FDA 21 CFR Part 11 Inspection


Compliance with FDA 21 CFR Part 11 regulations requires training for the Part 11 validation of a company's electronic quality management system and to predefine processes before a FDA 21 CFR Part 11 inspection.

Whether a FDA-regulated company is training its employees on the basics of 21 CFR Part 11 or training employees to become users of a Part-11 compliant electronic system, part 11 training is essential to achieving FDA 21 CFR Part 11 inspection requirements.

The Part 11 validation requires careful testing and corresponding documentation. This documentation ensures that the electronic system has been programmed to perform the tasks necessary to maintain compliance with Part 11 rules and FDA 21 CFR Part 11 inspection regulations. To easily streamline the Part 11 validation process before FDA 21 CFR Part 11 inspection it is useful to ask the software vendor if validation documentation, tools or solutions are available. For instance, MasterControl, Inc., a developer of document control, quality management and product lifecycle software solutions, provides validation documentation, a validation toolkit, validation consultation, validation training and/or full-scale validation services.

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FDA 21 CFR Part 11 Inspections - MasterControl's Suite is Compliant, Connected, and Complete

MasterControl suite distinguishes itself from other 21 CFR Part 11 training software providers by keeping companies compliant, connected, and complete.

  • Compliant: MasterControl believes that compliance with 21 CFR Part 11 training requirements is a state, not an event. MasterControl optimizes quality and business processes for FDA 21 CFR Part 11 inspections by fostering efficiency and lowering compliance costs. Connected: MasterControl 21 CFR Part 11 training software solutions are integrated to effectively connect people with data and processes so life science companies can see the big picture across their enterprise.
  • Complete: MasterControl believes that 21 CFR Part 11 training initiatives must be integrated into an organization's corporate culture. Along with a web-based platform, MasterControl offers a line of validation products and services to allow continuous validation.

MasterControl FDA 21 CFR Part 11 Inspection Validation Services and Solutions

To achieve FDA 21 CFR Part 11 inspection validation, consider the services and solutions that MasterControl provides. These services include quick-start validation documentation packages which include IQ (Installation Qualification) and OQ (Operational Qualification) validation scripts that have been pre-written. Support services for IQ and OQ validation can also be provided.

MasterControl also provides a written validation introduction for Regulatory Affairs managers and FDA 21 CFR Part 11 inspection. The documentation outlines duties that need to be performed during the Part 11 validation process and allows RA managers to understand the scope and commitment and meeting GAMP (Good Automated Manufacturing Practices) compliant computer systems validation. MasterControl also provides a Validation Toolkit for those professionals with little experience in validation. It's likely that these professionals will appreciate more than IQ, OQ protocols and a validation introduction. They can therefore take advantage of the FDA 21 CFR Part 11 inspection validation Toolkit package which assists key personnel in completing validation requirements including PQ test protocols.

For More Information on FDA 21 CFR Part 11 Inspections

To learn more about MasterControl quality management systems and FDA 21 CFR Part 11 inspection solutions and services, please feel free to contact a MasterControl representative.