An efficient and compliant asset management process is a mandatory requirement for highly regulated companies. ValGenesis allows regulated companies to manage the entire lifecycle for all of their GxP assets such as facility, instruments, equipment, computer systems and analytical instruments, while maintaining a solid documented audit trail and real-time validation status for every asset. The GxP asset management capabilities are tightly integrated with the Validation Lifecycle Management functions within the system thereby improving compliance and traceability, thus ensuring consistency in the corporate validation and quality processes. ValGenesis’ asset management functionality provides regulated organizations with the security and accountability they need to track, manage and monitor GxP assets throughout their lifecycle while also meeting the complex regulatory requirements enforced by applicable regulatory agencies. ValGenesis’ asset management functionality provides regulated organizations with the security, and accountability they need to track, manage and monitor GxP assets throughout their lifecycle while meeting the complex regulatory requirements enforced by applicable regulatory agencies.
Keeping GxP assets and inventory up-to-date in real time status, promptly identifying the specifications, risk assessments and qualification documents associated with each asset, are just some of the challenges associated with current paper-based lifecycle processes. ValGenesis is a robust electronic system that manages these functions seamlessly while eliminating the issues associated with the GxP asset management process.
- ValGenesis maintains a centralized up to date asset inventory of all equipment, instruments, systems and processes that can be accessed from any location through a web browser.
- ValGenesis’ integrated approach ensures that the asset inventory is maintained and up-to-date with real-time validation status information.
- ValGenesis provides the ability to conduct a risk assessment for any asset or process. This allows users to determine the level of validation or verification effort required (i.e. what documents are considered necessary) in order for the system to be considered validated or verified.
- ValGenesis GxP system electronic logbook Manager Module provides users with the ability to record cleaning, preparation and usage logs for GxP assets. Within the GxP system electronic Logbook Manager, real time cleaning, preparation and usage logs are readily available. This provides users with an integrated validation status of assets, along with cleaning and usage logs.
- The integrated change control management function available in ValGenesis ensures that compliance status is maintained and modifications are implemented through a controlled change control workflow. External Change Management processes can be easily interfaced to achieve an integrated change management process with validation deliverables managed in ValGenesis.
- ValGenesis enables users to pull the calibration data from other systems including the SAP QM/PM module, Blue Mountain CalMan etc. through web services. Calibration data can be viewed for any GxP asset along with cleaning logs, usage logs and validation data.
- Periodic review and revalidation schedule management functions available within ValGenesis allows users to define a planned, structured approach to ensure that GxP systems and processes are periodically reviewed and revalidated on time.
- A controlled decommissioning/retirement process allows users to enforce the approved retirement process with documented evidence.