ASTM E2066-00
(Guide)Standard Guide for Validation of Laboratory Information Management Systems
Standard Guide for Validation of Laboratory Information Management Systems
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.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E 2066 – 00
Standard Guide for
Validation of Laboratory Information Management Systems
This standard is issued under the fixed designation E 2066; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope Laboratory Information Management Systems (CLIMS)
2.2 IEEE Standards:
1.1 This guide describes an approach to the validation
100 Standard Dictionary of Electric and Electronic Terms
process for a Laboratory Information Management System
610 Standard Glossaries of Computer-Related Terminology
(LIMS).
729 Glossary of Software Engineering Terminology
1.2 This guide is for validation of a commercial LIMS
730.1 Standard for Software Quality Assurance Plans
purchased from a vendor. The procedures may apply to other
730.2 Guide for Software Quality Assurance Plans
types of systems, but this guide makes no claim to address all
828 Standard for Software Configuration Management
issues for other types of systems. Further, in-house developed
Plans
LIMS,thatis,thosedevelopedbyinternalorexternalprogram-
829 Standard for Software Testing Documentation
mers specifically for an organization, can utilize this guide. It
830 Guide for Software Test Documentation
should be noted that there are a number of related software
1008 Standard for Software Unit Testing
developmentissuesthatthisguidedoesnotaddress.Userswho
1012 Standard for Software Verification and Validation
embarkondevelopingaLIMSeitherinternallyorwithexternal
Plans
programmers also should consult the appropriate ASTM, ISO,
1016 Recommended Practice for Software Design Descrip-
and IEEE software development standards.
tions
1.3 This guide is intended to educate individuals on LIMS
1028 Standard for Software Reviews and Audits
validation, to provide standard terminology useful in discus-
1042 Guide to Software Configuration Management
sions with independent validation consultants, and to provide
1058-1 Standard for Software Project Management Plans
guidance for development of validation plans, test plans,
1063 Standard for Software User Documentation
requiredstandardoperatingprocedures,andthefinalvalidation
1074 Standard for Developing Software Life Cycle Pro-
report.
cesses
2. Referenced Documents
1228 Standard for Software Safety Plans
2.3 ISO Standards:
2.1 ASTM Standards:
9000 Quality Management and Quality Assurance Stan-
E 622 Guide for Developing Computerized Systems
dards - Guidelines for Selection and Use
E 623 Guide for Developing Functional Requirements for
9000-3 Guidelines for Application of ISO 9001 to Devel-
Computerized Systems
opment, Supply, and Maintenance of Software
E 624 Guide for Developing Implementation Designs for
9001 Quality Systems—Model for Quality Assurance in
Computerized Systems
Design, Production, Installation, and Servicing
E 627 Guide for Documenting Computerized Systems
9002 Quality Systems—Model for Quality Assurance in
E 919 Specification for Software Documentation for a
Production and Installation
Computerized System
9003 Quality Systems—Model for Quality Assurance in
E 1013 Terminology Relating to Computerized Systems
Final Inspection and Test
E 1384 Guide for Content and Structure of the Electronic
9004 Quality Management and Quality System Elements—
Health Record (EHR)
Guidelines
E 1578 Guide for Laboratory Information Management
9004-2 Quality Management and Quality System Elements,
Systems (LIMS)
Part 2 Guidelines for Services
E 1639 Guide for Functional Requirements of Clinical
9004-4 Guidelines for Quality Improvements
This guide is under the jurisdiction of ASTM Committee E13 on Molecular
Spectroscopy and Chromatography and is the direct responsibility of Subcommittee
E13.15 on Analytical Data. Available from Institute of Electrical and Electronic Engineers, Inc., 445 Hoes
Current edition approved Jan. 10, 2000. Published March 2000. Lane, P. O. Box 1331, Piscataway, NJ 08855–1331.
2 5
Annual Book of ASTM Standards, Vol 14.01. Available from International Organization for Standardization, 1 rue de
Discontinued 1994; see 1993 Annual Book of ASTM Standards, Vol 14.01. Varembé, Case postale 56, CH-1211 Genevé 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2066–00
10005 Guidelines for Quality Plans that can acquire, analyze, report, store, manage data, and
process information in the laboratory.
