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Labcompliance News, May 2003

May 6, 2002

Paul Motise Gives His View on Part 11 Guidance Documents

While the number of attendees at computer validation and part11 conferences seems to go down because of market saturation, not so at IVT's conference in Washington/Airlington on April 22-25. With 320 people it had one of highest attendances ever in the history of commercial compliance conferences. One the reason was the innovative program structure with many parallel workshop and interactive discussion sessions. An other reason was participation of Paul Motise from the US FDA. He gave an update on FDA's part 11 validation guidance. Key discussion points have been: most frequently found deviations during inspections, status and future of part 11 guidances, what validation documents are expected to be developed and by whom, what is 'proper' hardware and software installation, testing loads of networks, boundary testing, live-testing, code inspections, vendor assessment, change control, regression analysis and testing, validation of macros and internet validation.

May 6, 2002

Technologies Supporting Security Requirements in Part 11

Computer security is used to regulate and record access to computer resources as well as access and manage records residing in a computer. pharmaceutical Technology has published two articles on this topic. Part one of this two article series from Orlando Lopez reviews FDA's requirements and current technologies. Part two reviews how current technologies apply to the security requirements contained in 21 CFR Part 11.

May 6, 2002

Qualification of Networks and Validation of Macros&Spreadsheets Calculations Hot Topics

"Validation of laboratory computers according to the part 11 validation guidance", "Using macros&spreadsheet calculations in a regulated environment" and "Qualification of network infrastructure and validation of networked systems" have been amongst the hottest topics at IVT's conference on CSV and ERES. All topics have been discussed in workshops or as part of Interactive Discussion sessions by Dr. Ludwig Huber. Those of you who could not attend can order interactive video presentations on CD and other material presented at the conference. For laboratory computers click here, for Macros&Spreadsheets click here, and for Networks click here

May 6, 2002

FDA's Part 11 Industry Guidance on Time Stamps

The guidance has been released as draft in March 2002. It requires procedures and controls to ensure time stamps are accurate and reliable. Computers on a network should automatically synchronize their clocks with that of designated network computer. Computers not on a network should have their clock synchronized to a recognized standard clock and should be periodically verified against the standard clock. other requirements are that companies should be able to detect inappropriate changes to the computer clocks. Employees should be made ware that unauthorized changes to clock settings are serious and unacceptable actions (see also the Interview with P.Motise on www.labcompliance.com/conferences/august99.htm). FDA's previous interpretation that local time should be recorded has been revised. now any time can be used as long as it is clear what time zone reference has been used.

May 6, 2002

FDA Warning Letterer Requests Pre-audit and Certification Through Outside auditor

Citations in the Warning Letter included missing or incomplete documentation of corrective and preventative actions as required by the company's preventive and corrective action procedure, incomplete process validation, no annual re-validation as required the company's SOP and after after changes. Towards the end of the Warning Letter the FDA requested certification by an outside expert consultant that he/she has conducted an audit of the company's establishment’s manufacturing and quality assurance systems. Labcompliance user club members can pre-study keywords and extracts and download warning letters. To preview extracts and ordering users club membership, click here and select W-074.