Paperless Validation for GxP Laboratories
With ValGenesis VLMS’ data tracking and automated audit trails, your data is secure, organized, and readily available.
ValGenesis completely replaces inefficient paper-based validation processes with an electronic system that helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs, and policy documents.
GxP Laboratories play a crucial role in the development and testing of new and existing drug substances and drugs, ensuring accuracy of results while meeting regulatory requirements adhering to Good Laboratory Practice (GLP). Laboratories must implement and maintain robust and validated quality management systems (QMS).
GLP section 58.63, requires laboratories to 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 must 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 these requirements.
Manual or paper-based systems require extensive effort to validate and maintain throughout the lifecycle of the systems. ValGenesis completely replaces inefficient paper-based validation processes with an electronic system to provide a robust regulatorily compliant solution. Our unique technology helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs, and policy documents.
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