FDA has published more than 30 documents related to computer systems and computer validation, and the term computer validation is no longer foreign to the industry. Computer-validation practices and regulations are evolving and reaching the maturity
stage of other validation disciplines, even if more recently it seems that the efforts on computer validation and Part 11
compliance are less apparent than before. This complacency might be a result of the wait-and-see attitude toward what the
new Part 11 regulation amendment might bring and may also result from the perception that computer validation–related 483
observations have decreased in recent years.
The intent of Part 11 regulations was to allow businesses to be more efficient, to enable automation, and to generate less
paper documentation. Yet, these goals have not been fully realized. Most companies addressed how to meet and comply with the
Part 11 regulations, but they did not necessarily develop business strategies to take full advantage of what the regulations
allow the companies to do.
As technology evolves, computer validation also will change. We will see what the next 10–30 years bring. Could we see programmable
drugs based on nanotechnology? For example, one article suggests that nanodiamonds could be useful in biological applications
such as carriers for drugs (27) or perhaps as bioerodible implants with programmable drug release (28). Computer validation
will need to be continuously simplified, standardized, and automated while reflecting the growing complexity of designed and
engineered drugs and delivery systems.
The authors thank Alan Kusinitz, managing partner of SoftwareCPR, and George R. Smith Jr., FDA consumer safety officer at
CDER's Office of Compliance, for their input and review.
Rory Budihandojo* is the computer validation manager at Boehringer-Ingelheim Chemicals and a member of Pharmaceutical Technology's editorial advisory board, firstname.lastname@example.org
Steve Coates is the director of computer system quality assurance at Wyeth. Ludwig Huber, PhD, is a compliance expert at Agilent Company. Jose E. Matos is manager of manufacturing systems and process automation at Bristol-Myers Squibb. Siegfried Schmitt, PhD, is the quality director at GE Healthcare Global IT. David Stokes is the life sciences manager at Business & Decision. Graham Tinsley is president of THINQ Compliance Ltd. Maribel Rios is senior editor of Pharmaceutical Technology.
*To whom all correspondence should be addressed. The scope of this article is specific to the healthcare industry and to the
view of the authors or FDA, which may not necessarily reflect the view of the companies where the authors and reviewers are
Where were you 30 years ago?
Rory: "I was in the UK, going to school."
1. E. Kübler-Ross, Five Stages of Grief,
2. Risk Management,
3. IVT Proposed Validation Standard VS-2, Computer System Validation, IVT 3 (2002).
4. Guide to Inspection of Computerized Systems in Drug Processing (1983),
5. Timeline of Key FDA Software Documents,
6. ITG Subject: The Computer in FDA-Regulated Industries (1976),
7. ITG Subject: The Computer in FDA-Regulated Industries Part II Computer Hardware (1977),
8. Guidance for Industry: Computerized Systems Used in Clinical Trials (1999),
9. Guide To Inspections of Computerized Systems in The Food Processing Industry (unclear publication date),