ASTM E 2066 : 2000 : R2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Standard Guide for Validation of Laboratory Information Management Systems (Withdrawn 2015)
Hardcopy , PDF
10-09-2015
English
03-01-2007
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 03.06, 2015 Define an approach to the validation process for a Laboratory Information Management System (LIMS).
| Committee |
E 13
|
| DocumentType |
Guide
|
| Pages |
26
|
| ProductNote |
Reconfirmed 2007
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Withdrawn
|
| Supersedes |
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.
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