The best company to deliver qualification and validation.

By Good Manufacturing Practice (GMP) law, equipment and systems that have a direct impact on the pharmaceutical drug quality, or on medical devices, must be validated. This is to prove that the expected performance can always be reproduced. DOC's Equipment & System Division can organise and execute the qualification and validation of new or in use existing systems; this consists of several activites are fully traced and documented applying the validation lifecycle from the user requirements to the validation maintenance.

Full validation service 

DOC offers an extensive range of services related to validation, through our team specialising in functional areas of the pharmaceutical industry. As well as improving compliance performance and process effectiveness, DOC offers a wide variety of courses, available on registration.

DOC Equipment & System Division Team 

DOC's Equipment & System Division Team is a group of Mechanical and Chemical Engineers who support our clients, providing them with the necessary documents. They also offer support by conducting 'on-site' work that covers the entire qualification process for pharmaceutical equipment and systems like:

• Critical utilities: 
  • Water For Injection 
  • Purified Water 
  • Pure Steam 
  • Process Gases (compressed air, nitrogen) 

• Pharmaceutical Manufacturing Process Equipment for: 
  • API (chemical or biological) 
  • Solid Finished Forms 
  • Liquid Finished Forms 

• HVAC System and related controlled classified areas including: 
  • Unidirectional Air Flow (LAFs) 
  • Environmental monitoring systems (EMS) for critical parameters 
  • Thinking outside the box and tackling problems from different angles

Services 

Our Automated System Sub-Division is made up of computer technicians who provide the validation of computerised control systems, in compliance with Gamp 5 and 21 CFR part 11 requirements. With reference to the validation lifecycle, the Equipment & System Division provides activities and services in the following areas:

• System qualification 
• Validation Maintenance 
• Computerised System Validation