• Manufacturing Systems

 
 
 

Compliance Services

USDM Life Sciences provides qualified resources to plan and execute the computerized system qualification and validation activities necessary to ensure compliance of the system with applicable client policies and procedures in conformance with regulatory expectations and industry best practices (GAMP5).

Typical activities performed by compliance teams include:

  • Provide validation leadership and quality oversight to project team
  • Provide subject matter expertise and leadership/guidance to the assessment, strategic planning and overall execution of systems validation activities
  • Lead risk analysis workshops and provide SME support to development of risk-based validation approach (where applicable)
  • Conducts business user interviews
  • Create project deliverables (strategy, plans, test plans and scripts and summary reports)
  • Leads creation, review and refinement of deliverables
  • Works closely with system owners and client IT QA to ensure conformance with client SDLC and applicable regulatory requirements
  • Support, oversee or execute testing protocols (e.g., FAT/SAT | IQ/OQ/PQ | User Acceptance Testing)

The validation of the proposed solution will follow the methodology defined in the client SDLC. USDM typically employs a value-based approach to validation, which maximizes the time available for system development and implementation without compromising regulatory compliance.

The key elements of this approach include:

Manuf Compliance

Working closely with the integration team USDM will establish an implementation and validation approach that restricts or eliminates duplication of effort, especially during testing wherever possible.

USDM will ensure that deliverables meet client validation and quality standards.

USDM validation staff will work with the integration team to develop an overall project plan where validation deliverables are developed in parallel with development deliverables, wherever possible.

Typical Compliance Staffing

Validation/Qualification Lead – responsible for managing the compliance project, as well as developing and leading the development of validation deliverables. Serves as the primary day-to-day validation resource and contact for client. Responsible for managing review and approval of validation documentation, obtaining document approval and signatures, and compiling the validation package of final deliverables and supporting documentation.

Senior Validation Consultant(s) – responsible for developing the IQ/OQ Plans, Test Scripts and IQ/OQ Summary Reports for the test environment and production environment. Works closely with integration team to develop and execute IQ checklists for all components of the solution including interfaces and any custom code. Develops all User Acceptance Testing (UAT) deliverables (e.g., protocol, test scripts/test scenarios, summary report), collates test data, supervises test execution, and manages test deviations and incidents/issues.

Compliance and Validation SME – responsible for the quality of all validation deliverables. Provides industry insights, compliance SME and computer system validation advice and guidance to the project team. Facilitates risk analysis and validation planning

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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