Back to:

Automation Portals

MasterControl News

New White Paper: Five Ways to Ensure 21 CFR Part 11 Compliance

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.

Go to company's web site

Automation.com Real-time Information for the Automation Professional May. 25, 2012

Cart

Automation.com

NOTICE: Your use of Automation.com constitutes your agreement to the Legal Notices, Policies, Terms, and Conditions governing its use. You should review these terms before proceeding.Copyright © 2000-2010 Automation.com - automation.com, automationtechies.com, automationtechies, automationtechie, and Member-Match are all trade and service marks of Automation Resources, Inc. All Rights Reserved.