Good Manufacturing Practice (GMP) Quality

How to Assure that your System Complies to the Requirements for Good Manufacturing Practice (GMP) Quality

Much of analytical chemistry in a GMP environment relies on complete compliance with GMP and additional practices stipulated by the FDA, ISO, and other regulatory and quality organizations. Good manufacturing practice (GMP) quality can become extremely difficult to manage and require excessive amounts of time when utilizing manual or hybrid procedures.

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The MasterControl Suite™ Helps Companies Achieve GMP Quality Easily and Quickly

The MasterControl Suite offers the following integrated applications to help companies achieve and maintain good manufacturing practice quality:

• MasterControl Documents™ automates the entire GMP quality lifecycle of all documents-based processes, including task assignment, routing, follow-up, tracking, escalation, review, and document/process approval.
• MasterControl Training™ automates assignment and monitoring of training tasks and (with the MasterControl Exams add-on) the grading of online exams. This helps companies achieve good manufacturing practice quality certification by meeting the guidelines associated with employee competence.

  The good manufacturing practice quality software allows sequencing of training courses, so that after a prerequisite course is completed, the next course is automatically launched. The software also provides a group sign-off feature for verifying the training of large groups of employees. Training management can be integrated with the rest of the quality system, so that any change to a document or process that warrants new training automatically invokes training tasks upon approval of the change.

• MasterControl CAPA™ connects with different GMP quality subsystems to track incidents, from event identification and management to CAPA if necessary to resolve the event.
• MasterControl Change Control™ streamlines the change control process for faster turnaround. The software offers a 'best practice' form that incorporates current requirements from good manufacturing practice quality guidelines.
• MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling nonconforming materials and finished products to ensure compliance with GMP guidelines, so that companies can easily achieve GMP quality.

For More Information on Good Manufacturing Practice Quality

For more information about GMP quality, and how our software can help your company meet current good manufacturing practices, please feel free to contact a MasterControl representative.