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Labcompliance News, June 2002

June 16, 2002

Boost Efficiency Through E-Records/Signatures Systems

It seems that investments in automated e-records/signature system can pay back when well implemented. This article appeared in FDA News on June 14 and highlights cost savings in a laboratory. Reference http://www.fdanews.com


Part 11's tough electronic compliance standards helped inspire AstraZeneca to launch a Site Excellence Program (SEP) in the Spring of 2000 that has significantly reduced product cycle time and error rates in its lab, a company official said at an industry conference June13.

Prior to the launch of the program, testing cycle time in the lab was about 23 days, with another 13 days for review, Senior Manager of QA Analytical Michael Stroz said. Post-SEP, those figures have been cut to seven days and two days, respectively, he said.

Stroz wouldn't discuss specific financial costs of the program, but noted that the figure was "insignificant" when compared to the cost savings in overall cycle time reduction and more efficient lab usage. He said it costs AstraZeneca about $250,000 per day to run its lab.

"Shaving just a day or two off" the amount of lab days required to perform tasks represents considerable savings, Stroz told attendees of the American Association of Pharmaceutical Scientists "Paperless Laboratory" conference in Arlington, Va."

A new book and CD entitled "Validation of Computerized Analytical and Networked Systems" has chapters on "Implementing Part 11 in Laboratories" and "Operational Compliance of Legacy Systems".
Very much in line to this topic are also an article series published in Biopharm on "Implementing E-records/Signatures in Analytical Laboratories" and a presentation presented at the conference LIMS2002 in June with the title: "Increasing Efficiency and Compliance through Paperless Laboratory Operations". Labcompliance Users Club Members can download the article series and the presentation from the part 11 UsersClub website. For preview and registration, click here

June 16, 2002

Risk Analysis and Risk Assessment Becoming more Important

It seems that it becomes more and more difficult to comply with all requirements s documented in regulations and guidance documents. An example is the FDA Part 11 validation draft guidance. It suggests for Commercial, Off-The-Shelf Software End users should conduct functional testing of software that covers all functions of the program that the end user will use. Test conditions should include not only "normal" or "expected" values, but also stress conditions (such as a high number of users accessing a network at the same time). Test conditions should extend to boundary values, unexpected data entries, error conditions, reasonableness challenges (e.g., empty fields, and date outliers), branches, data flow, and combinations of inputs.

To do this type of testing "for all functions the enduser will use" is very time consuming. The recommendation is to limit testing to critical systems and functions using the concept of risk analysis and assessment. This recommendation also comes from the guide itself. "When you determine the appropriate extent of system validation, the factors you should consider include (but are not limited to) the following: The risk that the system poses to product safety, efficacy, and quality; note that product means the FDA regulated article (food, human or veterinary drug, biological product, medical device, or radiological product)" and "The risk that the system poses to data integrity, authenticity, and confidentiality".
The question is: what are the criteria for risk assessment? The SQA Computer Validation Initiative Committee (CVIC) of SQA has developed a document entitled: Risk Assessment/Validation Priority Setting It provides guidance to the Quality Assurance (QA) Professional to assist their organizations in evaluating the risk factors when assessing their approach to computer validation