|
|
Article: Practical solutions for 21 CFR part 11 compliance in the laboratory
- Article from:
- Pharmaceutical Technology
- Article date:
- January 1, 2002
- Author:
CopyrightCopyright Advanstar Communications, Inc. 2002. Provided by ProQuest LLC. (Hide copyright information)
|
Because FDA investigations commonly target computer-systems compliance within the laboratory, many challenges related to 21 CFR Part 11 have come to the forefront. Ensuring the integrity and security of laboratory records, particularly data files, is an enormous challenge with far-reaching implications that can be met with an add-on, noninvasive software solution.
Unique FDA compliance challenges often arise in a laboratory environment because of the variety of technologies in use and the diversity of tasks performed there by various personnel. FDA investigations commonly focus on a company's laboratories, a trend that is likely to continue as the agency increases its focus on ...