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Labcompliance News, October 2002

October 26, 2002

Examples for Requirement Specifications and Functional Testing


Labcompliance has developed real life examples for for User Requirement Specifications and Functional Testing. Test cases are linked to pre-numbered requirement specifications. The test script includes 12 test cases for normal, boundary and out of range data with acceptance criteria and actual results The examples also include a test schedule and test summary sheet. User club members can download the examples.

October 25, 2002

Network Infrastructure Qualification & System Validation Conference

320 Professionals mainly from IT and QA departments of pharmaceutical and medical device industry attended the IVT conference Network Infrastructure Qualification & System Validation in Philadelphia on Oct 7-9. The conference started with a workshop on "Configuration Management and Change Control for IT Infrastructure" with course Leader Jerry Anderson of Amgen. A total of 12 tutorials followed with speakers such as Martin Browning from EduQuest, Anthonio Fiorito and Thomas Quinn from the Hollis Group, Yolanda Williams from Bayer, Jeff O'Neil from Alpha Therapeutic Corporation, Dennis Marquis from BMS and Warren Campbell from CDI Engineering Group. Ludwig Huber of Agilent gave two presentations, one was on "Validation of networked systems", the other one on "Using the Internet in a regulated environment". Both presentations can be downloaded from the Users Club website (NW-002 and NW-003). Most frequent discussions have been on what and how much to do for network infrastructure devices like switches, routers and hubs. Suggestions ranged from simple device documentation to full multi-weeks tests of all specifications. The Labcompliance Network Quality Package gives good advice and a practical approach on what to do. For a summary click here.

Ludwig Huber's presentation "Validation of Applications Running on a Qualified Network" has been ranked as the number 1 conference paper.  

October 7, 2002

Part 11 Checklist for Analytical Laboratories

Labcompliance has developed an extensive checklist for part 11. It can be used to assess a laboratory for part 11 compliance and in preparation for internal audits and FDA inspections. It is recommended to use it as starting point for further customization. User club members can download the checklist from the part 11 site under R-043 .

October 7, 2002

New Contingency Planning Guide for Information Technology Systems

Information technology (IT) and automated information systems are vital elements in most business processes. Because these IT resources are so essential to an organization’s success, it is critical that the services provided by these systems be able to operate effectively without excessive interruption. Contingency planning supports this requirement by establishing thorough plans and procedures and technical measures to enable a system to be recovered quickly and effectively following a service disruption or disaster. Contingency planning is also a regulatory requirement and has been subject to FDA inspections (see W-082).
The Information Technology Laboratory of the National Institute of Standards and Technology has published free 94 page "Contingency Planning Guide For Information Technology Systems". It is applicable for desktop and portable computers, servers, web sites, LANs, WANs, distributed systems and for mainframe systems. The guidance presented should be considered during every stage of contingency planning, starting with the conceptualization of contingency planning efforts through plan maintenance and disposal of the contingency plan. If used as a planning management tool throughout the contingency planning process, the document and its appendices should provide users with time- and cost-saving practices.
The guidance also provides a structured approach to aid planners in developing cost-effective solutions that accurately reflect their IT requirements and integrate contingency planning principles into all aspects of IT operations. Most valuable are the Appendices with contingency Plan Templates.

October 6, 2002

New FDA Initiative To Enhance Pharmaceutical Good Manufacturing Practices

The Food and Drug Administration (FDA) announced that it is undertaking a significant new initiative to enhance the regulation of pharmaceutical manufacturing and product quality and to bring a 21st century focus to this FDA responsibility. The initiative focuses on FDA's current good manufacturing practice (cGMP) program and will cover veterinary and human drugs, including human biological drug products such as vaccines. This initiative is designed to improve public health promotion and protection by focusing on three major goals that will augment FDA's pharmaceutical product quality assurance programs across the board. The first goal will be to enhance the focus of the agency's cGMP requirements more squarely on potential risks to public health, by providing additional regulatory attention and agency resources on those aspects of manufacturing that pose the greatest potential risk. The second goal will be to help ensure that FDA's essential work in establishing and enforcing pharmaceutical product quality standards does not impede innovation and the introduction of new manufacturing technologies in the pharmaceutical industry. The third goal will be enhancing the consistency and predictability of FDA's approach to assuring production quality and safety among the FDA's centers and field components.

Oct 5, 2002

Macros&Spreadsheets Calculations and Qualification of Networks Hot Topics

The IVT conference on ERES and computer validation in Dublin, Ireland, was a big success. The four day conference was attended by more than 250 people. Attendees liked the interactive discussion and workshop style together with the availability of pre-study, handout and reference material on the Internet for some of the sessions. "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 the conference. All topics have been discussed in workshops or as part of Interactive discussion sessions by Dr. Ludwig Huber. It rarely happens that attendees sent feedback after the conference, but Kevin McNally, IT Manager of Fujisawa Ireland Ltd
did: "I have to say that I learned more with attending your (Ludwig Huber's) talks this week than I have learned in the last 4 years working in a regulated environment. If only all people spoke as clearly and logically as yourself then perhaps a lot of the confusion and fear would not exist anymore". Those of you who could not attend can order interactive video presentations on CD and other material presented at the conference. For Macros&Spreadsheets click here, and for Networks click here