GxP Laboratories plays a crucial role in the development and testing of new drugs so as to ensure the accuracy of the results, while also meeting regulatory requirements such as the FDA’s Good Laboratory Practice (GLP). Laboratories must implement and maintain a proper quality management system (QMS) which includes validation
Good Laboratory Practice (GLP), section 58.63, requires that laboratories conduct periodic review and calibration of equipment used for GLP studies; maintenance and calibration of equipment must be conducted according to a set schedule. Section 58.63(a) “Equipment shall be adequately validated, cleaned, and maintained.” Equipment used for the generation, measurement, or assessment of data shall be adequately validated, calibrated and/or standardized. As a result, an increasing number of clinical, quality control and medical laboratory organizations seek solutions that enable them to sustain compliance and standardize the quality process. Every instrument and equipment must be validated and periodically reviewed to meet the compliance requirements. The current manual or paper-based systems require extensive effort to validate and maintain the compliance status throughout the lifecycle of the systems.
ValGenesis completely replaces the inefficient paper-based validation process with an electronic system. 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 and enforcing compliance and consistency throughout the whole corporate validation process. ValGenesis helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents.