Access Database Life Cycle Management
Access databases are widely used throughout the life science industry whether it is in labs, manufacturing, research, or clinical settings. The reasons why these databases continue to be a solution of choice are well known: ease of use, familiarity with the application and ability to share data.
However, there are risks inherent in using databases including input errors, lack of an audit trail, poor version and change control, and lack of security.
Whether they are used for manufacturing logs, batch data, storing patient data, training records, or clinical trial data; knowing, managing, and controlling databases is an important part of GxP, and ensuring they meet 21 CFR Part 11 compliance regulations is critical.
Part 11 Compliance
If your databases are used in support of predicate rules, they must comply with 21 CFR Part 11 requirements for security, audit trail, and eSignatures.
eInfotree Access Module is an easy-to-use, plug-in to Access that allows for all of these controls to be added without modifying the user experience. Business continues without any adoption or training issues because the application in use hasn't changed. eInfotree Access Module helps meet compliance regulations but also increases transparency in database actions while ensuring no changes occur that can't be audited and reported on.