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Manufacturing Regulatory Compliance

The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably and grow their business in an environment of increasing globalization and elevated product development costs. This is challenging enough in itself, but for Medical Device and Biotech Manufacturers, the task is even more daunting due to the additional burden of dealing with the various facets of compliance in manufacturing originating from the FDA, EPA and SEC among others.

Good Manufacturing Practices

The core mandate that guides FDA regulatory oversight is consumer safety. As a result, the FDA has defined current Good Manufacturing Practices for both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to consistently produce quality products. As a result, manufacturers seek to attain a manufacturing certificate of compliance.

Computer Software for Manufacturing Regulatory Compliance

The goal of meeting the challenge of manufacturing regulatory compliance is the establishment of a consistent “top down” strategy for ensuring compliance across the manufacturing enterprise. Camstar has responded to this need by creating computer software for manufacturing regulatory compliance – Enterprise Manufacturing Execution and Quality Systems that satisfy the needs of Medical Device and Biotechnology manufacturers for a comprehensive compliance solution.

Fully 21 CFR Part 11 compliant, Camstar’s Manufacturing Execution and Quality System, InSite, provides the comprehensive enterprise technology infrastructure manufacturers need to maintain regulatory compliance while dramatically reducing its associated costs and risks. InSite enables manufacturing business process automation by creating a paperless environment for the establishment, maintenance and management of regulatory compliant global manufacturing operations. InSite allows companies to more easily and cost-effectively maintain compliance with good manufacturing practices.