Jokes apart, Microsoft Office is tough to replace. You can use Microsoft Office 365 in a web browser on Linux but that needs a subscription and may not provide an ideal experience.
So, I’m here with a list of the best open-source word processors for Linux to make your life easier without that.
Please note that I am talking about word processors here, not a full-fledged office suite. The focus is on suggesting tools that let you write documents. Some software may come with spreadsheets and presentation software but that’s not our goal here.
The first line of this article is partly true, especially for the Linux people.
I said goodbye to Windows just 2 years back, and even as a professional writer and Linux user, I hardly miss MS word.
So let’s check out some of the useful features you may expect before going through the list of free and open-source word processors.
A good word processor should:
Do you agree with me? Cool! Let’s see what options do you have here.
Some of the mentioned applications are offline while some are web-applications. I’ve also included a few closed-source word processors based on their Linux availability and free plan at the end of the article so that you have a choice here.
In addition, a few options come as an office suite, while others are standalone word processors. I’ll try to mention packages as such.
Just so as you know, this is not a ranking list.
AbiWord is an open-source word processor exclusive to the Linux community.
AbiWord has a clean and clutter-free interface. From the get-go, you’ll notice where to find the essentials.
All the important functions are visible upfront, reducing the guesswork. It also has an AbiCollab feature for multiple users working simultaneously on the same document.
Finally, it lets you save documents in countless formats and correct misspelled words. However, the import is not such a luxury. Still, you can use files created with MS Word, LibreOffice, etc.
You can directly install AbiWord from the respective Linux repository or Flathub.
LibreOffice is the default word processor in almost every Linux distribution.
Similar to the previous option, the user interface is intuitive. It lets you feel productive the moment you open it.
Moreover, it’s a complete office suite, similar to MS office.
Its import-export options are plentiful. Most probably, you won’t feel any compatibility issues with documents created with other word processors.
Like with every change, coming from MS word may feel slightly strange at first. But nevertheless, it’s capable and user-friendly to get you through almost all your word processor requirements.
It’s available for the most popular OSes: Linux, Windows, and Mac.
(Apache) OpenOffice word used to be identical to LibreOffice or the other way round because LibreOffice was forked from OpenOffice. While OpenOffice seems to be slow on development, LibreOffice has become the de-facto open source office suite.
Yes, they both come as office suites and support opening documents in multiple formats.
Likewise, OpenOffice writer is a capable word processor which is available for free.
This can open various formats, including the .docx format. However, you can’t save in that. So that can be limiting in exporting.
Apache OpenOffice Writer is officially available for Linux, Windows, and Mac.
Calligra Gemini is a free, open-source office suite that has taken a unique approach for its word processor, Calligra Word.
If ‘different’ is your style, you should definitely try the Calligra Word. Coming from any of the above options–you’ll feel alienated straightaway.
And that’s not a bad thing. One can feel fresh with Calligra Words as well. Import-export options are great, and you can save them in MS Word formats.
Notably, Calligra words has a powerful spell-checker.
Calligra word can be downloaded for Linux, Windows, Mac, and FreeBSD.
OnlyOffice is a close cousin of MS office. But, it has a free and open-source version-OnlyOffice Desktop. It’s extremely compatible with MS Word and a lookalike.
That being said, you can open and edit documents created with LibreOffice (and the like) as well. This also has a nifty spell checker.
It has a cloud version too–free and paid. You can use its free web application to collaborate with multiple users.
Finally, you’ll feel right at home if you’re coming from the Microsoft ecosystem. It’s a well-packed and feature-rich word processor.
OnlyOffice can be downloaded on Linux, Mac, and Windows.
Pardon me if I said Calligra Word looks alien. No. That phrase fits perfectly with WordGrinder.
Frankly, it feels like a typewriter with a screen. You will fall in love with WordGrinder if you cherish minimalism. Its distraction-free atmosphere does away with the mouse.
But realistically, this terminal-centric application is best for novelists. And that’s exactly why it was coded by David Given. The most you can do other than grinding words is italicize, embolden, or underline.
It can import in ODT, HTML, and text, while the export has support for LaTex, Troff, etc., in addition to the import formats.
You can use this on Windows and Unix-like operating systems.
CryptPad is for the Edward Snodens. It’s a privacy-focused collaborative web application in that it doesn’t even ask for email or your name.
It’s encrypted and open-source. You can use this as a guest, registered user, or premium user. The premium tier is obviously paid and requires an email address.
You can switch to an intrusion-free interface with just a click. In addition, it has abundant word processing prowess. But unfortunately, it only supports .html, .md, and .doc formats.  
All CryptPad files are stored locally unless you use CryptDrive. Guest mode deletes cloud-stored files after 90 days. The registered mode comes with the bumped-up dedicated personal space (1 GB) and upload functionality. The premium tier enhances these abilities.
Finally, there is no reason you shouldn’t give CryptPad a try.
EtherPad is an open-source collaborative web tool that mostly isn’t cross-compatible with other word processors. Etherpad uses its own format, HTML, and plain text to save and open the files.
It has a clean look and almost a friendly user interface for the minimalists. You can set up your Etherpad instance or use publicly available ones. Public instances are set up on specific public servers, and your files won’t be private.
Setting up an individual instance is not difficult at all. It’s just a few commands for people on Debian and Ubuntu. Besides, Windows’s installation isn’t difficult either.
Etherpad can also be used as a docker image.
Non-FOSS alert: The following options are not open-source but available for free on Linux.
In a bid to replace the MS office, Softmaker’s FreeOffice announces itself as the best free alternative. It lets you switch between the ribbon view and the classic view.
Needless to say, FreeOffice is compatible with MS Word formats. And this can also open files by other word processors mentioned in this article. However, it can only export in either its own or MS word formats.
This word processor is powerful with great aesthetics. It also has a paid version with added features such as a German grammar checker, citation, and reference management abilities.
It is available for Linux, Windows, and Mac. Thus, it provides a way to use Microsoft Office documents on Linux.
Similar to FreeOffice, the WPS office has a free and paid version. This is the most cross-platform-friendly, closed-source option on this list.
This is extremely feature-rich with a capable free version if you don’t mind ads. However, the WPS office at times feels laggy.
WPS Office also has a stripped-down cloud application similar to Microsoft office online. This web version is targeted at collaborations.
It’s available for Linux, Windows, Mac, iOS, and Android.
These were some of the great tools that have come of age.
Though all have certain strengths, I personally felt great about AbiWord, OnlyOffice, Calligra Word, and WordGrinder (for novelists).
And if you want the best MS word alternative, I would recommend looking no further than OnlyOffice. Please share any utility if we missed anything and your general impressions about these tools in the comment section.

