The team of ELI Validation Engineers and Project Managers can assist in meeting quality and regulatory requirements across all industries based on current ISO, GLP, GMP, and GAMP guidelines. Furthermore, the team has a broad range of experience covering virtually all pieces of Process Equipment, Software Systems, and Cleaning processes.

In addition, to calibration ELI can now provide your organization with:

  • Validation Project Management
  • Preparation of Validation Master Plans
  • Preparation of Validation Protocols (IQ, OQ, PQ) and Summary Reports
  • Execution of Validation Protocols
  • Troubleshooting, Repair, and Maintenance of Equipment
  • SOP development
  • Evaluation of 21 CFR Part 11 (Electronic Records and Signatures) compliance
  • Vendor or Quality System Auditing

A sampling of our areas of expertise:

  • Temperature Controlled Units (cold rooms, incubators, refrigerators, and freezers)
  • Classified Environments (Class 10,000 to Class 100,000 Clean Rooms)
  • Facility Supporting Utilities (USP-PW, WFI, Clean Steam, etc.)
  • Sterilization Cycle Development (Autoclaves and Fermentors)
  • Computer and Software Validation (SCADA, PLC, Customized Packages, Off the Shelf Packages)
  • Process and QC supporting equipment.