Pharmaceutical products that come under the authority of the FDA often require validation in accordance with 21 Code of Federal Regulations Part 11 (21 CFR Part 11). All data and intervention in the system are documented so as to ensure that electronic documentation and electronic signatures meet the same safety standards as the documentation on paper.

A successful inspection by FDA confirmed that Gerresheimer Medical Plastic Systems is one of the top manufacturers in the international medical technology market both in terms of performance and quality. The audit covered the entire value added chain.

Gerresheimer Medical Plastic Systems takes care of certification in accordance with GMP and FDA guidelines as well as the compilation and submission of documentation of medical products and primary pharmaceutical packaging products (e. g. DMF Type III, EU-File).