|
Validation Manager
Comply Serve's Validation Manager for the pharmaceutical and life sciences industry, is designed to automate, manage, track and document the entire validation lifecycle. Validation Manager is the ideal solution to improve the efficiency of the entire validation process, enhance the quality and consistency of validation documents, provide a valuable line of defence against internal or regulatory audits, and reduce the overall costs of validating entities.
For more information on this contact our sales office on +44 121 452 5042
Validation issues in the Pharma & Life Sciences Industry today
Validation Manager has a tremendous potential to improve the efficiency of activities associated with demonstrating compliance in the life science industries. This arises from their ability to link statements across multiple documents that are generated at different project stages. These links mean that it can be quickly verified that all specification requirements, risk information and even the details of test plans or scripts have been addressed and verified and to trace their implementation throughout the project. These advantages further leverage when subsequent changes are made to validated processes, equipment and systems. Because Validation Manager is Web-based it provides a cost-effective collaborative environment that facilitates project planning to better leverage good engineering practices in qualification activities.
Key benefits
- Traceability of all Information
- Automates time consuming and error prone tasks
- Ensures project documentation is completely traceable to specifications
- Role based views; The right people get access to the information that they need
- Project, specifications, documentation and progress can be viewed online by all interested parties
- Faster document approval cycles, critical content can be agreed before document generation
- Facilitates the leveraging of process engineering activities to fulfil compliance commitments
- Highlights the status of critical activities; Team members and other stakeholders can continuously view progress
- Readily accepts project documentation that has not been generated in Validation Manager
- Automatically generates worksheets for design, risk analysis, commissioning, qualification and validation activities
- Change control and Maintenance
- By the end of project Validation Manager has built a compliance register of your facility
- Quick change impact analysis no matter what level the change is made
- Not just for new projects
- Existing product / project / system information can be registered
- Data is stored directly from Validation Manager's pre-configured process templates
Breaking with tradition
Comply Serve does not work like conventional software vendors and has moved away from traditional software deployment approaches by delivering Validation Manager to its clients via the web. This approach removes the ongoing maintenance and infrastructural pains associated with software 'ownership' enabling the user to focus purely on the capability the service offers. Additionally, Comply Serve solutions are tailored for specific market requirements with significant emphasis on ease of use and access.
SaaS Deployment
Because Validation Manager is delivered to the supply chain via a Software as a Service (SaaS) delivery model via the Internet, this helps overcome the introduction of more formal processes, necessary for the demonstration of compliance, by providing process driven solutions that guide the casual user through unfamiliar territory. Subscription based pricing reduces the initial and ongoing investment needed to establish enterprise compliance processes which means wider access and faster deployment.
|
