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Labcompliance News, March 2004

March 22, 2004

New Book on Computer Systems Validation

This new book with the title :"Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies" has been authored and edited by Guy Wingate and published by Interpharm/CRC. On 1000 pages the book supplies comprehensive coverage of computer validation principles and how to put them into practice for GCPs, GLPs, GMPs, GDPs, and Medical Device regulations from around the world. It includes 24 case studies illustrating the practicalities of validating different types of computer systems supporting laboratories and manufacturing. For more information and ordering click here.

March 15, 2004

Spreadsheet Compliance at FDA

Spreadsheet Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Records generated with spreadsheets should comply with FDA's 21 CFR Part 11 when they can have a high impact on product quality. Three steps are important: 1) spreadsheets should be designed with data integrity and traceability in mind, 2) they should be validated and 3) access to spreadsheets and functions should be restricted to authorized users and well documented. You can learn on how to develop und spreadsheet applications such as Excelâ„¢ in a new audio on-line seminar. FDA's Dennis Cantellops will be there as guest speaker and answer questions. He is an author of FDA's 40 pages Laboratory Information Bulletin (LIB): Design and Validation of Spreadsheets. For more information: click here.

March 1, 2004

GAMP Good Practice Guides for the Validation of Lab Systems

The GAMP Guide for Validation of Automated Systems is recognized as industry standard for computer validation. It is also used as reference in EU and US FDA guidance documents, e.g., in FDA's Part 11 guidance on Scope and Applications. While this guide is an excellent framework for computer validation in general it is not specific enough for all applications, for example laboratories. On the other hand because of their criticality laboratory computers are right on target of FDA inspections. That's the reason why GAMP has developed a special guide for laboratory computers. Results will be presented by team members in a workshop at the Interphex in New York on March 18. The seven GAMP Categories, along with Risk Assessment processes, will be used to determine a rational validation strategy as to appropriately scale laboratory validation efforts. For more information and registration, click here. Key findings of the workshop and recommendations will be presented in an on-line audio seminar on April 22

March 1, 2004

Network Qualification and System Validation

The popular Network Quality Package from Labcompliance has been updated. New SOPs and templates, a model URS, software to check file transfer accuracy with validation protocols and the primer updated with the new scope of part 11, are just a few examples. For more information and ordering, click here.