ASTM-E2066 2007

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E2066-00(2007) Standard Guide for Validation of Laboratory Information Management Systems

Published By	Publication Date	Number of Pages
ASTM	2007	25

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Categories: 35.240.80 - IT applications in health care technology, ASTM

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Description

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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PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology
3	Significance and Use The LIMS Life Cycle and the Validation Process
4	FIG. 1
5	LIMS Vendor Assessment/Audit
6	FIG. 2
8	Validation of LIMS Installed at Customer Site
9	Validation Plan Design Test Protocol Design
11	LIMS Operation
12	Documentation
15	The Quality Assurance Unit (QAU) Management’s Role
16	X1. VENDOR ASSESSMENT INFORMATION FIG. X1.1
17	FIG. X1.1
18	X2. VALIDATION PLAN FIG. X2.1
19	X3. TEST PROTOCOL DESIGN EXAMPLE FIG. X3.1
20	X4. QUALIFICATION REPORT FIG. X4.1
21	X5. LIMS VALIDATION ERROR REPORT ( FIG. X5.1
22	X6. CHANGE REQUEST/PROBLEM LOG ( FIG. X6.1
23	FIG. X6.1
24	FIG. X6.1
25	REFERENCES

Additional information

Standard Title	E2066-00(2007) Standard Guide for Validation of Laboratory Information Management Systems
Published Code	ASTM
Publication Date	2007
Pages Count	25
ICS Codes	35.240.80 - IT applications in health care technology

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ASTM-E2066 2007

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