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JKS & Associates

168 Chandon
Laguna Niguel, CA 92677
Tel: 949/363-1229
Fax: 586/283-6309

E-mail: johnsuzuki@jksassociates.com

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Description:
Provides small and large manufacturers with cost-effective software consulting in requirements analysis and design, verification and validation, risk and hazard analysis, ISO 14971, software auditing, software testing, and FDA GMPs, especially with computer-controlled devices, manufacturing processes, and 21 CFR Part 11. The company provides assistance in documenting software activities and in software process improvement.

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