scope:

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.