Hitesh is a technology writer. He also has a flavor for acoustic guitar. And academically, he’s a postgraduate in Transportation Engineering & Management. You can check his complete work at hiteshsant.com/.
This article is a community submission by an It’s FOSS reader who is not a member of the regular It’s FOSS team. The views and opinions expressed are those of the authors and do not necessarily reflect the official view and policy of It’s FOSS.
If you want to contribute under community submission, feel free to contact us.
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You missed FocusWriter. https://gottcode.org/focuswriter/ I’ve used it to bang out stuff that later gets into one of my books.https://theminimumyouneedtoknow.com It has minimal text formatting and most people use it in full screen mode so they can “focus,” hence the name. It’s very capable though.
Thanks for the suggestion, we’ll take a look!
@kokushta & bruce:
There are other ways of paying other than money. Microsoft does not let you sign up for Office.com out of altruism and the goodness of their black hearts. You pay with your personal data and access to the documents you create.
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Adept Ranks #1 in Usability, Implementation, Support, Adoption and Relationship in G2’s Summer 2022 Reports
G2 Summer Reports name Synergis Adept a leader in Enterprise Content Management for the 8th consecutive quarter, including over 40 #1 rankings for usability, support, user adoption, implementation, and business relationships. (Graphic: Business Wire)
G2 Summer Reports name Synergis Adept a leader in Enterprise Content Management for the 8th consecutive quarter, including over 40 #1 rankings for usability, support, user adoption, implementation, and business relationships. (Graphic: Business Wire)

QUAKERTOWN, Pa.–(BUSINESS WIRE)–Synergis Software, a global leader in engineering document management and workflow solutions, today announced that Synergis Adept has earned over 40 #1 rankings in G2’s Summer 2022 Grid Reports. These first-place rankings cross over four categories: Enterprise Content Management, Product Data Management, Construction Management, and Construction Drawing Management.

