21 CFR Part 11 Compliance – IDC application know-how

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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.Med75 Leak tester

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.

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MD&M West Anaheim- InterTech MED75-COMBO instruments

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Find superior leak testing technology including MED75-COMBO instruments from InterTech Development Company at Dukane’s MD&M West booth 2835 in the Anaheim Convention Center, Anaheim, California, February 11-13, 2014.

This partnership between InterTech and Dukane Intelligent Assembly Solutions is a reflection of shared dedication to the highest standards in medical device manufacturing. Both companies have reputations for engineering quality through controllable, repeatable, reliable performance.

The objective is to validate your process, qualify every part and obtain FDA approval. Look for InterTech’s MED75-COMBO instruments at MD&M, and wherever quality management and traceability is an absolute requirement.

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