to meet their document and content management challenges, the new partnership will allow Xerox Emirates to extend its market reach and benefit from incremental revenue streams.
Mutually beneficial to both companies; KOFAX will provide joint customers with software solutions, while Xerox Emirates Digital Services will continue to provide their professional services and resources for implementation, integration in addition to leveraging the existing customer base.
Customers looking for Xerox MPS, ECM, or AI/Data Mining solutions, can now reach out to Xerox Emirates to deliver more services through their strong partnerships and third-party solutions.
Simon Howells, General Manager at Xerox Emirates LLC said: “The shift to ‘digital first’ to stay ahead of a rapidly changing landscape continues to be a top priority for Xerox Emirates in line with the UAE’s digital transformation agenda. It is our mission to deliver these goals by developing and implementing innovative and scalable solutions that deliver measurable benefits for our customers.
“Utilizing our Digital Services capabilities in conjunction with Kofax Intelligent Automation software, Xerox Emirates can collaborate with our clients to identify and deploy the right solution, that removes pain points, and drives accelerated transformation.”
“Kofax and Xerox Emirates build upon their strategic collaboration within the intelligent document processing industry with hyper intelligent automation solutions and deep industry experience that will greatly facilitate our combined customers’ digital transformation journeys.” said Chris Strammiello, Vice President Channel Sales at KOFAX.
As part of the strategic partnership, Xerox Emirates customers will benefit from a range of Kofax’s intelligent automation solutions including:
Kofax TotalAgility® which accelerates high-value business journeys to a positive result by orchestrating individual touchpoints in those journeys and cuts latency between the touchpoints and so delivering more value at each human touchpoint and linking traditional and digital channels. It intelligently automates touchpoints that previously required human intervention and can remove the need for analog and paper-based interactions entirely.
Kofax Claims Agility was purpose-built to extract all data present on medical forms, and greatly improve the efficiency of staff by automatically detecting and classifying professional and institutional claims, associate and track supporting documents, and trains the system to identify and classify claim types. Digitizing these documents enables authorized individuals to quickly access each claim case file to support inquiries, corrections, and follow-ups with subscribers, providers and internally as well.
Kofax AP Agility is a world-class solution that provides organizations with a comprehensive set of capabilities for digitally transforming the accounts payable process by intelligently capturing data from invoices in 30+ languages, perform automated GL coding, manage approvals and exceptions, and integrate Kofax with their ERP systems through pre-built connectors, along with an agnostic ERP connector.
Kofax AP Essentials, formerly known as ReadSoft Online, provides market-leading capture, extraction and validation for invoice processing. Its configurable business rules, general ledger coding and user driven approval and exception workflows are offered on Microsoft Azure.
Kofax Process Director™ offers a single platform for handling a wide range of document-driven and request-driven business processes within your SAP® system. Combined with Kofax’s invoice automation and intelligent capture solutions, Process Director offers a complete suite of tools that help you maximize your SAP investment, while automating your critical SAP financial processes.
Kofax Intelligent Automation is a software platform that transforms information-intensive business operations from start to finish for business and IT executives who need to apply artificial intelligence (AI), robotic process automation (RPA) and other digital technology, hence empowering organizations to transform the capacity and performance of their operation, improve customer engagement and exploit new business opportunities.
Increase productivity, efficiency, and compliance so employees can focus on higher-value work by automating routine, repetitive tasks. Part of the industry leading Kofax Intelligent Automation Platform, Kofax Robotic Process Automation (RPA) makes end-to-end automation happen.
Leading organizations worldwide in banking, insurance, healthcare, manufacturing, retail and many other industries rely on Kofax SignDoc for easy and secure digital transactions. SignDoc offers the benefits of trustworthy and convenient paperless signing for a wide variety of functions including customer and employee onboarding, procurement, account management, service documentation, payroll and finance.
Kofax Power PDF Advanced is the leading PDF solution that makes it easy to gain control over PDF workflows in every department and for every use. Kofax Power PDF Advanced is the only PDF solution that delivers ease of use and accuracy as never before, freeing you from the compromises of traditional PDF applications.
Kofax ControlSuite™ is an on-ramp for your digital transformation initiatives. By augmenting MFDs with intelligent automation capabilities connecting to business systems, ControlSuite provides increased efficiencies and productivity while maximizing document security. Capture, print and mobile workflows are enhanced with an interactive predictive analytics dashboard and deliver a unified user experience across a multi-fleet environment while supporting modern cloud-based services.
Accelerating Digital Transformation with XEM Digital Services
With over 15 years of expertise in Digital Services, Xerox Emirates has firmly established its reputation in the region as a leading provider of Digital Services for businesses to simplify work and improve productivity. They have been at the forefront of innovation in document technology with a portfolio that encompasses services and solutions ranging from Enterprise Content Management, Document Management Systems, Capture and Digitization, Business Process Automation, Advanced Analytics, Machine Learning, Artificial Intelligence and more.
-Ends-
About Xerox
Xerox Holdings Corporation makes everyday work better. We are a workplace technology company building and integrating software and hardware for enterprises large and small. As customers seek to manage information across digital and physical platforms, Xerox delivers a seamless, secure, and sustainable experience. Whether inventing the copier, Ethernet, the laser printer or more, Xerox has long defined the modern work experience. Learn how that innovation continues at xerox.com.
About Xerox Emirates
A leader in document management technology, Xerox Emirates is at the core of software and hardware integration, helping businesses on their digital transformation journey. Delivering greater productivity and efficiency by automating workflows and digitizing data. A joint venture between the Xerox Corporation and the Mohamed Hareb Al Otaiba (MHAO) Group, uniting to bring pioneering technology with local expertise.  Our diverse portfolio of innovative technologies deliver #BeyondCMYK production presses, intuitive user experiences and benchmark security that enables the evolution to next generation services.
For any media enquiries, please contact:
Nitya Sabina | nitya.sabina@xeroxuae.ae
House of Comms | XeroxEmirates@houseofcomms.com

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