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Simplify 21 CFR Part 11 Compliance Document

White Paper Published By: DocuSign
Published:  Mar 13, 2020
Type:  White Paper
Length:  20 pages

It is the nirvana that life sciences organizations have been chasing for the past 30 years. The time is finally now. A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. All parts of the product development cycle—clinical trial management, regulatory affairs, commercialization, and everywhere in between—have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to effectively manage transactions within an organization and to extend beyond its four walls to collaborative partners such as CROs, customers, and other suppliers.

Paper-intensive processes, completed by scanning documents or sending them out for handwritten signatures, are increasingly embedded in automated workflows and digital systems, therefore rendering these processes “almost” paperless. The challenge in this digital evolution was that historically there was not a technology available to meet all of the FDA regulatory requirements while also providing the trust, security, and operational uptime needed to support the holistic digital transaction. Now there is a platform available to meet this need: The DocuSign Agreement Cloud. Life science organizations regulated by the Food and Drug Administration (FDA) are required to follow the Code of Federal Regulations Title 21 Part 11. ‘Part 11’ applies to records in electronic form that are created, modified, maintained, archived, retrieved, transmitted or submitted, under any records requirements set forth by the FDA regulations/predicate rules.

Life science organizations face significant risks and penalties if found to be noncompliant. Indeed, failure to comply could lead to 483 observations or warning letters. Noncompliant organizations also risk delaying submissions to the FDA under the requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

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