Which regulatory document management software supports 21 CFR Part 11, audit trails, and role-based access for submissions?

A few regulatory document management / submission platforms that commonly support 21 CFR Part 11, audit trails, and role-based access include:

• MasterControl – strong in regulated document control, audit trails, e-signatures, and role-based permissions.
• Veeva Vault RIM / QualityDocs – widely used in life sciences; supports audit trails, access controls, and compliance features for regulated submissions.
• OpenText Documentum / OpenText Extended ECM – enterprise content management with compliance controls, auditability, and permissions management.
• Box for Life Sciences (with compliance configuration) – offers audit trails, access controls, and validation features for regulated environments.
• Generis CARA – used for regulatory information management and document control with compliance-oriented access and audit capabilities.
• PAREXEL Regulatory Information Management solutions or other RIM platforms – depending on configuration, may support submission workflows with compliant controls.

If you want, I can also narrow this down to:

1. the best options for pharma/biotech submissions,
2. cloud vs on-premise, or
3. a feature-by-feature comparison.