PMID- 12553085
OWN - NLM
STAT- MEDLINE
DCOM- 20030411
LR  - 20191210
IS  - 1052-9411 (Print)
IS  - 1052-9411 (Linking)
VI  - 9
IP  - 3-4
DP  - 2001 Jul-Dec
TI  - Required steps for the validation of a Laboratory Information Management System.
PG  - 217-24
AB  - The task of managing laboratory data is not a new one. Over the past two decades, 
      the use of Laboratory Information Management Systems (LIMS) has revolutionized 
      how laboratories manage their data. A LIMS is more than software; it has become 
      the workhorse of the laboratory, encompassing laboratory work-flow combined with 
      user input, data collection, instrument integration, data analysis, user 
      notification, and delivery of information and reporting. Types of organizations 
      that utilize LIMS vary greatly from research laboratories to manufacturing 
      laboratories to environmental testing laboratories. Commercially-available LIMS 
      have been around since the 1980s. In addition, many laboratories have designed, 
      implemented, and maintained in-house LIMS. The heart of any LIMS is the software. 
      Like other laboratory systems, the LIMS software is subject to quality control 
      and quality assurance checks. In regulatory environments this associated QA/QC is 
      referred to as "system validation." The primary purpose of system validation is 
      to ensure that the software is performing in a manner for which it was designed. 
      For example, the system acceptance criteria should be established and tested 
      against quantifiable tasks to determine if the desired outcome has been achieved. 
      LIMS features, such as autoreporting, reproducibility, throughput, and accuracy 
      must be quantifiable and verifiable. System validation ensures that the entire 
      system has been properly tested, incorporates required controls, and maintains 
      and will continue to maintain data integrity. Laboratories must establish 
      protocols and standards for the validation process and associated documentation. 
      Although vendors of commercial LIMS perform initial internal system validations, 
      the system must be revalidated whenever the end user, vendor or third party adds 
      modifications or customizations to the LIMS. Currently, detailed guidance 
      regarding system validation of LIMS is not available to the user. The issue is 
      addressed in Good Automated Laboratory Practices (GALP) and National 
      Environmental Laboratory Accreditation Conference (NELAC) documents which 
      indicate specific requirements or recommendations for operational checks and 
      periodic testing; however, it is up to the laboratory to determine suitable 
      methods to accomplish these tasks. Proper validation of a LIMS will allow a 
      laboratory to comply with regulations and also provide comprehensive 
      documentation on the system that is necessary to troubleshoot future problems.
FAU - Turner, E
AU  - Turner E
AD  - USACE Washington Aqueduct, 5900 MacArthur Blvd. NW, Washington, DC 20016, USA. 
      Elizabeth.A.Turner@wad01.usace.army.mil
FAU - Bolton, J
AU  - Bolton J
LA  - eng
PT  - Journal Article
PT  - Validation Study
PL  - United States
TA  - Qual Assur
JT  - Quality assurance (San Diego, Calif.)
JID - 9214530
SB  - IM
MH  - Clinical Laboratory Information Systems/*standards
MH  - Data Collection/standards
MH  - *Environmental Monitoring
MH  - Humans
MH  - *Quality Control
MH  - Research Design/*standards
MH  - United States
MH  - United States Environmental Protection Agency
MH  - United States Food and Drug Administration
EDAT- 2003/01/30 04:00
MHDA- 2003/04/12 05:00
CRDT- 2003/01/30 04:00
PHST- 2003/01/30 04:00 [pubmed]
PHST- 2003/04/12 05:00 [medline]
PHST- 2003/01/30 04:00 [entrez]
AID - 10.1080/713844028 [doi]
PST - ppublish
SO  - Qual Assur. 2001 Jul-Dec;9(3-4):217-24. doi: 10.1080/713844028.