SIMCO Worldwide Service and Support for FDA Regulated Companies  

The Biotechnology industry is a SIMCO core competency.  SIMCO provides services and software to over 600 Biotechnology and Medical Device Manufacturers.  We are proud to count many industry leaders among our client base.

For biotechnology, and medical device manufacturers, quality, compliance and documentation are paramount.  SIMCO maintains GMP trained calibration technicians and offers the only calibration and maintenance software that is pre-validated and compliant with 21 CFR part 11 Electronic Records; Electronic Signatures and part 820 Quality System Regulation.  SIMCO's validation was conducted by CSS (Certified Compliance Solutions, Inc.) which is an ISO 13485 and FDA registered company training FDA investigators in software validation.

We are proactive in supporting our clients' evolving needs.  This starts with designing a solution uniquely suited to your needs and continues as we provide service and support, utilizing unique SIMCO documentation, information capture, capability, and program management software to drive improvement and quality program success.