FDA CFR 11

FDA CFR 11 regulations officially make electronic quality records and signatures as viable as their paper-based counterparts.

FDA CFR 11 regulations require a variety of security and control measures to ensure that record-keeping systems are secure and uncompromised. MasterControl, a developer of state-of-the-art document control, quality management and product lifecycle management solutions, produces the software necessary to comply with FDA CFR 11 regulations every day.

View Videos Using MasterControl for FDA Compliance (3:53) Trouble-Free Validation with MasterControl (1:38) An Executive Perspective of MasterControl (2:12)

Free Downloads
	White Paper: 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?
	White Paper: 21 CFR Part 11 Risk of Non-compliance
	White Paper: 21 CFR Part 11 System Validation (Risk Management Plan)
	White Paper: 21 CFR Part 11: MasterControl Product Positioning

A Software Solution for FDA CFR 11 Compliance

Electronic systems allow any companies regulated by the FDA to manage business processes and quality issues in a fraction of the time that is required to accomplish these tasks with a paper-based system. Take a look at the features and benefits that MasterControl can offer to those companies that wish to comply with FDA CFR 11 regulations:

• FDA 21 CFR Part 11 Section 11.10 requires the assurance of the integrity of electronic records and the minimization of a repudiation by a signer. MasterControl's software solution allows system administrator to provide an assurance of documentation integrity by assigning and restricting permissions to users, to document vaults and even to specific documents within those vaults if necessary. MasterControl provides various levels of security to minimize the possibility of repudiation.


• FDA CFR 11 Sections 11.10i,k require that employees who will be using the software system be training to perform their assigned duties and that within the document control system there are revision control, change control and time-based sytem modification features. MasterControl provides training control management, document revision control, change control and time-based system modification features.


• FDA CFR 11 Section 11.50a and Section 11.70 require that a name, date/time of signing and a signature meaning be included on every electronic record and that those records be linked to their corresponding electronic documentation. MasterControl provides the fields necessary for all required data and additional fields in the case that more information is desired within a specific company environment. MasterControl also ensures that every signature along with it's appropriate information is linked to its respective record.

For More Information

To learn more about the MasterControl solutions that will allow your company or organization to comply with FDA CFR 11 regulations, please feel free to contact a MasterControl representative.