21 CFR Part 11 Training

In 1997, the FDA released 21 CFR Part 11 to ensure the security of electronic signatures in the production cycle of life science companies. The following year, MasterControl Inc. released the first software solution to address 21 CFR Part 11 training and compliance. MasterControl has helped hundreds of FDA regulated companies around the world implement 21 CFR Part 11 training software solutions exceeding the agency’s strictest requirements.

White Paper Downloads on 21 CFR Part 11

	White Paper: MasterControl's Product Positioning in Regards to 21 CFR Part 11 - Automating the Management of Documentation
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper: 21 CFR Part 11 - Risk of Non-compliance
	White Paper : 5 Ways to Ensure System Compliance with 21 CFR Part 11
Click here to view all available resources.

About MasterControl Inc.
MasterControl Inc. is a leading provider of GxP process management software specifically created for FDA regulated life science companies. With more than a decade of experience, MasterControl provides 21 CFR Part 11 training software solutions to help companies address the challenges of conducting business within the rigorous FDA environment. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their 21 CFR Part 11 training software investment across the enterprise.

Implementing Industry Best Practice 21 CFR Part 11 Training
In order to provide a complete approach to 21 CFR Part 11 training, MasterControl’s regulatory compliant GxP process management software provides the following:

1. System SOPs: include System Administration and Configuration SOP, User Administration and Management SOP, and Document Control Sop. These system-specific SOPs support validation documents.
2. User Authentication: allows system administrators to monitor and track the active accounts of every user in the system. MasterControl 21 CFR Part 11 training software has numerous levels of security to ensure authenticity of each user.
3. Access Security: includes dual passwords for document approval, password expiration, password encryption, password certification, account lockout remote access security, and auto log out of idle workstations.
4. Audit Trail: maintains a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record.
5. Record Retention: allows companies to set up their own record retention policy by document type. This record retention policy can be set indefinitely or only for a specific period of time.

MasterControl 21 CFR Part 11 training software solutions allow companies to automate, streamline, and effectively manage the GxP processes in every department across their enterprise.

Subscribe to GxP Lifeline
MasterControl’s complimentary monthly newsletter, GxP Lifeline, is a valuable educational and research resource for life science companies looking to stay abreast of life science regulations, events, and news.

Contact MasterControl Today
Under 21 CFR Part 11 training regulations, electronic record-keeping systems must be validated in order to ensure the accuracy, reliability, and consistent intended performance of the system and the employees that use it. To learn more about MasterControl’s 21 CFR Part 11 training software solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

Related Items:

• 21 CFR 11
• 21 CFR Part 11 Compliance
• 21 CFR Part 11 Software
• FDA Guidelines
• GMP Guidelines
• GMP Regulation
• Regulated Market
• FDA
• Regulatory Compliance
• FDA Inspection