“The G2 reports highlight Adept’s advantages customers value most—usability, fast and easy implementation, responsive support, high user adoption, and a partner that is easy to do business with,” says Scott Lamond, vice president of marketing at Synergis Software. “Thanks to our customers, Adept has maintained these top placements for eight consecutive quarters. We are truly grateful for the trust and loyalty of our remarkable global community.”
A consistent theme throughout the summer reviews is Adept’s flexibility and ease of use, searching, and configuration. Customers also value Adept’s unique vaulting methodology, which doesn’t move or scramble files in a proprietary database and its reliable, centralized platform that delivers fast access to drawings documents in a secure environment from anywhere.
Quotes from Verified Users about Synergis Adept
“The product is very good but any product that is not well supported is useless. Synergis has the BEST support service I have ever seen in the software industry.”
Howard Shapiro, Automation Project Manager, Novozymes North America
“Adept is a straightforward, feature rich system. The document vault uses the file names, not some crazy hashed out naming scheme like so many other systems. Tech support is top notch!”
Brian Cranston, CAD Designer/Administrator, LSI Industries
“Adept is our central engineering drawing repository for equipment across all of our plants. The system allows engineers to enter, revise, and store the most recent documentation, while also having the ability to view past revisions. It provides view and print capabilities of up-to-date prints to personnel in maintenance, operations, and purchasing.”
Emily McCarty, Project Engineering Specialist, Timken Steel
The G2 reports are based on direct customer response combined with G2’s unique algorithm that calculates customer satisfaction and market presence scores in real-time.
The G2 Summer 2022 badges for Synergis Adept include:
For more details about Adept in the G2 Spring 2022 Reports, visit our website.
About Synergis Software
Synergis Software is a global leader in document management and workflow solutions and is the creator of Synergis Adept software. Adept serves more than 120,000 users across dozens of industries providing fast, centralized access to design and business documents in a secure, collaborative environment. Adept Integrator connects your enterprise applications so data and business processes flow seamlessly across the entire IT infrastructure.
Synergis was named the customer service leader in the global engineering information management market by Frost & Sullivan and ranked in the Top 5 globally by Helpdesk International for three consecutive years.
Adept has been proven by engineers for over 30 years with customers such as Dow Chemical, Con Edison, General Mills, Merck, NASA, and Nucor Steel.
For more information, visit SynergisSoftware.com.
About G2 Crowd
G2 is the world’s largest and most trusted tech marketplace where people can discover, review, and manage the software they need to reach their potential. More than 3M people visit G2 to read and write reviews about thousands of software products and services.
Scott Lamond
Vice President of Marketing
Email: scott.lamond@synergis.com
Phone: 215-302-3006.
Synergis Adept was named a leader in ECM by G2 for the 8th consecutive quarter with 40+ #1 rankings in usability, adoption, implementation, & support.
Scott Lamond
Vice President of Marketing
Email: scott.lamond@synergis.com
Phone: 215-302-3006.

