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Labcompliance News, October 2003

October 23, 2003

What are predicate rules and how can I get them?

In the FDA's new guidance for part 11 but also in presentations and discussions thw FDA frequently refers to predicate rules as the primary decision whether part 11 applies or not. If record is not required by a predicate rule, part 11 does not apply. So the questions frequently are: "What is a predicate rule", "Is there a clear definition by the FDA", "Is there a list of predicate rules?", and finally "Is there a website where I can download all predicate rules". FDA's Scott McIntire came up that a definition: Predicate rules are the requirements that can be found in part 21 CFR Foods and Drugs regulations. They are basically promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act". Predicate rules can be downloaded from the FDA website. Labcompliance has developed a very much complete list of predicate rules in the UsersClub Preview sections. User Club members have access to convenient and direct download.

October 23, 2003

New Version: Macro and Spreadsheet Quality Package

The popular Labcompliance package with all information on how to deal with Macros and Spreadsheets in GxP and Part11 environments has been significantly updated. New SOPs and templates, a new script to ensure and demonstrate record integrity, software to check file integrity 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.

October 16, 2003

Qualification of Data Centers

Data centers play a key role in network infrastructure and applications running on the network. Key components such as file servers, application servers and databases are located in the centers. They should be designed and built to accommodate network infrastructure and applications. They should also be secured against unauthorized access and equipment in the center should be qualified to ensure on-going operation in case of normal operation and contingency situations.

October 3, 2003

Ten Success Factors for Risk Management

Risk assessment and management is getting more and more important for the pharmaceutical industry. It helps to optimize your company resources, e.g., to optimize the extent of validation, and 'justified and documented' risk assessment has been suggested by the FDA to be used a criterion to implement 21 CFR Part 11. These ten recommendations should help to get your program started and make it successful right from the beginning.