Document Control Module

Grand Avenue's Document Control Module is a web-based solution designed to manage and track documentation workflows for life sciences and MedTech organizations. It supports compliance with FDA and ISO regulatory standards by centralizing document storage, automating change request processes, and maintaining complete audit histories. The module is built to suit growing companies, including startups, and is designed to scale as organizations expand.

The module functions as part of Grand Avenue's broader eQMS platform, integrating with other modules such as Audit Management to support internal quality processes. Documents are submitted, reviewed, approved, and tracked through a single secure system, with role-based access control limiting document access and modification to authorized personnel.

Core Capabilities

• Centralized document vault with version control and full audit history
• Automated change request workflow covering submission, approval routing, and implementation
• Structured impact tracking organized by change type and category
• Role-based access control to protect sensitive documents during revisions
• Integration with Audit Management and other eQMS modules
• Real-time dashboards and automated reminders to monitor progress and deadlines
• Online proposal review and flexible deviation tracking
• Training verification tools with automatic assignment of training on newly revised documents
• Customizable process impacts to track change order tasks that occur outside the system, such as ERP updates or manufacturing workbook changes

Document Change Request (DCR) Workflow

1. Submit a document change request or deviation through the centralized web-based interface
2. Assign roles and set due dates for each step in the review and approval process
3. Route the request automatically for approvals, reducing manual follow-up and delays
4. Track all revisions and approvals with version-controlled document history
5. Assign implementation tasks, including training assignments and customized accountability tasks, within the DCR process
6. Store all completed records securely for regulatory audit readiness

Compliance and Audit Readiness

• Maintains audit trails that log all document changes, approvals, and access events
• Supports compliance with FDA and ISO document management regulations
• Ensures approval from relevant personnel is captured and traceable
• Flags deviations and ensures all changes are logged and version-controlled for regulatory review
• Keeps records secure with role-based access, ensuring only authorized users can modify important documents

Grand Avenue's Document Control Module is deployed as a web-based system, making it accessible without significant infrastructure requirements. It is positioned for fast deployment and is suitable for organizations at early growth stages through to those operating globally, as reflected in case studies from companies including Checkpoint Surgical, MedLaunch, and Innovia Medical.