Our Approach

CVG believes that regulations and guidance documents are only one input into any program – one that must be carefully considered and logically approached during program design. That is why we work with clients to develop requirements documents outlining the critical and key inputs under which their systems are to be designed, and in doing so, provide a clear roadmap for each project, facilitating alignment on approach and objectives. The goal of this approach is to ensure the resulting programs are:

We use a thorough knowledge of global regulations, standards and guidance, coupled with an understanding of the business contexts into which they must fit, to ensure that program design is traceable to the expectations of regulators and auditors but also a good fit for the client. This practice facilitates a critical review and assessment of industry recommendations so that CVG can help clients decide what is relevant to them and when specific alternatives are more appropriate based on applicability to their operations and available justification based on science, risk assessment and/or study data.
A validation program ensures (and documents) adequate control over the manufacturing process, which positively affects business and quality metrics such as scrap, rework, deviation and OOS. As a result, validation programs are designed to leverage, develop and document (share) process knowledge.
Inefficiency is a common complaint for validation programs and a characteristic often ignored in their design. A key element to any program developed by CVG is the integration of a risk-based approach. In addition, CVG maps client processes so that efficiency tools can be applied to ensure maximum compliance and effectiveness while minimizing required resources.
By achieving these objectives, the resulting program becomes sustainable, able to grow with the company, ensuring that the quality system and established level of process control keep pace with business development and expansion.

During program design, we take clients through all regulations (requirements) and guidelines (recommendations) that are relevant to their product portfolios, operational capabilities and market presence (current and future). Where there are defendable alternatives to recommendations, we will ensure adequate justification is clear, documented and part of the program. All programs are created from a comprehensive and detailed design document accounting for relevant regulatory requirements and the business needs of each client. We ensure program design and implementation is compliant to process and product quality needs and ready for audit and inspection.

The following flow diagram shows a high level overview of CVG’s methodology for program development and implementation. Modified versions of this process are used for auditing and/or improving existing programs.

CVG’s Methodology for Program Development and Implementation

Program Specification

  • Agree on specific, relevant guidance sources
  • Translate guidance into a specification
  • Review client operations, resources and documents and perform risk assessment to agree on final specification content (accommodating business needs as well)

Program Design Doc

  • Map current process/operations (including resources, tasks and documents
  • Perform gap assessment against Program Spec
  • Revise map to close gaps and maximizze operational efficiency
  • Translate new map to a Design Document

Program Implementation

  • Develop program documents (complying with Design Document)
  • Review and approve documents
  • Perform training for client personnel

Trace Matrix

  • Traces all requirements in the Program Spec and Design Documents to resulting program documents (i.e., policies, procedures, forms, etc.)
  • Key document for audit preparation and management
  • Key document for future program development