Regulated companies live and die at the hand of being first to bring the “best in class” product to the market rapidly without jeopardizing regulatory compliance. They must ultimately achieve a mature product development process coupled with a low compliance burden. Quality Document Manager helps companies make training and control document management part of the culture that permeates the organization—enabling consistent development and production of high-quality Medical Device products that will meet or exceed regulatory requirements.
Quality Document Manager automates and effectively manages enterprise wide control document and training processes. It can greatly simplify the document change and revision process and more importantly, reduce risk associated with the use of erroneous and outdated procedures.
Quality Document Manager manages control document revisions, approvals, training, and periodic reviews. Proposed changes are evaluated, justifications are documented and change plans are mapped out. Tasks are defined for reviews and approvals. Training can be assigned and tracked. Approved changes are released and implemented across operations. Quality Document Manager allows cross-functional teams to collaborate, capture, and approve the control document changes and implementations. Lifecycle tools can be used to ensure a consistent implementation of the approved effectivity and periodic reviews can ensure on going compliance.
Quality Document Manager helps to ensure and record that all effected staff are aware and trained to utilize new or revised control documents. For each new or revised item released, the system automatically sends notifications to personnel who are affected by that control document. The automatic training process engages staff for acknowledgement when documents are approved, and requires electronic signatures to verify they have performed any related mandatory training tasks.
Quality Document Manager automates good workflow management practices and promotes accelerated time to market. Medical Device companies can launch their products to market faster by enabling the entire development team to execute and communicate their tasks more efficiently.
Lower costs and streamline operations from change orders through release approval, dissemination, and training.
- Easily search documents and training requirements
- Secure access to current and accurate documents at all times
- Organize/sort using template and filtering tools
- Coordinate and control training implemented across multiple business groups, entities or locations
Reduce errors and cycle times with automated revision management
- A consistent, compliant closed-loop method to process any type of change
- Automated review process and approval routings
- Notification of new or changed documents based on affected roles
- Eliminate wrong document use with built-in automated training
- Notification/Acknowledgment process
- Meet regulatory/legal/safety requirements with a fully compliant automated training process and document management
- Easily prove training compliance with an auditable training program