Common issues with existing databases include: lack of electronic signatures, lack of audit trails, and password management and aging violating compliance with 21 CFR Part 11. Our solutions provide compliance by tracking changes, controlling access, and preventing unauthorized changes to your database. PSC can help you implement and validate Ofni® Part 11 toolkit, QD® database, or Oracle® e-Records.
These tools can help you manage electronic records with strong security, audit trail, and electronic signatures. Improved security features will restrict database access to authorized personnel. All changes made for each record will be logged in an audit trail. Electronic signatures can be added to any form to allow records to be protected from any further changes once signed.
In partnership with Ofni Systems®, QD Technologies® and Oracle®, we can help you manage critical information and conform to FDA Good Manufacturing Practices (cGMP). Our partners are listed below: