New white paper: Five tips for ensuring 21 CFR Part 11 compliance

August 22, 2006 — /MasterControl/ — SALT LAKE CITY UT USA — 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

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. For more information or additional white papers, visit www.mastercontrol.com or call 800-825-9117.

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