isoTracker DMS
Cloud-based document control for ISO and regulatory compliance
About isoTracker DMS
isoTracker DMS is a cloud-based document management module built for quality and compliance teams that need to meet ISO 9001, ISO 13485, FDA 21 CFR Part 11, or GMP requirements. It acts as a secure central repository where controlled documents live with full version history, audit trails, and fine-grained permissions based on group, department, or location. Workflows automate the draft, review, approval, and release cycle with sequential or parallel approval paths, electronic signatures, and automatic reminders so reviews never slip. The module can run standalone or plug into isoTracker's wider QMS suite (CAPA, Non-Conformance, Training, Risk Management) for a single source of truth across the quality system. With a 60-day free trial, SSL encryption, daily backups, and bulk upload plus keyword search, it targets small and mid-sized manufacturers, life sciences firms, and regulated service providers that want enterprise-grade document control without the enterprise price tag.
Pros & Cons
Pros
- Purpose-built for ISO and FDA compliance so audit trails satisfy regulators out of the box
- User-friendly interface with minimal setup time for small and mid-sized teams
- Modular pricing lets teams start with document control and expand into a full QMS
Cons
- Pricing is not public and requires contacting sales for a quote
- Interface feels dated compared to modern SaaS document tools
- Limited native mobile app support and offline functionality
Key Features
Document Repository
Central online repository with bulk upload and keyword search across all controlled documents
Version Control
Automated version control with complete activity history and regulator-ready audit trail
Approval Workflows
Sequential or parallel approval workflows with electronic signatures for internal and external reviewers
Permission Controls
Fine-grained access control by group, department, or location with read-only viewing options
Automated Reminders
Email notifications and review reminders to keep tasks on schedule and documents current
QMS Integration
Native integration with CAPA, Training, Non-Conformance, and Risk Management modules
Secure Archiving
Daily backups and SSL encryption in transit and at rest for long-term retention
Compliance Ready
Built-in support for ISO 9001, ISO 13485, FDA 21 CFR Part 11, and GMP requirements
Pricing
- Full access to document management module
- No credit card required
- Evaluate core workflows and approvals
- 5 to 150 user tiers
- Document management module
- Daily backups and audit trails
- Optional SSL encryption and extra storage add-ons
Best For
ISO Document Control
Managing controlled SOPs, work instructions, and forms for ISO 9001 or ISO 13485 audits
FDA Part 11 Compliance
Enforcing electronic signature and audit trail requirements for FDA 21 CFR Part 11
Multi-Site Policy Distribution
Centralizing policy and procedure distribution across multiple sites or departments
Automated Review Cycles
Automating document review reminders so nothing falls out of revision
Ready to try isoTracker DMS?
Start using isoTracker DMS today and boost your productivity.
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