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Regulatory Compliance for Manufacturing

Definition.

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 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.

Article.

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.

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

Camstar’s Enterprise Platform for Advancing Product Quality helps global manufacturers deliver the highest quality products, on time, the first time, every time. By enabling real-time, enterprise visibility, enforcing manufacturing controls and feedback into product design, global compliance is a natural outcome.

Camstar’s Platform drives global risk-based compliance management by enabling operational excellence and making compliance with international regulatory and industry standards a natural by-product of efficient, high quality processes.

Camstar helps its customers achieve:

  • FDA Regulatory Compliance with 21 CFR Part 820, Parts 210/211 and 21 CFR Part 11 for electronic records and electronic signatures.
  • Compliance with international industry standards including ISO 9001, ISO 13485, IEC 61215 and IEC 61646
  • Enterprise alignment with Good Manufacturing Practices (GMP) and Guaranteed Performance Standards
  • Reduction in Audit Findings and risks associated with noncompliance

Learn more about how Camstar’s Manufacturing Execution System (MES) enables global compliance.

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