Good laboratory practice data documentation

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

In a modem laboratory the general guidehnes encompassed in good laboratory practices require careful interpretation when apphed to a laboratory that relies heavily on automated documentation, data files, and electronic signatures 21 CFR part 11 provides that interpretation. 

Most definitions of raw data concentrate on paper and/or electronic records. A good, concise definition is found in the FIFRA Good Laboratory Practice document (1) " Raw data means... 

A9.5.2.3.4 High quality data are defined as data where the validity criteria for the test method applied are fulfilled and described, e.g. maintenance of constant exposure concentration oxygen and temperature variations, and documentation that steady-state conditions have been reached, etc. The experiment will be regarded as a high-quality study, if a proper description is provided (e.g. by Good Laboratory Practice (GLP)) allowing verification that validity criteria are fulfilled. In addition, an appropriate analytical method must be used to quantify the chemical and its toxic metabolites in the water and fish tissue (see section 1, Appendix III for fiirther details). 

THE CHALLENGE OF MAINTAINING AND RETRIEVING THE DOCUMENTATION AND RAW DATA REQUIRED FOR GOOD LABORATORY PRACTICE COMPLIANCE... 

In connection with the actual, experimental conduct of the study, it is the responsibility of the Study Director to ensure that all raw data generated are fully documented and recorded in compliance with the GLP Principles. For data recorded manually this entails ensuring that the data have been recorded promptly and accurately and in compliance with these Principles of Good Laboratory Practice if data are recorded electronically through the utilisation of a computerised system, the Study Director should ensure that (the) computerised systems used in the study have been validated , and are fit for use in the study. 

The means for obtaining high quality, cost effective analytical services are described. These services are essential for accurate and economical analysis with rapid turn around time. Good laboratory practices, including computerized sample tracking, instrument calibration, maintenance of equipment and written documentation of the analytical methods assure high quality of the analytical data. 

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