FormKiQ's Clinical and Regulatory Document Management solution provides a governed document layer for organizations operating under FDA, EMA, ICH, and similar regulatory frameworks — where document control is not an operational preference but a regulatory requirement.
What Clinical and Regulatory Document Management covers
Manage clinical trial documentation, regulatory submissions, quality system records, and supporting compliance documentation with the version control, access management, audit trails, and retention policies that life sciences regulatory frameworks require.
- Controlled document authoring, review, approval, and distribution workflows aligned to quality management system requirements
- Version control and change management that ensures document histories are complete, traceable, and accessible without confusion with current controlled documents
- Access management enforced at the document level with role-based permissions appropriate to regulatory environments
- Audit trails for every document action — creation, review, approval, distribution, and access
- Retention policies configured to regulatory framework requirements by document type and jurisdiction
- Regional deployment options to support multi-jurisdiction regulatory submission requirements
Recommended platform configuration
Edition
FormKiQ Enterprise
Modules commonly used
Document Generation, Enhanced Full-Text Search, AI Processing and Analysis
Common fits: pharmaceutical and biopharmaceutical clinical and regulatory documentation, medical device quality management system documentation, contract research organization document management, and any life sciences organization with formal document control obligations under applicable regulatory frameworks.