Product/Service

Validating Corporate Computer Systems, Good IT Practice for Pharmaceutical Manufacturers

Source: Interpharm Press, Inc.
Possibly the biggest challenge facing pharmaceutical manufactures today in terms of computer validation is how to deal
Possibly the biggest challenge facing pharmaceutical manufactures today in terms of computer validation is how to deal with large corporate systems. The magnitude of these systems means that the impact of noncompliance in terms of validation could bring a pharmaceutical manufacturer to its knees if a regulator orders a system not be used. Organizations cannot generally afford to run standby parallel systems, and new systems can take a year or more to institute. Validation must be right the first time. There is a lack of case study material reflecting real-life pharmaceutical industry experience of corporate computer systems. This book presents practical advice on validating corporate computer systems from industry experts.

Chapters include:

  • Paperless and Peopleless Plants: Trends in the Application of Computer Systems, Gert Moelgaard
  • Developing an Information System Strategy, Chris Reid, Norman Harris and Brian Ravenscroft
  • Regulatory Expectations, Heinrich Hambloch
  • IT Validation Policy, Heinrich Hambloch
  • Demonstrating GXP Compliance, Guy Wingate
  • Integrating Manufacturing Systems - A New Era in Production Control, Christopher Evans and David Stokes
  • Validating Enterprise Asset Management Systems, Chris Reid and Tony Richards
  • Validating Enterprise/Manufacturing Resource Planning Systems, Owen Salvage and Melanie Snelham
  • Validating Laboratory Information Management Systems, Christopher Evans
  • Validating Electronic Document Management Systems, Roger Dean and Richard Mitchell
  • Compliance for the Corporate Information Technology Infrastructure, Peter Wilks
  • Validating Local and Wide Area Networks, Nicola Signorile
  • Maintenance and Support of Validated IT Systems, Ema Koelman, Kees de Jong and Kees Piket
  • Auditing Suppliers of Standard Software Packages, Anton Dillinger, Robert Kampfmann and Torsten Wichmann
  • Auditing Software Integrators and Hardware Manufacturers, Howard Garston Smith
  • Practical Implications of Electronic Signatures and Records, David Selby
  • Concluding Remarks: Validation in the 21st Century, Guy Wingate

2000, Hardcover, 544 pages

Interpharm Press, Inc., 15 Inverness Way E., Englewood, CO 80112-5776. Tel: 303-662-9101; Fax: 303-754-3953.