ValGenesis for Laboratories
Laboratories play a crucial role in the development of new drugs and detection of disease for treatment. An estimated over 60 percent of all decisions regarding a patient's diagnosis and treatment, hospital admission and discharge are based on laboratory test results. In order to ensure the accuracy of the results and meet regulatory requirements such as the FDA’s Good Laboratory Practice (GLP). Laboratories must implement and maintain a proper quality management system (QMS).
Good Laboratory Practice (GLP), section 58.63, requires that laboratories conduct Period 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 are seeking solutions that enable them to sustain compliance and standardize the quality process. Every instrument and equipment need 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 is modularized, with modules for Planning, Risk Assessment (FMEA), Requirements Management, dynamic Traceability Matrix creation, Document Authoring, paperless Electronic Execution, Periodic Review scheduling and Content Management. ValGenesis helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents.
Pharmaceuticals and Biotechnology industries etc. can efficiently handle their unique asset management processes with real time validation status using ValGenesis Asset Management function.
Computer System Validation
ValGenesis is designed to manage the complete validation lifecycle for computerized systems. Life Science companies can replace tedious paper based manual system with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the CSV process 100% electronic.
Equipment Validation and qualification is a time consuming process that has the potential to delay the release of products to the market. Life Science companies can replace tedious paper or manual system with an electronic validation lifecycle management system that makes the equipment validation process 100% electronic.
Method validation is the process of establishing documented evidence that a method is suitable for its intended use. Life Science companies can replace inefficient paper manual system with an electronic validation lifecycle management system that makes the equipment validation process 100% electronic.
The current cleaning validation approach, which relies on paper and manual systems, is time consuming and inefficient as documents are needlessly recreated and tedious manual tasks are performed on a routine basis. Life Science companies can replace tedious paper or manual base cleaning validation process with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the cleaning validation process 100% electronic.
Automated Periodic Review Process
Periodic review schedules are created and routed for approval through ValGenesis. Approved periodic review and revalidation schedules are automatically written to a central validation calendar. The validation schedule calendar can be viewed by the week, month or year. Selected Groups (groups selected at the time of schedule creation) will be alerted of upcoming or delayed periodic review and revalidation tasks automatically through corporate email system.
Change Management Process
ValGenesis system provides a closed loop change management process; the process begins with the initiation of the Change request, which may from an internal member of the company. In ValGenesis, change control and validation are intertwined in order to achieve a completely closed loop quality management process. The change control process with ValGenesis follows GAMP 5.0 guidelines while providing users with the flexibility to configure the change management process to meet their existing business processes.