Medical Device and Pharmaceutical manufacturers produce products that improve and save lives every day. Products must be of the highest quality to meet customer demands for safety and efficacy. In addition, Medical Device and Pharmaceutical manufacturers must meet stringent government regulations and oversight while managing an increasingly global supply chain.
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.
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® validation is quick and easy using the existing scripts provided by our developers. These scripts 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.