Validation of a GLP Laboratory

Problem Definition

A GLP laboratory within a large research establishment comprised of several laboratory systems that are used in GLP studies.  This project involved development of a master plan and the compliance infrastructure for the entire GLP organization.  It also involved development and implementation of life cycle deliverables for several laboratory systems. The validation effort had the following major stumbling blocks:

  • The GLP laboratory did not have a good compliance infrastructure as the department was small and relatively inexperienced.
  • The systems used were not 21 CFR Part 11 compliant.
  • The IT security of the systems was not up to required standards.

ValiMation’s Role

ValiMation took on the lead role for the compliance and validation for this project.  Some of the activities performed by ValiMation are described below:

Project Planning

The laboratory personnel did not have the expertise to plan the validation effort. ValiMation came up with a validation plan for the entire project. A GAP assessment was conducted by ValiMation, based on which most of the gaps were rectified.

Responsibilities provided included:

  • Analyzing the systems and developing an effective testing methodology.
  • Developing Master Plan for computerized systems
  • Developing Facility level policies and procedures (compliance infrastructure)
  • Developing Life cycle methodologies
  • Providing Part 11 services including GAP assessments
  • Providing and implementing several recommendations on IT security.
  • Providing Lab systems validation services including development of specifications, protocols and execution of protocols.
  • Training personnel in areas of compliance.

Systems

  • Applied Biosystems (ABI) Prism 7700 Sequence Detection System and 3100 Genetic Analyzers
  • ABI Prism® 3100 DNA Sequencing Analysis Software
  • ABI Prism® Sequencing Detection System for Processing PCR (Taqman) data
  • Oxford Molecular AssemblyLIGN®
  • Oxford Molecular MacVector
  • Molecular Devices SpectraMax 340PC Spectrophotometers
  • Reese Storage Monitoring System
  • Inventory Management & Data Processing Workstations

ValiMation's Impact - Our Unique Value Proposition   

  • Managed and planned the entire validation effort.
  • Educated personnel in areas of compliance.
  • Performed GAP assessments
  • Beefed up IT security of the Laboratory
Case StudyNagesh NamaValidation, GLP, Laboratory Systems, 21 CFR Part 11, Success StoryComment