A contract manufacturing organization can be a contract clinical or commercial manufacturing organization. When a company transfers clinical and commercial manufacturing to a contract manufacturing organization (CMO), the CMO becomes subject to the same regulatory requirements as its client. Contract organizations work with different companies and therefore need to adhere to different regulations. CMOs are frequently audited by their clients and regulatory agencies. Having a robust quality system for CMO’s is not an option but an essential requirement.
Contract Organizations must address the many challenges related to quality and compliance requirements. Currently, most CMO’s have multiple facilities and employees in different locations, maintaining separate quality systems, especially paper-based or hybrid systems. These systems are inefficient, requiring a tremendous amount of effort to manage and complete validation activities.
It is a difficult task to standardize and harmonize validation and quality processes across sites if the process is manual and paper-based. Validation and quality processes that are not integrated with each other are inefficient and cause delays, compliance and business risk. The lack of integration creates islands of information that do not provide a holistic view of the validated state of systems. Integrated quality systems together with validation processes help to expedite the critical compliance tasks and provide a complete history and traceability of the validated state of a particular system. The ValGenesis system completely replaces the inefficient paper-based validation process with a 100% paperless, electronic system. As a core resource for compliance-based validation in regulated companies, ValGenesis is at the forefront of innovative software platforms. This can have a far reaching effect in providing end-to-end validation management, helping companies save up to 40-50% in time and cost across the validation process. ValGenesis’ unique technology manages the entire validation process end to end, dynamically tracking validation status in real time, streamlining the process, improving communication between all stakeholders and ensuring/enforcing compliance and consistency throughout the whole corporate validation process.