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Capital Project Management Software Market
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Toronto-based MinuteBox has raised a $5 million CAD ($4 million USD) seed round led by Michael and Richard Hyatt to fuel its expansion plans.
Co-founded by a group of former lawyers, MinuteBox provides cloud-based legal entity management software. Like other legaltech startups, MinuteBox saw demand for its solution increase during the pandemic as COVID-19 led slow-moving, traditionally tech-conservative law firms switched to the cloud by necessity to stay in business.
“After the initial confusion and uncertainty wore off … we really saw the business start to accelerate incredibly.”
-Daniel Levine, MinuteBox
Now, with the backing and guidance of experienced operators in the brothers behind BlueCat—MinuteBox aims to build on its pandemic growth and capture more of the North American market for cloud-based legal solutions.
“We were just set to go to market in and around when the pandemic hit,” MinuteBox co-founder and CEO Daniel Levine told BetaKit in an interview. “What was amazing [was] after the initial confusion and uncertainty wore off … we really saw the business start to accelerate incredibly.”
Founded by Levine, Steven Pulver, Sean Bernstein, and Brian Hunt (who joined the startup following its 2019 acquisition of Conductor), MinuteBox provides law firms with tools for safely and securely managing and creating digital minute books and corporate records on behalf of clients. The startup’s software solution offers cloud storage, document automation, and e-signature capabilities, and permits users to easily visualize reports, ledgers, registers, ownership charts, and cap tables without the need to generate PDFs.
Levine attributed MinuteBox’s recent growth to COVID-19 forcing law firms had previously been slow to shift to the cloud being “in a situation where, not only were they now bought into the idea”—but they were ramping up their adoption of cloud “for business continuity purposes.”
“We had the right product, at the right time, and the right service,” Levine said.
RELATED: After a year of rapid growth, Athennian extends Series A round by $7 million
MinuteBox’s all-equity seed financing was led by the Hyatt brothers, with support from Cowie Capital and Jai Shekhawat, the founder and former CEO of Fieldglass. The round represents the startup’s first venture funding to date.
“Despite having a lot of interest from other firms, we knew that we wanted to go with [the Hyatts],” said Levine. “These are, in Michael and Richard, two experienced operators that have been through everything and anything one can [go] through as an entrepreneur, and just have a tremendous amount of mentorship and advice that they can provide.”
Michael Hyatt has joined MinuteBox’s board as part of the round. Hyatt told BetaKit that MinuteBox has “a lot of excellent client traction, strong sales growth, a great team and a very sticky product.” The entrepreneur-turned-investor added that he was impressed by the list of “marquee enterprise clients” the startup has added to date.
MinuteBox’s customers include three of Canada’s “Seven Sisters” law firms—which includes Blakes, Davies, Goodmans, McCarthy, Osler, Stikeman, and Torys—and one of the Big Four accounting firms (Deloitte, Ernst & Young, KPMG, and PwC).
RELATED: Michael Hyatt joins Northleaf Capital Partners as senior advisor
Toronto-based law firm Loopstra Nixon LLP, an early adopter of MinuteBox, chose the startup’s platform to help modernize its corporate law practice and aid its transition to cloud. “They have been instrumental in helping us transform our corporate records management system into a more accurate and accessible system for our clients,” said Loopstra Nixon LLP Partner Michael Otto.
MinuteBox, which enables corporate legal professionals to easily share, work, and collaborate with each other at scale, claims it is “the only no-code legal entity cloud.”
The startup operates in the legal entity management space, a segment that features big-name competitors like New York’s Diligent and fellow upstarts like Calgary-based Athennian.
MinuteBox and Athennian are both members of Canada’s rapidly expanding legaltech sector, which includes startups like Lawbrokr, Goodlawyer, Blue J, Willful, ClearEstate, and Heirlume, as well as more established players like Dye & Durham and Clio.
RELATED: Clio alum launches legaltech startup Lawbrokr to match consumers with lawyers
The legaltech firm plans to use the fresh capital to grow its 25-person team and invest in product development. In addition to the funding, MinuteBox has announced the official launch of its new MinuteBox App Store. According to MinuteBox, its app store is “the first and only” legal entity management marketplace.
Although its current focus is on Canada and the United States, Levine sees room for MinuteBox to grow into other markets as well.
“I think there’s tremendous opportunity, not just in North America but around the world, particularly in common law countries, where this idea of entity management and legal compliance and governance is really a new thing in most markets,” said Levine.
Hyatt, who “believes strongly in legal technology as a growth opportunity,” sees opportunity for MinuteBox’s solution beyond just law firms. “It’s not just law firms,” said Hyatt. “It’s law firms and many regular enterprises that have entity management and filing needs. We see real demand across our portfolio of companies.”
With files from Meagan Simpson.
Feature image courtesy MinuteBox.
Josh Scott is a BetaKit reporter focused on telling and breaking Canadian tech and innovation stories. His coverage is more complete than his moustache.

