21cfr part 11 is used for validating records dating a man with low self esteem

Systems designed to manage regulated electronic records are also subject to the requirements of 21 CFR Part 11.These include electronic document management systems (EDMS); warehouse management systems (WMS); materials resource planning (MRP) and enterprise resource planning (ERP) systems; programmable logic control (PLC), data control system (DCS), and supervisory control and data acquisition (SCADA) reporting systems; laboratory information management systems (LIMS); clinical trial management systems (CTMS); and maintenance and calibration systems (see Table I).

Since 1999, when the agency began to enforce the regulation, an FDA 21 CFR Part 11 task force has met with technology companies to discuss the extent to which their applications are compliant with the requirements of Part 11.These meetings have reinforced FDA's conviction that technologies are available to ensure that new systems comply with the regulation.The regulation provides no exemption for legacy systems—no grandfathering.However, recognizing the technical challenge of bringing these systems into compliance, FDA will be more lenient in reviewing them.It is designed essentially to minimize the possibility of data misappropriation.

Part 11 focuses on ensuring the authenticity of data, the integrity of data and systems, the confidentiality of data (particularly with respect to clinical trials and blood banks), and the nonrepudiation of electronic signatures.A company that is out of compliance with FDA regulations may be hit with an FDA Form 483, a warning letter, an injunction (which can include a market recall or ban on importation), or a consent decree.A review of warning letters relating to Part 11 deficiencies was conducted in early 2002 to analyze the causes of noncompliance.Implementing a compliance program requires focus, consistency, and a methodical approach.Whatever the exact shape of its implementation methodology, a company must take an approach that accomplishes the following.The following controls are applicable to both closed and open systems.