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Labcompliance News, March 2000

March 21, 2000

PDA Technical Report on Supplier Audits

Audits of suppliers of software and computer systems can be a good tool to qualify a vendor. However, this is time consuming and expensive. According to a survey made by the PDA Supplier Management Task Force the average cost of a vendor audit is US$8,000 to 10,000 per audit for the client and the the supplier. One proposal is that a number of companies make joint audits and share the results with others. A similar approach of vendor audits done by different companies would lead to a wider acceptance of such a procedure. The PDA has developed a standardized audit process model and has licensed Audit Repository Center (ARC) to administer the program. The new PDA technical report #32 "Auditing Suppliers of Companies Providing Computer Products and Services for Regulated Pharmaceutical Operations" gives such guidelines on vendor audits. Training courses are offered to familiarize software vendors and auditors with the audit program and to acquaint pharmaceutical companies and audited suppliers with how they may use the program to best advantage in terms of reducing overall time and cost. For details and registration see the PDA website
http://www.pda.org

March 19, 2000

Free primer on GLP/GMP in Laboratories'

Agilent Technologies has developed a new 120 page primer on GLP and GMP in Analytical Laboratories written by Ludwig Huber. In part 1 readers get a basic understanding on GLP and GMP regulations and their impact on analytical labs. Part 2 deals with validation of equipment, computers and methods. This part also includes aspects of electronic records and signatures as required by FDA's 21 CFR Part 11. Part 3 gives advice on how a vendor can and should help to share the burden of compliance. Overall the primer helps to speed up validation and to increase confidence for FDA inspections.

March 17, 2000

 Article on data integrity and security for 21 CFR 11

Part 3.Ensuring Data Integrity of Electronic Records, W.Winter and L.Huber, published by BioPharm in March 2000.
The third installment of the series outlines the basis for the reliability and trustworthiness of electronic records: Data integrity and traceability. Recommendations are given to help analytical labs assess the data integrity measures in existing and new systems. The article also explains how data systems compliant with the requirements of 21 CFR Part 11 manage audit trail and document control, thus ensuring accountability and auditability of the respective records that were used to support a particular decision (e.g. release a certain production batch). Download draft version from LabCompliance User Club.