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A new covert attack campaign singled out multiple military and weapons contractor companies with spear-phishing emails to trigger a multi-stage infection process designed to deploy an unknown payload on compromised machines.
The highly-targeted intrusions, dubbed STEEP#MAVERICK by Securonix, also targeted a strategic supplier to the F-35 Lightning II fighter aircraft.
“The attack was carried out starting in late summer 2022 targeting at least two high-profile military contractor companies,” Den Iuzvyk, Tim Peck, and Oleg Kolesnikov said in an analysis.
Infection chains begin with a phishing mail with a ZIP archive attachment containing a shortcut file that claims to be a PDF document about “Company & Benefits,” which is then used to retrieve a stager — an initial binary that’s used to download the desired malware — from a remote server.
This PowerShell stager sets the stage for a “robust chain of stagers” that progresses through seven more steps, when the final PowerShell script executes a remote payload “header.png” hosted on a server named “terma[.]app.”
“While we were able to download and analyze the header.png file, we were not able to decode it as we believe the campaign was completed and our theory is that the file was replaced in order to prevent further analysis,” the researchers explained.
“Our attempts to decode the payload would only produce garbage data.”
What’s notable about the modus operandi is the incorporation of obfuscated code designed to thwart analysis, in addition to scanning for the presence of debugging software and halt the execution if the system language is set to Chinese or Russian.
The malware is also designed to verify the amount of physical memory, and once again terminate itself if it’s less than 4GB. Also included is a check for virtualization infrastructure to determine if the malware is being executed in an analysis environment or sandbox.
But if this test fails, rather than simply quitting the execution, the malware disables system network adapters, reconfigures Windows Firewall to block all inbound and outbound traffic, recursively deletes data in all drives, and shuts down the computer.
Should all these checks pass, the PowerShell stager proceeds to disable logging, add Windows Defender exclusions for LNK, RAR, and EXE files, and establish persistence via a scheduled task or Windows Registry modifications.
“Overall, it is clear that this attack was relatively sophisticated with the malicious threat actor paying specific attention to OPSEC,” the researchers noted. “While this was a very targeted attack, the tactics and techniques used are well known and it is important to stay vigilant.”
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New Procore product enhancements continue to support the needs of its customers around the world.
Procore’s new collaborative document management solution, coming soon, will make it easier and faster to access and collaborate on documents. (Graphic: Business Wire)
Procore’s new collaborative document management solution, coming soon, will make it easier and faster to access and collaborate on documents. (Graphic: Business Wire)
New Procore product enhancements continue to support the needs of its customers around the world. (Graphic: Business Wire)

CARPINTERIA, Calif.–(BUSINESS WIRE)–Procore Technologies, Inc. (NYSE: PCOR), a leading provider of construction management software, today announced multiple platform updates to further meet the needs of its global customers — from document control to data and privacy enhancements. Used in over 125 countries, Procore’s platform is continually advancing to provide customers with everything they need to meet business and security needs worldwide.

