LIMS Applications:
Quality/Validation

The following areas within the LIMSource provide information concerning quality and validation applications:

LIMS/Letter
LIMSzine
Library
Other Places of Interest
Standards/Guides

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LIMS/Letter

21st Century Process Management Using SPC-Based Manufacturing Analytics

New Food Regulations Affect LIMS

Using Electronic Signatures and Biometric Devices with a LIMS

Validation of LIMS: An Entrepreneurial Approach to Regulation

The Good Audit

No Simple Answers

Quality Assurance of Computer Systems

Validation Issues Update

LIMSzine

Lab Accreditation is All Over the Map

The Electronic John Hancock

Auditing a Client/Server LIMS Vendor

Documented Processes Improve Data Management

LIMS, TQM and ISO 9000: Are They Linked?

Library

ANSI/ASQC Q90/ISO 9000 Guidelines for Use by the Chemical and Process Industries

The Change Agent's Handbook: A Survival Guide for Quality Improvement Champions

The EU Directive Handbook

The GCP Harmonization Handbook

GLP Applications for Test Substance Control, Formulation, and Analysis

GLP/GMP Computer Procedures and Systems

Goldratt's Theory of Constraints: A Systems Approach to Continuous Improvement

Good Laboratory and Clinical Practices

A Handbook of SOPs for Good Clinical Practice

Implementing ISO 14001

International Medical Device Registration

The Interpharm Guide to FDA International Inspections

Interpharm Master Keyword Guide to US FDA Regulations 21 CFR

ISO 14000 Guide: The New Environmental Management Standards

ISO 9000 Guidelines for the Chemical and Process Industries, Second Edition

Laboratory Information Management Systems, Development and Implementation for a Quality Assurance Laboratory

Managing the Analytical Laboratory Plain and Simple

Medical Device LIMSource: Library: Bookshelf: Product Development Planning for Health Care Products Regulated by the FDAQuality Assurance Manual

Product Development Planning for Health Care Products Regulated by the FDA

Quality Assurance Principles for Analytical Laboratories

Quality Management for Government: A Guide to Federal, State and Local Implementation

Sterile Product Facility Design and Project Management

Total Improvement Management

Total Quality in Information Systems and Technology

Total Quality in Research and Development

Validation of Computerized Analytical Systems

Other Places of Interest

This area includes connections to the ASQC, ISO, NIST, NSSN and more.

Standards/Guides

Industry standards use a defined set of characteristics to ensure the consistent use of a measurement or methodology across a discipline, whether it is a standard for a screw thread or a standard for a software driver. There are several standards and guides applicable to the laboratory environment, including the following:

ASTM Standards
IEEE Standards
International Standards Organization (ISO) Standards
U.S. Environmental Protection Agency (EPA) Standards
- Good Laboratory Practices
- Good Automated Laboratory Practices
U.S. Food and Drug Administration (FDA) Standards
- Good Manufacturing Practices

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ASTM Standards
* E-622: Guide for Developing Computerized Systems
* E-623: Guide for Developing Functional Requirements for Computerized Systems
* E-624: Guide for Developing Implementation Designs for Computerized Systems
* E-627: Guide for Documenting Computerized Systems
* E-919: Specification for Software Documentation for a Computerized System
* E-1578: Guide For Laboratory Information Management Systems (LIMS)

The ASTM LIMS Guide describes computer systems used to manage laboratory information and covers LIMS ranging from small labroratories with simple requirements to large multi-site laboratories with complex requirements. This guide costs $26.00 or $23.40, depending on whether you are an ASTM member or not, and can be obtained from the ASTM by calling (610) 832-9585, or faxing (610) 832-9555, or emailing service@astm.org.

