Q: What should be the ideal time period for re-qualification of a computerized system?
Is it three years, five years, or something else? I’m a bit confused, as there is no proper guidance available in GAMP5 or other industry guidelines.
A: There really is no “ideal time period” for re-qualification of a computerized system.
However, you should plan to conduct periodic reviews of your computerized systems, especially focusing on the number of issues and changes that have occurred since your last review and since your last system qualification/validation.
Systems that have experienced few changes or issues are not required to be re-qualified.
“Keep in mind that ‘changes’ may also include changes to personnel and procedures, in addition to changes to hardware and software.”
But keep in mind that “changes” may also include changes to personnel and procedures, in addition to changes to hardware and software.
Systems that have had many changes or issues — even in less than a year’s time — should be re-qualified.
In general, I recommend that you review a new system quarterly during its first year of operation, and then review it yearly thereafter unless major changes are made to it.
Answered by Janis Olson, Vice President of Regulatory and Quality Services at EduQuest, who served as an expert field investigator and regional director of information management resources during her 22-year career at FDA. Jan is a co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class. This class was originally developed to train FDA’s own investigators how to audit computerized systems, then was modified for industry. During the past 21 years, it has trained thousands of auditors, quality managers, and IT specialists in FDA-regulated companies.