Twenty Years Later - Y2K, CSV & the Strangnas Warning Letter

How much things have changed in 20 years! (Or have they?)

Two warning letters I posted about in July had a level of detail on computer issues that first brought this set of inspection findings to mind. [ Here is one: ] Reviewing this letter made me remember that the 20th anniversary of the letter was upcoming, which is today 11 JAN 2021. I mention Y2K because surviving that brought the FDA back to a new intensity on 21 CFR Part 11 and other computer issues. Once the world was sure everything wouldn't stop, it was time to refocus. { Yes, it was a real issue - if you doubt, PM me to ask about my VCR.}

In addition, this inspection was in the year 2000 and had a good deal of impact in the CSV world. (It predated the finalization of GAMP 4 in 2001.) As you will see in this post [ (16) Post | LinkedIn ] Y2K affected dating of the site records. Violation 1 called out a number of items that were both serious and still familiar perhaps?

a. The [ ] network program lacked adequate validation and/or documentation controls. For example:

• The system design documentation has not been maintained or updated throughout the life of the [ ] software dating back to 1985 despite significant changes and modification that have taken place. [Note - This inspection was 15 years later.] These include program code, functional/structural design, diagrams, specifications, and text description of other programs that interface with [ ].
• The program was not controlled by revision numbers to discriminate one revision from the other.....
• Significant deficiencies regarding documentation controls were reported. Documents were either not dated, lacked a documentation control number, were missing, were reported in pencil on uncontrolled pages, or dates were crossed out without initials, dates, or explanation.....

c. The wide area network also identified as the [ ] is used to connect network applications to local area networks [ ] at Strangnas API operational facilities. The [ ] and [ ] network applications at each site by departments using these programs to perform their GMP function. Both the [ ] and [ ] documentation were not included in the [ ] and [ ] validation efforts and therefore lacked adequate documentation controls.

There is a great deal more to be found in the 7 pages of this letter. It is worth your reading. You can find it here: WL: 320-0107 Perhaps you will find that your systems are in a good state of control - perhaps you will be reminded of some issues that have been put to the side because "you are looking forward to a replacement of the [ ] system with a new validated system in the near future." Hopefully you will not find similar issues with potential cross-contamination due to environmental design issues.

This letter is a classic. It is interesting to me that the key names are familiar and still with us. Bob Tollefsen and Thomas Arista are still active wit the FDA inspection team. Joe Famulare has now joined Genentech / Roche. I trust they will not object to being reminded of this letter. Their comments, as well as yours are most welcome. Please advise if there are any issues with the links.

#fda #api #gamp #y2k #part11