Compliance

Technical, Strategic & Compliant Solutions

We provide the following Business & Manufacturing Systems’ Support Services:

    Design

  • Generation of lifecycle documentation from scratch.
  • Assistance in developing new systems and processes, integrating existing systems and processes.
  • Creation of company policies, procedures and operating instructions satisfying all relevant standards and requirements. Achieving Quality by Design (QbD)
  • Control

  • Controlled system decommissioning and retirement.
  • Including proceduralised processes for keeping on track.
  • Right first time, total control.
  • Trigger a training exercise for the staff.
  • Gap Analyses of existing systems and alignment to regulatory, corporate, good practice or quality standards.
  • If a law changes, the policy changes and this will cascade through the dependant processes.
  • Enhance

  • Data Migration.
  • Integrated Quality Assurance for maintaining quality and consistency.
  • Creation of test packages addressing the detailed design components and alignment to required or most appropriate methodologies.
  • Full backward and forward traceability between all elements of design through testing in order to ensure everything is tested, traceable and retrievable.
  • Share

  • Generation of Staff Training programmes and employee curriculum dependant on job role.
  • Culture of keeping up-to-date.
  • Classroom or read and understand depending on severity of the change.
  • Transparency and awareness will lead to compliance and control. Cultural management.

In order to achieve and maintain our systems and processes, a robust and efficiently managed, lean quality system is required. Check out our Quality Systems page for more information.

 

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