SALT LAKE CITY UT USA - August 24, 2006 - Validation of electronic record-keeping systems is critical to overall FDA compliance. The principle behind 21 CFR Part 11's validation requirement is to ensure accuracy, reliability, and consistent intended performance of the system and to determine invalid or altered records.
About the White Paper
www.mastercontrol.com/land/email/part-11-white-paper-5-tips.html This white paper prepared by MasterControl Inc., offers practical "Good System Implementation Practice" tips to help improve your validation documentation and ensure your system's Part 11 compliance.
MasterControl's recommendations cover five key areas:
- System SOPs
- User Authentication
- Access security
- Audit trail
- Record retention About MasterControl MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993.
Over 400 companies worldwide use the MasterControl solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements.
In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services.