Comprehensive GxP Document Management
Everything you need to manage documents, ensure compliance, and keep your team aligned—all in one platform. Deploy fast, stay audit-ready.
4-Week Implementation Timeline
We've streamlined the implementation process so you can get GxP-compliant document management up and running quickly.
Week 1: Setup
Create your account, add your team, and customize your document templates. Import existing SOPs or start fresh.
Week 2: Migration
Upload your current SOPs. SwiftDocs automatically sets up version control and approval workflows.
Week 3: Training
Your team learns SwiftDocs in a single day. (Yes, really.) Our guided tutorials make it painless.
Week 4: Go Live
Start creating, approving, and managing documents. You're officially audit-ready.
Why SwiftDocs?
Our implementation is designed specifically for pharma startups and biotech companies that need to move fast.
Fast Implementation
No consultants required. Our self-service setup and guided onboarding get you running in weeks, not months.
100% Compliance Ready ✅
100% 21 CFR Part 11 compliant with 106 automated tests (58 unit + 32 integration + 16 performance). Complete validation package with IQ/OQ/PQ documentation included.
Dedicated Support
Your success team guides you through each phase. Weekly check-ins ensure you hit every milestone.
Core Document Management
The foundation of GxP compliance starts with centralized, version-controlled document management.
Document Repository
Centralized storage for all your SOPs, work instructions, and quality documents. Never lose another file in email. Organize by department, project, or custom categories.
Version Control
Automatic versioning with complete history. See exactly what changed, when, and by whom. Roll back to previous versions with one click. Full audit trail of all modifications.
Document Templates
Pre-built templates for SOPs, work instructions, and protocols. Customize templates for your organization. Ensure consistency across all documents.
Compliance & Security
Built from the ground up to meet FDA requirements and ensure your organization stays audit-ready.
Electronic Signatures
FDA-compliant e-signatures built in. No more chasing down wet signatures. Supports role-based approvals. Full audit trail for every signature. Secure signature capture with biometrics on mobile.
Audit Trail
Every action logged automatically. Show auditors exactly who did what, when, and why. 21 CFR Part 11 compliant logging. Exportable reports for regulatory inspections.
Access Control
Role-based permissions at every level. Quality can approve, authors can draft, everyone sees only what they need. Department-level access control. Time-based access restrictions.
Compliance Monitoring
Continuous validation of document status. Automated alerts for expired documents. Track compliance metrics in real-time. Dashboard visibility into compliance status.
Compliance Reports
One-click reports for active documents, training status, and audit trails. Inspection-ready reports generated on demand. Scheduled report delivery to stakeholders.
Data Encryption
All data encrypted in transit and at rest. Enterprise-grade security infrastructure. Regular security audits and penetration testing.
Workflow & Approvals
Streamline your review and approval processes with customizable workflows.
Approval Workflows
Automated routing for review and approval. No more status update emails. Multi-step approval chains. Parallel and sequential approvals supported.
Review Workflows
Assign documents for review to specific team members or departments. Track review progress in real-time. Automated reminders for pending reviews. Comments and feedback on documents.
Periodic Reviews
Automatically schedule periodic document reviews. Track which documents need review. Compliance reminder system. Historical review tracking.
Quality Management
Track quality events, manage corrective actions, and investigate deviations—all integrated with your document workflows.
CAPA Management
Track Corrective and Preventive Actions from creation to closure. Auto-generated CAPA numbers. Root cause analysis. Action item tracking with due dates. Effectiveness verification. Trends and analytics dashboards.
Deviation Management
Document and investigate deviations from procedures. Severity classification. Investigation workflows with findings documentation. Link deviations to CAPAs. Full audit trail of all investigation steps.
Quality Events
Integrated quality event tracking across your organization. Priority-based assignment. Status tracking from open to closure. Real-time notifications for quality team. Trending analysis to identify patterns.
Notifications & Communication
Stay informed without staying in the app.
Smart Notifications
Email alerts for approvals, reviews, and periodic reviews. In-app notification center. Push notifications on mobile devices.
Customizable Alerts
Set notification preferences per role. Quiet hours to avoid off-hours notifications. Digest mode for batch notifications. Notification history and search.
Real-Time Updates
Live notifications when colleagues are reviewing documents. Instant workflow updates. Real-time collaboration indicators. Live edit notifications.
Search & Discovery
Find what you need, instantly.
Advanced Search
Full-text search across all documents. Find any document in seconds. Search by content, metadata, or custom fields. Saved search queries.
Smart Filters
Filter by document type, status, author, or date. Multi-select filters. Dynamic faceted search. Filter combinations saved for quick access.
Elasticsearch Powered
Lightning-fast search across millions of documents. Typo-tolerant search with suggestions. Relevance-based ranking. Search synonyms and related terms.
Advanced Features
Enterprise capabilities built for modern teams.
AI-Powered Assistance
Draft SOPs faster with AI suggestions. Get compliance recommendations. Claude AI integration for document analysis. Grammar and clarity checks.
Training Management
Assign and track training completion. Automated reminders for required training. Training records tied to documents. Certification tracking.
Multi-Tenancy
Support multiple organizations or departments. Completely separated data. Shared resources with separate access control. Sub-organization management.
API Access
REST API for custom integrations. Webhooks for event notifications. SDK for common languages. Comprehensive API documentation.
Background Jobs
Automated compliance checks run in background. Document expiry processing. Bulk email campaigns. Index updates happen seamlessly.
Analytics Dashboard
Track document lifecycle metrics. Monitor approval times. Compliance status visualization. Team activity trends and insights.
HR Compliance & Personnel Management
Maintain complete employee credential records for regulatory audits and compliance inspections.
Employee Credential Management
Centralized storage for employee resumes, CVs, and certifications. Track professional qualifications and licensing. Upload and version control all credential documents.
Training & Certification Tracking
Maintain complete training records with dates and approval status. Track required certifications and renewal dates. Automatic reminders for upcoming training deadlines.
Compliance Audit Ready
Generate compliance reports for FDA inspections. Complete audit trails for all personnel records. Demonstrate employee competency documentation during regulatory reviews.
Integrations & Extensibility
Works with your existing tools and infrastructure.
Cloud Storage Integration
AWS S3 for document storage. Automatic backup and recovery. Scalable storage for organizations of any size.
Email Integration
SendGrid for notifications. SMTP support for enterprise email. Email forwarding for document management.
SSO Integration
SAML 2.0 support for enterprise SSO. Integration with Okta, Azure AD, and other providers. Team provisioning automation.
Database & Cache
PostgreSQL for reliable data storage. Redis for high-performance caching. Elasticsearch for powerful search.
Next Steps
Ready to get started? Learn about our transparent pricing and find answers to your questions.
Ready to see these features in action?
Join our waitlist to get early access when we launch. Experience GxP-compliant document management built for modern pharma teams.
- Priority access when we launch
- Exclusive early adopter benefits
- Updates on our launch progress
- First to experience our compliance platform