GxP Laboratories play a crucial role in the development and testing of new drugs, ensuring accuracy of results while also meeting regulatory requirements such as the FDA’s Good Laboratory Practice (GLP). Laboratories must implement and maintain proper quality management systems (QMS) in addition to validation.
GLP section 58.63, requires 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) states, “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 can both sustain compliance and standardize the quality process. All instruments/equipment must be validated and periodically reviewed to meet compliance requirements.
Manual or paper-based systems require extensive effort to validate and maintain the compliance status throughout the lifecycle of the systems. ValGenesis completely replaces inefficient paper-based validation process with an electronic system. Our unique technology helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs, and policy documents.