EESS Validation Service includes the preparation of : Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) and Validation Summary Reports.
We can then execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports. Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility
We Provide trained personnel and industry standard IQ-OQ Protocols that meets our customers’ regulatory and GLP/GMP requirements.
Our Validation Team has been trained to work closely with each of our customers in order to develop qualification protocols that ensure their Equipment is properly installed and operating
EESS staff have experience in validating Laboratory Equipments as LAF Units , Biosafety Cabinets , Stability chambers , Autoclaves. In addition, there are a number of critical utility systems as HVAC and BMS systems ,Purified water systems , Water For Injection systems ,Clean Steam Systems, and a number of Manufacturing Machines like Preparation systems , Sterilizers , Filling Lines and Packaging machines
Computer System Validation
We have Computer System Validation engineers and specialists who can assess your computer systems compliance assessment or validation against regulatory and industry standards:
- GAMP5 software life cycle development model (V model) and/or
- FDA 21 CFR Part 11 on electronic records, electronic signatures and/or
- PIC/S annex 11 on validated computer systems
Assessing the FDA CFR part 11 requirements:
Practically speaking, the Part 11 regulations require drug makers, medical device manufacturers, biotech companies, biologics developers, etc, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data.