Good Automated Laboratory Practice GALP

Laboratory management must provide a method of assuring the integrity of all data. Communication, transfer, manipulation, and the storage/recall process all offer potential for data corruption. The demonstration of control necessitates the collection of evidence to prove that the system provides reasonable protection against data corruption. 

The formulas and decision algorithms employed by the software must be accurate and appropriate. Users cannot assume that the test or decision criteria are correct those formulas must be inspected and verified. 

A critical control element is the capability to track raw data entry, modification, and recording to the responsible person. This capability uses a password system or equivalent to identify the time, date, and person or persons entering, modifying, or recording data. 

Consistent and appropriate change controls, capable of tracking the software operations, are a vital element in the control process. All changes must follow carefully planned procedures, be properly documented, and, when appropriate, include acceptance testing. 

Procedures must be established and documented for all users to follow. Control of even the most carefully designed and implemented software will be thwarted if the user does not follow these procedures. This principle implies the development of clear directions and SOPs, the training of all users, and the availability of appropriate user support documentation. 

---

Procedures should be established and recorded to ensure that an acceptable quality level is associated with input data extraction and use, model execution and validation procedures. The procedures described by the EPA s Good Automated Laboratory Practices (GALP) should be considered, where applicable. 

Good Automated Laboratory Practice (GALP) was developed to establish guidelines for automated data management in laboratories that supply data to the EPA. 

---