Validation Services

Process and Water can prepare and execute qualification protocols for pharmaceutical (purified water) systems. Our in-depth knowledge of these systems, along with our knowledge of industry standards, practices and regulatory requirements, allows us to offer a complete and accurate validation package.

Installation Qualification (IQ) involves field verification that the equipment has been installed properly and in accordance with design specifications and manufacturer’s recommendations. IQs also verify the receipt of completed documentation, the existence of equipment Standard Operating Procedures (SOP) and preventive maintenance programs. The IQ protocol documents the installation verification of all components of the equipment and its control system. Our IQ protocols include, but are not limited to, the following verifications:

  • Purified Water system IQ Protocol
  • Documentation Verification
  • Manuals Verification
  • As-Built Drawings Verification
  • Standard Operating Procedures (SOP) Verification
  • Instrument Verification
  • Valve Verification
  • Piping Installation Verification
  • Utilities Verification
  • Major Component Verification (ASME pressure vessels, heat exchangers, pumps, motors, etc.)
  • Control System and Panel Verification
  • Input/Output (I/O) Loop Verification

Operational Qualification (OQ) involves field verification that the equipment is capable of operating in accordance with design specifications and the client’s requirements. Our OQs verify equipment capability, operating ranges and all operation modes of the equipment (PLC verification). The OQ protocol documents data recording of system parameters, control system tests, sequence of operation tests, operational safety alarm tests, and 21CFR Part 11 assessment. The Process and Water OQ protocols include, but are not limited to, the following verifications:

  • System OQ Protocol
  • Test Instruments’ Calibration Verification
  • OIT Screen and Security Level Verification
  • 21 CFR Part 11 Assessment
  • Control System Alarm Verification
  • Equipment Mode Verification
  • System Performance Verification