How PC-Based Batch Technologies can Enhance Conformance with 21 CFR Part II in FDA Regulated Industries - ISA EXPO 1998

About

In March of 1997, the Food and Drug Administration (FDA) released 21 CFR Part II, the Final Rule on Electronic Records and Electronic Signatures. This ruling relates to the use of electronic systems as a means of recording and maintaining Good Manufacturing Practice (GMP) related activity and has a large impact on FDA regulated industries. This paper will review the FDA 21 CFR Part II Final Rule, describe the impact of this ruling on FDA regulated industries, and define the required components of PC-based batch systems to facilitate compliance.

- Downloadable files require Adobe Acrobat Reader.

Customers who bought this product also bought: Opportunities for FDA Regulated Industries - ISA 2001 Alternative Solution for SOP Guided Manual Procedures - ISA 2001 Manufacturing Execution Systems (MES) - The Glue That Connects Manufacturing to the Enterprise - ISA TECH 1997 Validation (GAMP, FDA,...) and S88 Standards for Batch and Recipe Management Systems - INTERKAMA 1999 Automation Solutions Digital Library (Online)