CGMP

How to Assure that your System Complies to the Requirements for CGMP

The process of complying with the requirements of Current Good Manufacturing Practices -- or CGMP -- is considered by many FDA-regulated companies to be a time consuming and expensive ordeal. In fact, the opposite is true: not complying with CGMP can be a time consuming and expensive ordeal.

FDA's current regulations for CGMP are there to ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For well over a decade, MasterControl has led the quality management software industry in providing the products, training, and support that companies need to attain and sustain compliance, while increasing production.

Watch Videos How MasterControl Makes Your Job Easier (3:50) Using MasterControl for FDA Compliance (3:53)

Downloads

	White Paper: CDER Official Offers Tips on CGMP Inspections - Avoid FDA-483
	White Paper: FDA's Quality Systems Approach to Pharmaceutical CGMPs
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	Q&A: Medical Device Inspector Offers Advise on Inspection

The MasterControl Suite™ Ensures Compliance with the Guidelines for CGMP

• MasterControl Documents™ automates the entire lifecycle of all documents-based processes, including task assignment/routing, follow-up, tracking, escalation, review, and approval.
• MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams for CGMP compliance. The 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 will automatically invoke training tasks upon approval of the change.
• MasterControl CAPA™ connects with different quality subsystems to track incidents, following from problem identification through corrective action. A CAPA can automatically be launched from another form, allowing users to enter relevant data into the CAPA form itself.
• MasterControl Change Control™ streamlines the change control process for faster turnaround. It offers a best practice form that incorporates current requirements for GCP, GLP, and CGMP.
• MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of any nonconforming materials and finished products to ensure compliance with CGMP guidelines.

For More Information

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

Related Links:

• CGMP
• CGMP Training
• CGMP Software
• CGMP Auditing
• CGMP Consultancy
• FDA CGMP