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The FDA has defined current Good Manufacturing Practices for both device and drug manufacturers. These Good Manufacturing Practices dictate the
necessary measures that must be taken to ensure that manufacturing quality systems and processes are in place to consistently produce quality products.
As a result, manufacturers are able to produce a manufacturing certificate of compliance to accompany products manufactured.
The FDA’s Good Manufacturing Practices lie at the heart of quality and provide continual measures of quality that can uncover problems and
fluctuations as they occur and before the product is shipped. Camstar’s Enterprise Manufacturing Execution and Quality Solution provides electronic
manufacturing control and real-time quality checking. Companies that use Camstar’s Enterprise Manufacturing Execution and Quality System more easily
maintain compliance with good manufacturing practices – at a lower cost
The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably and efficiently, 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.
Fully 21 CFR Part 11 compliant, Camstar’s Manufacturing Execution
System (MES), InSite, provides the comprehensive enterprise technology
manufacturers need to maintain manufacturing 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 enables companies to maintain compliance with good manufacturing practices without the burden of paper and redundant
checks and reviews.
Learn more about how Camstar customers successfully implement a comprehensive compliance solution using InSite
Manufacturing Execution System
(MES).
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