Orderly Documentation Management During Startup

Topics:
Records and Document Management
Tags:
Biotechnology
Source:
Tefen

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Overview: Biotech startups do not always have adequate plans for GMP documentation. Key issues typically overlooked include resource requirements, routing pathways, approval procedures, and how the documentation plan relates to the overall project plan. This article provides guidelines, tools, and recommendations on managing GMP documentation requirements to support the startup of a biotech facility. The methodology is based on experience with biotech startups and includes extensive discussion of identification, prioritization, routing, and management of key documents such as validation protocols, standard operating procedures (SOPs), and batch records.

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Format: PDF | Size: 807KB | Date: Feb 2005 | Pages: 6

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