Validation Services

CCL engages qualified people with over 45 years combined experience in the Validation market area within Medical Device, Pharmaceutical and the Food & Beverage regulatory compliance requirements;

  • Ability to work on projects of R&D, Process, Production Manufacturing and Facility requirements for Products.
  • Offering a flexible approach to your project execution and completion.
  • Taking on full responsibility for your project validation from:
    • Validation Master Plan(s) (VMP)
    • Equipment identification with User Requirement Specifications (URS)
    • Process and Protocol writing for characterisation tests
    • Completion of documentation through to your Validation Summary Report (VSR)
  • Taking on defined responsibility to integrate with existing Project Validation teams, be it:
    • Equipment specification requirements
    • Equipment or Process validation requirements
    • Equipment and Process validation test executions
    • Compiling the Device Master Record (DMR) for products
  • Together create your own company internal Validation School to educate your personnel under a pre-arranged curriculum of validation classes to enable them become more proficient in your required Validation Activities over an agreed period of time.
  • Implementing Risk Management against the requirements of ISO 14971:2007 – Medical Devices – Application of Risk Management to Medical Devices.

As a company we will work within your business Quality Management System requirements alongside the current standards and regulatory requirements. In addition of our own model being based on the principles and practices of validation around the updated ISPE's, GMP and GAMP guidelines for Validation, also the endorsement of the GHTF (Global Harmonised Task Force) Quality Management Systems – Process Validation Guidance.

Validation is establishing documented evidence which provides a high degree of Assurance that a specific process WILL consistently produce a Product meeting its Pre-determined Specification and Quality Attributes.

Ability to work on projects of R&D, Process, Production Manufacturing and Facility requirements for Products.