avaWorkflow offers the basic package for management of Polarion LiveDoc templates and a completely digital review and approval process.
It includes automatic version and history management of templates and records created from them.
For electronic approval, different roles (author, review, approval) can be assigned to individual persons. Ensure the 4-eyes principle when recordings are checked and see at any time what status the recording is in. Users are automatically notified and intuitively guided through the review and approval activities, thus reducing training requirements.
Special checklists are provided to help you validate electronic signatures for Part 11 compliance. These checklists show which requirements are covered by Polarion or our configuration and which activities are still necessary from your company.
- Central administration and use of Polarion Templates (LiveDocs)
- Automatic document history and version management
- Linking of information (work items) in different documents and visualization of their dependencies
- Completely electronic review & approval process: Support of different roles (authors, auditors, approvers) and compliance with the four-eyes principle
- Easy to understand user guidance reduces user training
- Checklists support the proof of FDA Part 11 compliance
avasis solutions offers its own best practice configuration packages based on the technical expertise of the avasis team and the wide range of experience in various projects.