PREDICATE RULES.


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Predicate rules are the requirements that can be found in part 21 CFR Food 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. The most well-known FDA regulations are the GMP regulations.

The Compendium of Predicate Rules (CPR) has been put together to satisfy a requirement that has existed for some time now. It enables you to reference the correct cGMP identity for your requirement, when working with any of compliance documents, from the User Requirements Specification (URS) through the - VMP - DQ - IQ - OQ to the PQ, you will always be capable of the referencing the associated rule. It acts as an aide-mémoire and allows you to be correct and accurate every time. No more boxing around with requirement descriptions - reference your requirements exactly. A really essential tool for all compliance professionals.

It can be used in meetings , during general conversation and during telephone conversations. You first check the CPR to see what rules apply, then check out the rules in depth. You can always be sure that your documents are referenced to the correct GMP requirement.


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This graphic is a schematic presentation of predicate documentation and procedural requirements.


GLP, GMP, and GCP guidelines. These requirements are essential to Part 11 in that they provide the ground rules for management of electronic records produced in accordance with Part 11 guidelines.

USEFUL REFERENCES


21 CFR Part 11, has been a problem ever since it was introduced. However the maze it was originally applied to, has been somewhat clarified, in as much that we now know that it applies to regulatory required information. If you have to keep data under a predicate rule, and you hold it in an electronic format, then Part 11 applies.

If there is no FDA requirement that a particular record be created or retained, then 21 CFR Part 11 most likely does not apply to the record.



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Part 11, Electronic Records; Electronic Signatures,

Scope and Application issued August 2003 available at

 http://www.fda.gov/Cder/guidance/5667fnl.pdf

 

General Principles of Software Validation:

Staff issued January 2002 available at

 

Computerized Systems Used in Clinical Trials

Guidance Revision 1 dated September 2004 available at

http://www.fda.gov/cder/guidance/6032dft.pdf.

 

Computerized Systems Used in Clinical Trials

dated April 1999 available

at http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf

 

Off-The-Shelf Software Use in Medical Devices

dated September 1999 available at:

 http://www.fda.gov/cdrh/ode/guidance/585.html

 

CDER Electronic Submissions

guidances available at

http://www.fda.gov/cder/guidance/index.htm#electronic%20submissions

 

International Conference on Harmonization Guidance for Industry:

Good Clinical Practice Consolidated Guidance dated April 1996 available

at http://www.fda.gov/cder/guidance/959fnl.pdf


PREDICATE RULES.