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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Standard Guide for Validation of Laboratory Information Management Systems (Withdrawn 2015)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
09-10-2015
English
01-03-2007
Important note : Users cannot be edited or removed once added to your Multi user PDF.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Withdrawn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.
| ASTM E 2538 : 2006 : R2011 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020) |
| ASTM E 2473 : 2005 : R2011 | Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record (Withdrawn 2020) |
| ISO 10011-3:1991 | Guidelines for auditing quality systems Part 3: Management of audit programmes |
| IEEE 1074-2006 | IEEE Standard for Developing a Software Project Life Cycle Process |
| IEEE 1008-1987 | IEEE Standard for Software Unit Testing |
| IEEE 610 : 1991 | COMPUTER DICTIONARY - A COMPILATION OF IEEE STANDARD COMPUTER GLOSSARIES |
| IEEE 828-2012 | IEEE Standard for Configuration Management in Systems and Software Engineering |
| ISO 10011-1:1990 | Guidelines for auditing quality systems Part 1: Auditing |
| IEEE 830-1998 | IEEE Recommended Practice for Software Requirements Specifications |
| IEEE 729-1983 | IEEE Standard Glossary of Software Engineering Terminology |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 10005:2005 | Quality management systems Guidelines for quality plans |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 9004-2:1991 | Quality management and quality system elements Part 2: Guidelines for services |
| ASTM E 1639 : 2001 | Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (Withdrawn 2002) |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 9001:2015 | Quality management systems — Requirements |
| IEEE 1012-2012 | IEEE Standard for System and Software Verification and Validation |
| IEEE 1063-2001 | IEEE Standard for Software User Documentation |
| ISO 9003:1994 | Quality systems Model for quality assurance in final inspection and test |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| IEEE 1058.1-1987 | IEEE Standard for Software Project Management Plans |
| IEEE 829-2008 | IEEE Standard for Software and System Test Documentation |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
| ASTM E 919 : 1996 | Specification for Software Documentation for a Computerized System (Withdrawn 2000) |
| ISO 9000-3:1997 | Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software |
| ISO 10011-2:1991 | Guidelines for auditing quality systems — Part 2: Qualification criteria for quality systems auditors |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.