“Procore builds software for the people who build the world,” said Tooey Courtemanche, Procore founder and CEO. “Our platform enhancements for customizability, security, privacy, storage, and collaborative document management will benefit both existing and new customers as we continue to expand internationally.”
Collaborative Document Management Goes Global
Procore is taking its world-class document solution global to improve how the industry collaborates on construction documents across all project stakeholders. This is often a fragmented and inefficient process with construction teams using multiple disconnected solutions for versioning, markup, and workflow management. In 2020, 90 million documents were uploaded to the Procore platform. Procore’s new collaborative document management solution, coming soon, will offer a more flexible and configurable approach, making it easier and faster to access and collaborate on documents. It will provide customers with an integrated markup experience, offer custom approval workflows with granular file level permissions, and provide a solution that helps them meet common data environment (CDE) requirements and ISO compliance standards.
“We use Procore to manage documents on our projects and to digitise our inspections and snagging processes,” said Philip Lambourne MSc MCIOB, head of design and information management at Henry Boot Construction Limited in the UK. “The level of support Procore offered with configuring the platform and its usability was largely the reason behind our decision to select them. The support provided is vital, not only for our internal employees but for all our supply chain partners.”
“For all Procore customers around the world, this will provide a single location for all project documents, from preconstruction through closeout, and can only be accomplished with a true platform offering unlimited users, unlimited data and unlimited collaboration on every project,” said Wyatt Jenkins, Procore’s Senior Vice President of Product.
Global Cloud Infrastructure and Security Features to Meet Global Needs
Procore has expanded its global infrastructure with 11 new cloud data centers for file storage, now 15 in total, that allow customers to store certain project data locally, while also improving the speed and performance of the platform. Procore provides enterprise grade security and privacy features such as data encryption-at-rest, managed bug bounty program, strict access control policies, and more. Procore solutions can assist customers in meeting their data privacy and governance requirements, including GDPR, California’s Consumer Privacy Act (CCPA) and Australia’s Privacy Act of 1988 — learn more here.
Platform Flexibility and Global Enhancements Drive Customer Success
With feedback from global customers, Procore is building customization into the platform to meet the diverse needs of customers around the world. Whether building an inspection test plan in Australia or contractual correspondence in Germany, Procore’s customizable platform flexes to support regional business needs. Custom and Configurable fields are now supported by every product across the platform.
For Dean Hopkins, chief operations officer at Oxford Properties, “Procore is a big part of creating a global development platform, where we can benefit from what teams in Australia are doing and learning, and that can actually translate to what we’re doing in North America on projects, and then also to our teams in Europe on projects. Procore is at the center of collaboration that activates this global pool of expertise.”
Industry Votes Procore as Top Construction Platform Solution
Procore was recently named the tenth best software company in the world on The Software Report’s list of 100 Top Software Companies of 2021, and received top honors from G2 in eight categories of software: construction management, construction project management, bid management, construction ERP, construction drawing management, construction accounting, punch list, and jobsite management software.
To learn more about these platform enhancements, register and join Procore virtually at Groundbreak, the company’s annual conference being held October 12-14.
Forward-looking Statements
This press release contains forward-looking statements about Procore and its industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including, but not limited to: statements regarding the expected performance of Procore’s business and objectives of management for future operations, are forward-looking statements. Procore has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that Procore believes may affect its business, financial condition, and operating results. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, and other factors that could cause results to differ materially from Procore’s current expectations. You should not place undue reliance on Procore’s forward-looking statements. Procore assumes no obligation to update any forward-looking statements to reflect events or circumstances that exist or change after the date on which they were made, except as required by law.
About Procore
Procore is a leading provider of construction management software. Over 1 million projects and more than $1 trillion USD in construction volume have run on Procore’s platform. Procore’s platform connects key project stakeholders to solutions Procore has built specifically for the construction industry—for the owner, the general contractor, and the specialty contractor. Procore’s App Marketplace has a multitude of partner solutions that integrate seamlessly with Procore’s platform, giving construction professionals the freedom to connect with what works best for them. Headquartered in Carpinteria, California, Procore has offices around the globe. Learn more at Procore.com.

Media Contact
Raelle Alfaro
press@procore.com
Investor Contact
Matthew Puljiz
ir@procore.com
Media Contact
Raelle Alfaro
press@procore.com
Investor Contact
Matthew Puljiz
ir@procore.com

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Legal Hold Software
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DUBLIN, Aug. 2, 2022 /PRNewswire/ — Final days to register for the “Analytical Instrument Qualification and System Validation” training course that has been added to ResearchAndMarkets.com’s offering.
This 2-day course guides attendees through equipment qualification, calibration, and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.
Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance.
Recent EU and FDA reports demonstrate that qualification, validation, and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.
Learning Objectives:
Learn about the regulatory background and requirements for equipment qualification according to USP
Be able to explain the difference between equipment calibration, qualification, and system validation
Learn which equipment/systems need to be qualified or validated
Be able to allocate equipment and systems to USP
Understand the logic and principles of instrument qualification and system validation from planning to reporting
Be able to develop a qualification and validation strategy
Understand how to archive raw data from hybrid systems: electronic vs. paper
Be able to define and demonstrate regulatory compliance to auditors and inspectors
Be able to develop inspection ready documentation
Learn how to ensure, document, and audit the integrity of GMP records
Who Should Attend:
IT/IS managers and system administrators
QA managers and personnel
Laboratory managers and supervisors
Analysts
Validation specialists
Software developers
Regulatory affairs
Training departments
Documentation departments
Consultants
Key Topics Covered:

