Validation Lifecycle Management System (RC-VLM)
Objective of the Validation Lifecycle Management System (RC-VLM)
Our Validation Lifecycle Management system is an end to end solution for development, engineering, implementation, commissioning, qualification and validation to ensure compliance with GxP regulations and company procedures.
RC-VLM can be used for:
- implementation and qualification of laboratory equipment (e.g. HPLC, balances, etc.);
- engineering, implementation and qualification/commissioning of production equipment, facilities and utilities (e.g. filling lines, cleanrooms, etc.);
- development, implementation and validation of information systems (e.g. LIMS, ERP, etc.);
- including agile validation development, implementation and validation of software for medical devices; including agile validation development, implementation and qualification/commissioning of IT Infrastructure (e.g. networks, servers, etc.).
Main functionalities of the Validation Lifecycle Management system (RC-VLM)
- Integrated Project Management;
- Generate an appropriate validation/qualification/commissioning approach for a given system, based on configurable workflow;
- Integrated Risk Management;
- Dashboard providing an overview on the validation/qualification/commissioning process and access to the corresponding documents;
- Document and version management;
- Automated workflow for generation, review and approval of documents;
- Content management, incl:
definition and linking of requirements, risk items and test cases;
possibility to manage content of templates and deliverables in MS Word;
- Integrated requirement and test management;
- Library for definition and inheritance of default requirements and test scripts;
- Design Assistance:
- View documents of similar systems;
- Import requirements and test scripts from existing documentation or library;
- Supplier Assessment & Selection;
- Automated Traceability Matrix;
- Test registration (incl. documented evidence) and defect handling;
- Change Control, incl. version management for software;
Benefits of the Validation Lifecycle Management system (RC-VLM)
Our Validation Lifecycle Management system ensures GxP compliant system development, implementation and validation/qualification/commissioning. Documentation is centrally and readily retrievable. An efficient document review and approval is being enabled by an automated workflow. Through the standardization of approach, documentation and content, consistent and adequate system development, implementation and validation/qualification/commissioning are achieved.
Other benefits of our Validation Lifecycle Management solution are continuous traceability through automated linking of activities, deliverables and content. You can also speed up the validation/qualification/commissioning process by the reuse of content and you will stay in control through automated and central Management Reporting.
With our Validation Lifecycle Management system you are able to establish and maintain paperless validation and compliance.
Request a free demonstration of our Validation Lifecycle Management system.