Shared accounts using common access credentials is a significant data integrity issue as it is impossible to attribute the action to a specific individual. A fundamental requirement for assuring the reliability and trustworthiness of records. Shared accounts are a fundamental non-compliance in any regulated industry. In the pharmaceutical industry they are a fundamental non-compliance with annex 11 (sections 12 and 14) or 21 CFR Part 11. Such a practice has attracted audit observations and warning letters.
In addition, you appear to be allocating system administrator privileges to operators. This is another GMP issues that has attracted audit observations and warning letters. Further, it is a very dangerous practice as it is probable that users have access to functions which they do not need for their roles, and probably have not been trained to use properly.
Dr David Trew
BSc (Hons), PhD, CChem MRSC
David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.
Telephone: +44 (0)1494 700693
The comments placed in this post are for information only are not intended to constitute any form of counsel.