10007 Guidelines for Configuration Management
3.1.9 LIMS data loading (configuration), n—the process of
10011-1 Guidelines for Auditing Quality Systems, Part 1
entering static data into appropriate data structures, such as
Auditing
tables or database records, to make a LIMS suitable for
10011-2 Guidelines for Auditing Quality Systems, Part 2
operation in a particular laboratory. This information may
Qualification Criteria for Auditors
include items like names and addresses of laboratory custom-
10011-3 Guidelines for Auditing Quality Systems, Part 3
ers, names of laboratory personnel, descriptions of tests per-
Managing Audit Programs
formed by the laboratory, specifications, calculations, tem-
8402 Quality Vocabulary
plates, or descriptions of LIMS reports, etc. In this process, no
2382 Data Processing Vocabulary
new functionality is added to the LIMS that was not originally
planned by the system designers. Addition of configuration
3. Terminology
data may affect the behavior of the system.
3.1 Definitions—This guide defines terminology used in the
3.1.10 LIMS tailoring, n—see LIMS data loading (configu-
validation of computerized systems. The standards listed in
ration).
Section 2 provide additional definitions that the reader may
3.1.11 operational qualification (OQ), n—documentedveri-
want to review before beginning their validation process.
fication that each unit or the entire system operates as intended
3.1.1 acceptance criteria, n—the specifications used to
throughout its full operating range.
accept or reject a computer system, application, function, or
3.1.12 quality assurance unit (QAU), n—the body of indi-
test action.
viduals responsible for design and interpretation of quality
3.1.2 change control, n—the process, authorities for, and
standards, such as validation procedures and processes (not
procedures to be used to manage changes made to a comput-
product testing).
erized system or a system’s data, or both. Change control is a
3.1.13 source code, n—a computer program expressed in
vital activity of the QualityAssurance (QA) program within an
human-readable form (programming language) that shall be
establishment and should be described clearly in the establish-
translated into machine-readable form (object code) before it
ment’s SOPs.
can be executed by the computer.
3.1.3 configuration management, n—a discipline applying
3.1.14 static testing, n—a structured review of the source
technical and administrative direction and surveillance to
code.
identify and document the functional and physical character-
3.1.15 stress testing, n—the running of test protocols de-
istics of a configured item, to control changes to those
signed to test the limits of LIMS functions.
characteristics, to record and report change implementation
3.1.16 test plan, n—see test protocol.
status, and to verify compliance with specified requirements.
3.1.17 test protocol, n—a written procedure describing a set
IEEE
of actions and their expected outcomes that when executed
3.1.4 customization, n—the process of adding new software
provides documentary evidence that specific functional re-
to or altering a LIMS so that it may perform functions not
quirements for the LIMS work as specified.
planned by the original system designers. This entails creating
3.1.18 validation, n—the process of establishing docu-
new software, compiling software modules, and linking mod-
mented evidence that provides a high degree of assurance that
ules to produce new executable programs. If done by the
a specific process, system, or item consistently meets its
vendor, it may be considered and validated as part of the
predetermined specifications or quality attributes.
vendor system. See related definition for “customized system”
3.1.19 validation plan, n—the document that identifies all
in Terminology E 1013.
systems and subsystems involved in a specific validation effort
3.1.5 delivered system, n—the LIMS, as initially supplied
andtheapproachbywhichtheywillbequalifiedandvalidated,
by the vendor before any static configuration data have been
including identification of responsibilities and expectations.
added. In some cases, the vendor may contract with the
3.1.20 validation team, n—the group of individuals respon-
laboratory to enter some configuration data on behalf of the
sible for the validation process. This team may consist of
laboratory, in which case the delivered system is still consid-
representatives of the laboratory, QAU, Management Informa-
ered to be the default system before such customer-specific
tion System (MIS) organizations, or outside consultants.
information has been added. When the vendor performs this
task, they are an agent of the laboratory, and the customer shall 3.1.21 vendor audit, n—an independent review and exami-
nation of system records and activities in order to test the
meet the on-site validation requirements in Section 7.
