Commissioning, Qualification & Validation

The Approach.

ValSource’s approach to commissioning, qualification, and validation is an integrated, lifecycle approach, using our collective experience to prepare an authentic risk and science based approach to the design, validation, operation and maintenance of manufacturing processes.

Commissioning, Qualification and Validation, when planned and performed correctly in an integrated manner, ensures operational efficiency, effectiveness and compliance.

ValSource brings the best minds in engineering, process development and applied statistics, operation, and validation. These women and men are the thought leaders from industry and health authorities. They have developed and successfully implemented proven approaches to process lifecycle validation for Facility, Equipment, System, Laboratory, Cleaning, Computer System, Sterilization, and Processes.

The Pains.

Processes, equipment and systems that just don’t work.

Missed budget and schedule.

Excessive operating costs.

Regulatory penalties.

Failure to achieve speed to market.

Your valuable time, energy and money wasted.

The Relief.

Begin with the end in mind.

Deliver the approach, tools and people to meet budget and schedule.

Transferring knowledge so you conduct only that which is necessary. Execute studies effectively. Operate processes efficiently. Eliminate quality issues.

Deliver people who understand global health authority expectations today and the trends that will affect you. Delivering the lifecycle approach to gain and maintain regulatory approval.

Do it right the first time. This time. Every time.

Time, energy and money invested in a “pain free,” successful outcome.

Services include:

  • Validation master plan development
  • Test function and acceptance criteria development
  • System impact assessment
  • System risk assessment
  • Traceability matrix development
  • Project planning, management, control, and knowledge management tools, including PIMS and Mark Time
  • Protocol preparation and execution
  • Standard operating and maintenance procedure preparation and methods development
  • Periodic assessment, review and requalification planning and execution
  • Resource supplementation
  • Sample gathering, testing, and evaluation
  • Final report development and analysis