Understanding Audit Trail Requirements in Electronic GxP Systems

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records.  These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.  Therefore, we must ensureContinue reading “Understanding Audit Trail Requirements in Electronic GxP Systems”

Data Management Plan – Database Archive

Indicate how you intend to archive and share your data and why you have chosen that particular option. The DMP should outline specific information regarding the organization’s procedures for archiving the electronic records. Good practice for digital preservation requires that an organization address succession planning for digital assets. Which criteria will you use to decideContinue reading “Data Management Plan – Database Archive”