MeasurLink & The Medical Industry
Medical Device and Pharmaceutical manufacturers must meet stringent government regulations and oversight while managing an increasingly global supply chain. MeasurLink keeps the medical industry operating at the highest standards and efficiency.
FDA Compliance
Part 11 applies to drug makers, medical device manufacturers, biotech and other FDA-regulated industries. It requires manufacturers implement controls including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data. MeasurLink implements strong support for these requirements. Some of the tools used in Part 11 Compliance are:
- Electronic signatures
- Audit trails
- Unique users and login credentials
- Software validation
Software Validation
The Medical Industry, like many others, is required to prove that the software they use performs as advertised. Software validation is a principal means of avoiding defects and resultant recalls related to software defects. MeasurLink can support FDA compliance by offering templates for Installation Qualification (IQ) and Operational Qualification (OQ).
MeasurLink validation is quick and easy using the existing documents provided by our developers. These documents are used by the end user to ensure the software meets their requirements. MeasurLink works on virtually all electronic Metrology equipment. By utilizing one data collection and SPC platform, the need to validate multiple software is eliminated.