Overview

Efficient asset management is a mandatory requirement within highly regulated Life Sciences industries such as Pharmaceuticals, Biotechnology, Medical devices and Diagnostic industries etc. Regulated companies must meet specific regulatory compliance standards imposed by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), International Standards Organization (ISO), and others. Without effective enterprise asset management, companies within these highly regulated industries may suffer from compliance failures.

The ValGenesis software system can help your company manage GxP assets such as instruments, equipment, systems etc. while maintaining a solid document audit trail and real-time validation status, which improves compliance and ensures consistency in the corporate quality process.  Asset Management functionality is tightly interfaced with the Validation Lifecycle Management modules available in ValGenesis. ValGenesis’s unique asset management enables users to manage the lifecycle of GxP systems from creation, validation, revalidation to retirement.

ValGenesis asset management functionality also provides regulated organizations with the security, configurability and stability they need to track, manage and prolong the life of assets, and meet the complex regulatory requirements enforced by these regulatory agencies.

Features

Pharmaceuticals, Biotechnology, Medical Devices and Diagnostic industries etc. can efficiently handle their unique asset management processes with real time validation status using this functionality. The ValGenesis software solution for Life Sciences features a comprehensive, validated solution for asset management with the following capabilities:

Real-time Validation Status
ValGenesis provides the real time validation status for any GxP assets, through inventory reports available from the dashboard.

Calibration Data
ValGenesis provides and consumes web services, this function displays the calibration data from other systems including SAP QM/PM module, Blue Mountain CalMan, ProCal etc. This will help users to get a validation status of assets, along with calibration data. This provides visibility to ensure proper calibration, testing and verification of GxP systems and processes, to meet regulatory standards.

Periodic Review Schedules
ValGenesis creates periodic review schedules and user groups are automatically notified of upcoming periodic reviews through corporate email.  This  ensures that critical systems and processes are reviewed and validated in a timely manner; therefore reducing the risk of non-compliance.  When a schedule is created in the system, the frequency of periodic review, the type of periodic review, and the groups to be notified of upcoming and delayed periodic review tasks can be configured to meet existing procedures.  Based on the configured periods to alert prior to the due date for a periodic review, the system will send out alert notifications through email.  The system will then continue to send out alert notifications until the periodic review is completed.  If, for any reason, the periodic review was not completed on time, the system will send out additional alert notification to manager groups indicating that the periodic review is incomplete.

Document Control
For any document that is authored in ValGenesis, the system maintains a comprehensive audit trail that will display the activity, the name of the user that completed the activity, the date and time stamp it was completed, and any comments that may have been made.  The audit trail provides a simplified mechanism to view not only where a document has come from but also where it is going to next.  Through document audit trails it is easy to locate bottlenecks and the process and accelerate the overall document development life cycle. Approved documents are securely stored in ValGenesis with access and appropriate distribution rights management.

Audit Trails
Ensure FDA accountability, with accurate audit trail and real time validation status, at the system and document levels.

Electronic Signatures
Enforce criteria-based signatures for operational needs for creation, edit, review and approval of any data and documents with associated time stamps and user audit trails.

Revision Control
Ensures the integrity of documents and preserve maintenance procedures, with built-in review and approval processes.

Record & Data Availability
Print and export records in a variety of formats, while ensuring accurate tracking, with documented record revisions and changes, to meet the compliance requirements.

Benefits

GxP systems, equipment, instruments and processes that are critical and may affect product quality, or patient safety, need to be controlled and evidence of such actions should be maintained and provided.   Maintaining the GxP inventory up-to-date with real time status, promptly identifying the specifications, risk assessments and qualification documents associated with each asset, are just some of the problems associated with current methods. ValGenesis provides the following functionality to eliminate the issues associated with the GxP asset management process.

• Up to four levels of hierarchy can be established to manage assets and mimic current taxonomy, for easy navigation.
• ValGenesis maintains a centralized asset inventory of all equipment, instruments, systems and process, users can gain access from any location, through a simple Web interface.
• The integrated approach employed in ValGenesis allows users to connect the inventory list with requirements, risk assessments, traceability matrices and qualification documents details.
• This integrated approach ensures that the asset inventory is maintained up-to-date with real-time information. In addition, this process identifies and monitors the compliance status of GxP systems, processes, equipment and instruments. The associated documents and information can be used to implement the business process automation through controlled workflows.
• The equipment inventory and qualification, impact assessments, specifications, SOPs, etc are interconnected. The inventory information can thus be more reliable and documents easier to retrieve.
• Traceability across all documents reveals the change impact and highlights out-of-date documents, ensuring that the compliant status is maintained.
• Closed loop quality process, with the change control process available in ValGenesis, ensures compliance status is maintained and modifications are implemented through a controlled change control workflow.
• Closed loop change control and validation processes maintain the assets, with history, including the details of the change and the associated audit trail with version levels.