PIL&M Inc.

Expert Computer system validation (GxP | GAMP5) – Engineering Consultants

Expert Computer system validation (GxP | GAMP5) – Engineering Consultants


Engineering-Consultant for Biotech & Medical Device Companies
Oven Thermal Mapping

We are Expert Computer System Validation (GxP|GAMP5) engineering consultants. We frequently execute validation (GxP|GAMP5) projects on a fixed price basis or offer our experienced Validation (GxP|GAMP5) Consultants or Validation (GxP|GAMP5) Engineers at an hourly rate basis that work out of our office or on your site.

Free Consultation Service
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We offer validation services in equipment/computer-system, process validation and including test method validation. We realized that the quality of equipment or process is of utmost importance not only to the governing regulatory bodies but also to the overall success of the organization. Through our internal validation guidance documents and your SOPs we qualify your part/item by confirming that it; functions as designed/intended, can perform to desired/selected parameters, has minimal impact to the environment and does not pose any risk to the user. Our approach to every single validation is as follows:

Master Validation Plan

  • FAT – Factory Acceptance Test 
  • SAT – Site Acceptance Test
  • Initial Screening 
  • Validation Plan
  • PSP – Part Specification Program Qualification Plan
  • URS – User Requirement Specification 
  • FS – Functional Specification

Traceability Matrix 

  • Validation Protocol 
  • Validation Report 
  • Computer System Hazard & Risk Management 
  • BFU – Build Factory Utility
  • EH&S Safety Report
  • 3rd Party Electrical Verification Report 
  • MSA – Measurement System Analysis  Report 
  • Correlation/Equivalence Study Report

Configuration Specification 

  • Software Configuration

Test 

  • Training 
  • IQ – Installation Qualification
  • OQ – Operational Qualification
  • PQ – Performance | Process Qualification

Review 

  • Document Submission/Filing 
  • Change Control
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