Compliance Services

  • FDA FCR title 21 part 11
  • User Requirement Specifications
  • Software Functional Documents
  • Installation Qualifications
  • Operation Qualifications

C.D. Microsystems is proficient at the many documents and procedures required to comply with federal agencies such as the Food and Drug Administration.  We are experienced with the Pharmaceutical and Medical industries needs for compliance.

Many of our customers rely on C.D. Microsystems to assist them in preparation and execution of the required documents and procedures.  We have also developed code to handle compliance with the Food and drug administrations federal code of regulations title 21 part 11 procedures for electronic signatures.

We are currently involved in several large expansion projects for Bristol-Myers Squibb utilizing a combination of GE Fanuc PLC's and distributed controls systems (Mod300 and Advant by ABB, Delta V by Emerson).  This work has included not only programming, but development of the required documents and procedures required by the Pharmaceutical industry.

 

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