11605 South Alden Street, Olathe, KS 66062                 Phone: +1 913 681 9261

 

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Good Manufacturing Practice

Documentation Deliverables

According to the FDA, "cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations."

 

Your plant’s automation system performance is critical to meeting cGMP requirements.  Just as important is documenting that performance from initial design through FAT and SAT testing and validation of installed operation.

 

GCS has a consistent track record of delivering compliant process control systems and the necessary cGMP documentation.  We work closely with our customers to ensure that both cGMP automation system requirements and internal SOPs are followed.

 

 

 

 

 

 

 

For regulated industries, system reliability and integrity are a necessity, not an option.  Operational validation of your process control system must be the goal from the start.  GCS knows how to select hardware, develop software, and integrate their functionality to produce strictly repeatable results.  We can implement 21CFR Part 11 along with automatic, accurate batch logging to document product compliance.

 

GCS staff have hands-on experience with critical batch and continuous process applications, packaging, and industrial networking in the regulated environment.  Good Automated Manufacturing Practices (GAMP®) are applied throughout the system lifecycle, from conceptual design and user requirements definition to qualification and validation.

 

Along with quality, they build production efficiency and resource cost savings into your delivered system.  Application of our GCS Process Intelligence™ framework for system development directly benefits your bottom line.  That’s another reason why GCS is your supplier of choice for a wide variety of applications.

 

 

FDA Regulated Industries

Pharmaceutical Applications