Medical industries

The medical industry includes businesses that produce pharmaceuticals, medical equipment, implants etc. Different businesses have different requirements on traceability but most of them share the fact that they in one way or another are regulated by the FDA (Food and Drug Administration. Up to a few years ago these rigorous requirements set up by the FDA forced many businesses to rely on pen and paper for their quality analyses.

Obviously there are great profits to be made, both in time and in making the analysis clearer by implementing a quality assurance system.  But this has to be done with care since the digital protocols and digital signatures must live up to the traceability standard set up by the FDA. In the regulation 21 CFR Part 11 the FDA states how digital records and digital signatures should be handled by the medical industries in order to leave the pen and paper behind.

Considering that we have been tested and approved by several stand-alone audits we can guarantee that our product lives up to your traceability requirements mentioned above.