IEEE Standards

The Institute of Electrical and Electronic Engineers (IEEE) provides numerous standards for software engineering, testing, and quality assurance, including:

* 729: Glossary of Software Engineering Terminology
* 730.1: Standard for Software Quality Assurance Plans
* 730.2: Guide for Software Quality Assurance Plans
* 828: Standard for Software Configuration Management Plans
* 829: Standard for Software Testing Documentation
* 830: Guide for Software Test Documentation
* 1008: Standard for Software Unit Testing
* 1012: Standard for Software Verification and Validation Plans
* 1016: Recommended Practice for Software Design Descriptions
* 1028: Standard for Software Reviews and Audits
* 1042: Guide to Software Configuration Management
* 1058.1: Standard for software Project Management Plans
* 1063: Standard for Software User Documentation
* 1074: Standard for Developing Software Life Cycle Processes
* 1228: Standard for Software Safety Plans

The IEEE can be reached online at www.ieee.org.

International Standards Organization (ISO) Standards

* 9000 - Quality Management and Quality Assurance Standards - Guidelines for Selection and Use
* 9000-3 - Guidelines for Application of ISO 9001 to Development, Supply and Maintenance of Software
* 9001 - Quality Systems - Model for Quality Assurance in Design, Production Installation, and Servicing
* 9002 - Quality Systems - Model for Quality Assurance in Production and Installation
* 9003 - Quality Systems - Model for Quality Assurance in Final Inspection and Test
* 9004 - Quality Management and Quality System Elements - Guidelines
* 9004-2 - Quality Management and Quality System Elements, Part 2 Guidelines for Services
* 9004-4 - Guidelines for Quality Improvements
* 9004-5 - Guidelines for Quality Plans
* 9004-6 - Guidelines for Configuration Management
* 10011-1 - Guidelines for Auditing Quality Systems, Part 1 Auditing
* 10011-2 - Guidelines for Auditing Quality Systems, Part 2 Qualification Criteria for Auditors
* 10011-3 - Guidelines for Auditing Quality Systems, Part 3 Managing Audit Programs
* TickIT - A Guide to Software Quality Management System Construction and Certification to ISO 9001

Copies of the ISO standards can be obtained from the appropriate national standards bureau for your country, such as ANSI in the U.S. ISO provides a list of the names and addresses for these standards bureaus at their web site, http://www.iso.ch.

U.S. Environmental Protection Agency (EPA) Standards

The Good Laboratory Practices (GLPs) present standards of practice which are regulations that govern the management and conduct of most non-clinical laboratory studies submitted to the EPA's Office of Toxic Substances and its Office of Pesticide Programs. These regulations are found under 40 CFR part 160, Federal Register, Vol. 54, No. 158, and were published on August 17, 1989.

The Good Automated Laboratory Practices (GALPs), or 2185 - Good Automated Laboratory Practices, provide principles and guidance to regulations, and assist in ensuring data integrity during automated laboratory operations. The GALPs were originally issued in December 1990 by the Office of Information Resources Management (OIRM), an arm of the EPA. Because the GALPs describe benchmarks for assuring the reliability of laboratory data, they are designed to be adopted by laboratories that use or are planning to use automated data collection and management systems, most particularly Laboratory Information Management Systems (LIMS). The GALPs are closely aligned with the GLPs and include many of the GLP requirements. The publication is available online in PDF format at http://www.epa.gov/irmpoli8/archived/irm_galp/

U.S. Food and Drug Administration (FDA) Standards

The Good Manufacturing Practices (GMPs) are used by pharmaceutical, medical device, and food manufacturers to define minimum requirements for producing and testing products to ensure that only acceptable product is released to manufacturing and sold to the public. These regulations are found under 21 Code of Federal Regulations (CFR), part 210 for drugs, general; part 211 for finished pharmaceuticals; part 820 for medical devices; and, part 110 for processed foods. Under these regulations, any drug, medical device, or processed food marketed in the U.S. must first receive FDA approval and must be manufactured in accordance with the U.S. GMP regulations. For more information, surf the FDA web site at http://www.fda.gov