Difference between revisions of "Good Automated Laboratory Practices"
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The '''Good Automated Laboratory Practices''' ('''GALP''') are an [[United States Environmental Protection Agency|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book |author=Paszko, Christine; Paszko Turner; Elizabeth Turner |title=Laboratory Information Management Systems |chapter=Chapter 6: Regulatory Requirements |year=2001 |pages=59 |publisher=CRC Press |url=http://books.google.com/books?id=ycEqnzPl2lYC& | The '''Good Automated Laboratory Practices''' ('''GALP''') are an [[United States Environmental Protection Agency|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book |author=Paszko, Christine; Paszko Turner; Elizabeth Turner |title=Laboratory Information Management Systems |chapter=Chapter 6: Regulatory Requirements |year=2001 |pages=59 |publisher=CRC Press |url=http://books.google.com/books?id=ycEqnzPl2lYC |isbn=0824741412}}</ref> Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories. The GALP was based of six principles<ref name=GALPBook>{{cite book |author=Weinberg, Spelton & Sax, Inc. |title=GALP Regulatory Handbook |chapter=Chapter 1: Why GALPs??? |year=1994 |pages=2–9 |publisher=CRC Press |url=http://books.google.com/books?id=RfzlSKm581EC |isbn=1566700256}}</ref>: | ||
1. The system must provide a method of assuring the integrity of all entered data. | |||
2. The formulas and decision algorithms employed by the system must be accurate and appropriate. | |||
3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the control process. | |||
4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process. | |||
5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user procedures are not followed. | |||
6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access. | |||
==References== | ==References== | ||
<references /> | <references /> | ||
Revision as of 22:28, 25 February 2012
The Good Automated Laboratory Practices (GALP) are an U.S. EPA-based conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."[1] Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice (GLP) requirements to what they saw as a state of increasing automation in laboratories. The GALP was based of six principles[2]:
1. The system must provide a method of assuring the integrity of all entered data. 2. The formulas and decision algorithms employed by the system must be accurate and appropriate. 3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the control process. 4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process. 5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user procedures are not followed. 6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access.
References
- ↑ Paszko, Christine; Paszko Turner; Elizabeth Turner (2001). "Chapter 6: Regulatory Requirements". Laboratory Information Management Systems. CRC Press. pp. 59. ISBN 0824741412. http://books.google.com/books?id=ycEqnzPl2lYC.
- ↑ Weinberg, Spelton & Sax, Inc. (1994). "Chapter 1: Why GALPs???". GALP Regulatory Handbook. CRC Press. pp. 2–9. ISBN 1566700256. http://books.google.com/books?id=RfzlSKm581EC.