Day 01 (10:00 AM – 5:00 PM EDT)

10.00 AM – 10.45 AM – Requirements and approaches for Analytical Instrument Qualification
FDA/EU, PIC/S requirements
Qualification/calibration issues in FDA inspections
USP General Chapter
The instrument qualification lifecycle
Prioritizing calibration/qualification activities
10.45 AM – 11.30 AM – Qualification in Practice
User requirement specifications
Installation qualification
Operational qualification
Preparing inspection-ready documentation
11:30 AM – 11:45 AM – Break

11.45 AM – 12.45 PM – Testing and deviation handling
Developing test protocols
Documenting test evidence
Review and approval of test results
Handling deviations
12:45 PM – 1:15 PM – Lunch

1.15 PM – 2.30 PM – Retrospective qualification and Requalification
Qualification of existing systems
Leveraging past experience
Time-based requalification
Event-based requalification
What and how much to test – risk-based approach
2.30 PM – 3.15 PM – Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Handling changes made by vendors
3.15 PM – 4.00 PM: Type and extend of qualification for USP Instrument Categories
The approach and benefits of instrument categories
How to identify the correct category: A, B, C
Type and extent of qualification for each category
Required procedures and qualification deliverables
Responsibilities for instrument qualification
4:00 PM – 4:15 PM – Break

4.15 PM – 5.00 PM – Requirements and approaches for GMP Computer Systems
21 CFR Part 211, Part 11, PIC/S, EU Annex 11
Most critical inspection findings
Which systems need to be validated
GAMP 5: A Risk based Approach to Laboratory Computerized Systems
Examples for risk assessment of computer systems
Validation of Laboratory Computer systems
Day 02 (10:00 AM – 5:00 PM EDT)

10.00 AM – 10.15 AM – Questions and answers from Day 1

10.15 AM – 11.00 AM – Validation and Use of Excel in the QC Laboratory
Designing spreadsheets for compliance
Validation approach for spreadsheets – single and multiple-use spreadsheets
When, what and how much to test?
GAMP 5 recommendations
How to ensure spreadsheet data integrity
11:00 AM – 11:15 AM – Break

11.15 AM – 12.15 PM – Configuration management and change control
The IEEE standard for configuration management
The change control process for planned changes
Unplanned changes
Upgrading software
What to test after changes
How to document changes
12.15 PM – 1.00 PM – Periodic revalidation of chromatography data systems
The approach and practice of periodic review
Using periodic review to reduce frequency of revalidation
Criteria for time-based revalidation
Incidents requiring revalidation
Validation tasks after installing security and other patches
1:00 PM – 1:45 PM – Lunch

1.45 PM – 2.30 PM – Handling raw data and other laboratory records
Definition of raw data: electronic vs. paper
Acquisition and recording of raw data
How to make accurate and complete copies of raw data
Changing records
Archiving of raw data and ready retrieval
2.30 PM – 3.00 PM – Ensuring Integrity and Security of GMP data
Most frequent security and integrity issues
The importance of electronic audit trails
Review of electronic audit trails: who, what, when, and how
3:00 PM – 3:15 PM – Break

3:15 PM – 4.30 PM – Auditing Laboratory Computer Systems
Using FDA inspection practice
Importance of data governance policy and controls
Preparing inspection-ready documentation
Responding to typical inspectional/audit observations
4.30 PM – 5.00 PM – Wrap up – Final questions and answers

Speakers:

Mark Powell
Fellow
Royal Society of Chemistry

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development.
During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies.
Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

For more information about this training visit https://www.researchandmarkets.com/r/81q441
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