CFR Part 11 applies to drug manufacturers, biotech companies, medical device manufacturers, contract research organizations, and several other FDA-regulated industries (such as food and beverage manufacturing) – some companies use Part 11 as a guide to assure that they are utilizing good processes for managing their electronic training records and other documents.
Accurate record generation means that records entered into the system must be completely retrievable without unexpected alteration or unrecorded changes. There are many ways InterTech products and equipment can help Medical Device Users towards 21CFR11 compliance. Accurate record generation means that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes.
InterTech Instrumentation and Application expertise provides turnkey customized solution for leak testing applications that guarantees single source Gauge R & R gauge compliance capability, guarantying the speed and reliability of the measurement values acquired by the system. In audit and production applications IDC instrumentation testing results determine quality, safety, strength, efficacy, or purity related to product release and product quality.
Contact IDC for application details.