3.1.6 dynamic testing, n—the actual testing of various adequacy and effectiveness of data security and data integrity
procedures, to ensure compliance with established policy and
functions and procedures using the LIMS software while in
operation. operational procedures, and to recommend any necessary
changes. ANSI
3.1.7 installation qualification (IQ), n—documented verifi-
cationthatallkeyaspectsoftheinstallationadheretoapproved 3.1.22 vendor audit team, n—ateammadeupofindividuals
design intentions as defined in system specifications and that who are knowledgeable in computer system engineering,
manufacturers’ recommendations are suitably considered. auditing practices, computer system quality methods, regula-
3.1.8 LIMS, n—acronym for Laboratory Information Man- tory compliance, validation practices, business and legal poli-
agement System that refers to computer software and hardware ciesandprocedures(applicableonlytocomputerhardwareand
E2066–00
software procurement and related services). (1) a specific subgroup within the organization. It is recommended
3.1.23 version control, n—control of all associated software that the vendor audit team should include organizational
and document versions. This also includes all documents members from the QAU, MIS, and the laboratory (1).
associated with implementation, validation, or operation of a
5.2 Business Requirements Definition Phase—The business
LIMS.
unit, specifically the laboratory, shall contact the QAU to
determine current good manufacturing practices (cGMPs),
4. Significance and Use
good manufacturing practices (GMPs), good automated labo-
4.1 Validation is an important and mandatory activity for
ratory practices (GALPs), and other requirements that shall be
laboratories that fall under regulatory agency review. Such
addressed with this project. An initial selection of validation
laboratories produce data upon which the government depends
team members is made at this time.
to enforce laws and make decisions in the public interest.
5.3 Project Definition Phase—Final agreement and man-
Examplesincludedatatosupportapprovalofnewdrugs,prove
agement acceptance for all validation team members should be
marketed drugs meet specifications, enforce environmental
obtained. Because validation is complex and can take a long
laws, and develop forensic evidence for trial.This also extends
time, each team member should have the full support of their
to LIMS used in environmental laboratories. In some cases
management. It is critical that management understands and
these systems may need to be interoperable with CLIMS and
agrees to the time commitment for these individuals. Without
computer-based patient records (CPR) for reporting environ-
agreement from each member’s management chain, the prob-
mental exposures and clinical laboratory testing for biologic
ability for developing and validating the LIMS successfully
measure of stressor exposure. The enormous financial, legal,
will diminish. Once formed, the validation team can start to
and social impact of these decisions requires government and
address high-level issues such as the existence of corporate
publicconfidenceinlaboratory data.To ensure this confidence,
standard operation procedures (SOPs) needed for validation.
government agencies regularly review laboratories operating
Time constraints and inexperience of team members can be a
under their rules to confirm that they are producing valid data.
limiting factor in the validation process. This is when the team
Computer system validation is a part of this review. This guide
should identify outside consultants that may be needed in the
is designed to aid users validating LIMS and incorporating the
validation process and begin developing the validation plan.
validation process into their LIMS life cycle.
Appropriate training of validation team members also should
4.2 Validation must provide evidence of testing, training,
be carried out during this phase of the LIMS life cycle.
audit and review, management responsibility, design control,
5.4 Model of Current State of Laboratory Practice—The
and document control, both during the development of the
validation team typically is not part of this process.
system and its operation life (2).
5.5 Model of Future State of Laboratory Practices—The
validation team typically is not part of this process.
5. The LIMS Life Cycle and the Validation Process
5.6 Functional Requirements Development Phase—The
5.1 The process of validation should start at the beginning
validation team should work with the group responsible for
of the LIMS life cycle as defined in Guide E 1578. Adding
developing functional requirements. At this time the team can
validation to the end of the LIMS implementation could add
also begin to develop and revise, as necessary, a high-level
from three to twelve months to the LIMS project. Further,
draft of the organization’s validation plan for this project. The
adding validation to the end of the process would prevent the
validation team may want to begin developing the high-level
organization from using the LIMS during validation. Fig. 1
test protocols during this phase. Further this activity begins to
representspointswhere
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.