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Significance and Use
Validation is an important and mandatory activity for laboratories that fall under regulatory agency review. Such laboratories produce data upon which the government depends to enforce laws and make decisions in the public interest. Examples include data to support approval of new drugs, prove marketed drugs meet specifications, enforce environmental laws, and develop forensic evidence for trial. This also extends to LIMS used in environmental laboratories. In some cases these systems may need to be interoperable with CLIMS and computer-based patient records (CPR) for reporting environmental exposures and clinical laboratory testing for biologic measure of stressor exposure. The enormous financial, legal, and social impact of these decisions requires government and public confidence in laboratory data. To ensure this confidence, government agencies regularly review laboratories operating under their rules to confirm that they are producing valid data. Computer system validation is a part of this review. This guide is designed to aid users validating LIMS and incorporating the validation process into their LIMS life cycle.
Validation must provide evidence of testing, training, audit and review, management responsibility, design control, and document control, both during the development of the system and its operation life (2).
1.1 This guide describes an approach to the validation process for a Laboratory Information Management System (LIMS).
1.2 This guide is for validation of a commercial LIMS purchased from a vendor. The procedures may apply to other types of systems, but this guide makes no claim to address all issues for other types of systems. Further, in-house developed LIMS, that is, those developed by internal or external programmers specifically for an organization, can utilize this guide. It should be noted that there are a number of related software development issues that this guide does not address. Users who embark on developing a LIMS either internally or with external programmers also should consult the appropriate ASTM, ISO, and IEEE software development standards.
1.3 This guide is intended to educate individuals on LIMS validation, to provide standard terminology useful in discussions with independent validation consultants, and to provide guidance for development of validation plans, test plans, required standard operating procedures, and the final validation report.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E622 Guide for Developing Computerized Systems (Discontinued 2000)
E623 Guide for Developing Functional Requirements for Computerized Systems
E624 Guide for Developing Implemention Designs for Computerized Systems
E627 Guide for Documenting Computerized Systems (Discontinued 2000)
E919 Specification for Software Documentation for a Computerized System (Discontinued 2000)
E1013 Terminology Relating to Computerized Systems
E1384 Practice for Content and Structure of the Electronic Health Record (EHR)
E1578 Guide for Laboratory Information Management Systems (LIMS)
E1639 Guide for Functional Requirements of Clinical Laboratory Information Management Systems
ICS Number Code 35.240.80 (IT applications in health care technology)