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.