| Comment Record|
Mr. Dennis Tajiri ||
2003-03-06 17:52:41 |
Mr. Dennis Tajiri |
| Comments for FDA General |
1. General Comments
Thanks for your message.
Unfortunately, the agency is backing away from part 11 safeguards, and
meaningful regulation of the industry, in general. See the attached
documents. I encourage you to send your comments to the indicated docket.
You might also want to attend an April workshop and let FDAers hear your
From: Dennis T. Tajiri [mailto:email@example.com]
Sent: Thursday, March 06, 2003 2:48 PM
I've been working in Part 11 Computer Validation as a contractor for the
past several years. I worked at Genentech, AMGen, and Bayer as a full time
employee and have put the big block buster products into the clinic and have
designed the production facilities. Namely, Tissue Plasminogen Activator
(Genentech), Erythropoietin (AMGen), and recombinant Factor VIII (Bayer). I
have experience with Process Control, PC based databases, and Analytical
Instrumentation validation. I am one of the few with the skill set. I
learned the fundamentals by performing Part 11 Assessments for Biotech and
Big Pharma. My clients have included but not limited to:
Scios, Aviron (now MedImmune), Matrix Pharma, B. Braun Medical, Wyeth, AHP,
NicePak, Novartis, Immunex (now AMGen) Rhode Island, PowderJect, Bayer,
Merck, Avecia, Genzyme, Pharmacia/Pfizer, Schering Plough, and Abgenix.
I have a unique perspective in this field because I have seen and evaluated
work from not only other contractors but also Equipment vendors with the so
called canned validation packages.
I can see your concern to simplify the guidelines but I get the sense that
some companies may interpret this as a loosening up the stringency of
validating certain systems. I've performed Risk Assessments as well and can
see the need to prioritize systems based on this analysis. I have to say
the industry is all over the board on level of compliance. Contractors are
also raising the bar and maybe over interpreting the guidelines by taking a
conservative approach. I have done this as well to prevent criticism of not
performing a functional test that I felt was critical.
The other observation is the lack of preparation of User Requirements and
Functional Specs and use of FAT and SATs in the software design and code
review. Its getting to the point where we as consultants are getting pushed
into a corner by the Clients needing to get their production facilities
I have been working with Software development companies on the use of new
state of the art Part 11 Compliant document management and Wrapper
technologies. There are developments that can literally revolutionize the
industry. Its been hard to convince clients without cost justification of
using this new technology. We've been able to work with forward thinking
companies but I believe you can be instrumental in the adoption of new
I would like to also propose a set of guidelines for minimally required
software tests for system categories: 1. BAS 2. DCS/SCADAs 3. Process
PLCs 4. Analytical Instrumentation 5. OTS 6. Custom Configurable Software
7. Custom Scripting or program development (eg., Java or other
Client/Server based software)
You can reply to my email or feel free to contact me by cell phone and we
can discuss this in greater detail.
Thank you for your consideration in this matter.
Dennis T. Tajiri
707-803-2071 cell phone