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FDA.org
Winchester specialists work with the regulatory team to bring systems and procedures into compliance with major FDA regulations including 21 CFR Part 11, Sarbanes-Oxley, and HIPAA.
Need your Part 11 Compliance plan to be more than just a plan? Winchester can help turn your Part 11 Compliance Plan into more than just a plan. We've made it easy.
Winchester provides training and consulting assistance to the level your company needs. Winchester can help you write the requisite Standard Operating Procedure (SOPs) such that your electronic and manual systems are inextricably tied to one another. Winchester has helped several client companies develop their compliance plan and conduct compliance reviews of Lotus Notes-based applications.
Contact Winchester to receive a Part 11 Handbook. Written by Winchester CEO Michael Regentz, this book outlines the steps an organization should take to become Part 11 Compliant.
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