9 of the Best Online CSV Resources for Pharma Validation Professionals

Across the internet, there are millions of websites bursting with information about almost everything. The World Wide Web has become an invaluable resource, propping up our quest to learn more about our profession – especially in the world of validation.

Validation and more specifically, computer system validation (CSV) are areas that require considerable research, thought and attention at the beginning of any project. Whether it’s verifying your validation strategy, optimizing system testing or improving documentation, the internet provides a wealth of information to guide you in the right direction.

However, with there being so much information out there, how to do you get the answers you need in a time frame that doesn’t slow down your project?

We have put together a list of our top browser bookmarks for CSV related topics, in an effort to save you time when researching and verifying your work for your next project. Some of these are must have references for any CSV work, and some are just great resources for those more unorthodox questions.


1. LearnAboutGMP.com (formerly askaboutvalidation.com)

Learn About GMP

Originally starting as an online forum and blog, LearnAboutGMP has transformed into one of the most trusted and comprehensive online resources for validation professionals. While many its articles do focus on CSV practices, you will find articles and information from all areas of validation in a pharmaceutical/GMP setting. LearnAboutGMP.com now offers a range of online courses and training material that can be used for cGMP training and employee development.

Learn more here: http://learnaboutgmp.com/


2. Slideshare.net (part of LinkedIn)


Many of you have probably already heard of SlideShare or come across presentations hosted on the site in your professional environment. However, we have added the online slide deck and presentation sharing site to our list as it acts as a fantastic place to find insightful and educative presentations from other CSV professionals. With an excellent free text search option, simply type in some keywords (just like you would in Google), and get presented with a list of presentations around that topic. Here are some suggestions and slide decks to take a look at.

Learn more here: http://www.slideshare.net/

Search term “Computer System Validation.”



3. ISPE GAMP Community of Practice


While this is a members only online community we strongly recommend joining the groups to get first hand insights into the development of the GAMP best practice guides. Membership’s gives you access to most of the premium best practice guides, as well as the GAMP 5: A Risk Based Approach to Compliant GxP Systems guide, somewhat of a CSV bible from ISPE.

ISPE also has several blogs and articles that focus on computer system validation and other validation topics that are definitely worth exploring. An all-round great online resource for pharma CSV professionals.

Learn more here: http://www.ispe.org/


4. FDA CFR Code of Federal Regulations Title 21 (21 CFR Part 11)


We added the full 21 CFR Part 11 regulations from FDA as a link on our list because we believe it’s an essential reference that we all need to go back and consult from time to time. While the regulations themselves haven’t been updated in some time, it can sometimes be helpful to reference these regulations when you’re progressing through a CSV project or developing documentation.

Learn more here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11


5. EU Legislation EUDRALEX (containing Annex 11)


If you’re operating in Europe or working on projects over the pond you’ll certainly want to bookmark the EUDRALEX EU Legislation, which includes Volume 4 GMP. Similarly to FDA regulations, these aren’t often updated but always a valuable resource for reference.

Learn more here: http://ec.europa.eu/health/documents/eudralex/index_en.htm

Volume 4 Annex 11: http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf


6. Glossary of Computer System Software Development Terminology


Created and maintained by the FDA, this list contains a full glossary of terminology applicable to software development and computerized systems in FDA regulated industries. Leveraging this glossary will ensure your documentation uses consistent terminology with regards to the regulatory requirements. It’s in alphabetical form, making it pretty easy to find the terms you need. You can also CTRL + F (Command + F for Mac Users) and search the website to get results.

Learn more here: http://www.fda.gov/iceci/inspections/inspectionguides/ucm074875.htm


7. Health Canada Validation Guidelines for Pharmaceutical Dosage Forms


Yes. More regulation. But it’s important to be thorough when creating the best CSV resource list on the internet. The Health Canada Validation guidelines will give you some greater insights into what is expected and required when validating computerized systems in Canada. While the requirements and best practices don’t differ greatly from the US FDA regulations, there are subtle nuances that you should be aware of if operating in Canada.

Learn more here: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui_29-eng.php


8. FDA Warning Letters Database


This resource is exactly what it says it is. Heading to the FDA Warning Letter Database will give you a full listing of all Warning Letters that the FDA have issued. While a lot of these warning letters will regard issues that don’t touch computer system validation, it’s always helpful to understand what the regulators are thinking. Use this database to search for specific CSV related warning letters to know how specific validation approaches are being received by the FDA. The list is regularly updated, and is searchable by company, issuing office, subject, letters with responses and letters with closeout letters, as well as a free text search box.

Learn more here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/


9. LinkedIn Groups


LinkedIn groups may not be an obvious addition to a list of online CSV resources, but if harnessed and used well LinkedIn Groups can be a powerful tool for validation professionals in the Life Sciences. Whether you are looking to stay up-to-date with industry chatter, to connect with other CSV professionals or take part in the community forums, LinkedIn will be invaluable to you. Attempting something new in a current project, and need validation on your approach (excuse the pun!), ask the community on one of the many great validation and CSV related LinkedIn Groups. We’ve listed a few that we are members of below:

  • Pharma Validation Group – Join Now
  • Computerized Systems Validation – Join Now
  • IQ OQ PQ Validation – Join Now
  • Computer System Validation in Pharma Industry – Join Now
  • Validation & Regulatory Compliance Professionals – Join Now



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About the Author: Oliver Pearce

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