Regulatory Compliance & Document Control
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Pharmaceutical Compliance Guide
Key Regulatory Challenges
Complex FDA 21 CFR Part 11 Compliance
Impact: High documentation burden and audit preparation costs.
Siloed Data Across Systems
Impact: Documents scattered across departments causing lack of real-time visibility.
Manual Regulatory Submissions
Impact: Time-consuming, repetitive preparation with inconsistent formatting.
Uncontrolled Document Versions
Impact: Risk of using outdated SOPs leading to compliance gaps and audit findings.
Document Control & Approval Workflows
Automated Document Lifecycle Management
Centralized control for SOPs, STPs, Protocols, Specifications, COAs, QMS records, and Manuals—all retrievable by role/department and fully traceable. Documents such as SOPs, STPs, Protocols, Specifications, COAs, QMS records, Manuals are all centrally stored, retrievable by role/department, and fully traceable.
WORKFLOW:
- Central repository for all controlled documents
- Metadata tagging (document type, product, revision)
- Full-text and structured search capabilities
- Version history and audit logs for every action
- Role-based routing (QA reviewers, Approvers)
- Configurable workflow states (Draft → Review → Approve → Publish)
- Automatic email notifications and escalations
- Electronic signatures tied to approvals
Pharma Value
Full digital trail of who did what and when—critical for FDA and EMA inspections. Reduced cycle time compared to paper/manual flows.
SOP Management
Complete SOP lifecycle management from creation to retirement. Regulated organizations maintain SOPs that are always current, easily auditable, and role-specific.
- Creation, revision, and controlled publishing
- Revision control with version comparison
- Retire/supersede outdated procedures
- Assignment to functional groups
STP & Protocol Management
Standard Test Procedures and protocol management for traceable product quality records and customer trust.
- Secure storage with traceable history
- Automated access restrictions by role
- Link COA to product batches
- One-place retrieval of product release documentation
- Quick audit trails for inspections
Change Control
Any change to controlled docs or processes is documented, approved, and traceable. Supports CAPA/regulatory change management expectations.
- Change requests with structured forms
- Impact assessment tracking
- Multi-level approval routing
- Documentation of reason and authorization
- CAPA integration for corrective actions
License Document Management
Track licenses, permits, and certifications with expiry alerts. Prevents legal lapses due to expired licenses.
- Expiry alerts and notifications as per Reminder Policy
- Document classification by type
- Renewals workflow automation
- License expiry calendars
- Compliance tracking dashboard
Policies & Manuals
Regulatory bodies expect documented policy awareness across departments. Corporate policies, quality manuals, and compliance documentation.
- Version control for all corporate policies
- Controlled distribution to departments
- Read/acknowledge tracking (who has read)
- Policy awareness documentation
- Audit-ready policy repository
Regulatory Document Generation
AI-Assisted Submission Preparation
Preparing regulatory submissions (dossiers) is manual, repetitive, and time-consuming. Inconsistent formatting and terminology across documents creates additional review cycles and delays.
Our AI-assisted document generation accelerates regulatory submissions while ensuring consistency. Legacy paper documents can be converted through our digitization services, and archived submissions are securely stored in our records management system for quick retrieval during audits.
- AI-assisted generation of regulatory documents
- Automated cross-referencing for consistency
- Support for multi-region submission formats
- Streamlined stability reporting
Submission Impact
AI-assisted generation with automated cross-referencing
Standardized outputs across all submission types
Multi-region format support and validation
Key Benefits for Pharma
Regulatory Compliance Support
Our solutions are built on a "Validated-Ready" architecture, aligned with global regulatory mandates for pharmaceutical manufacturing.
Regulators Expect:
- Controlled electronic signatures
- Secure, immutable audit trails
- Time/date stamps on all actions
- Version comparisons
- Access controls
- Archival and retrieval
Our System Provides:
- Comprehensive audit trail
- Role-based access
- Configurable workflows
- Document lifecycle controls
- Electronic signatures tied to approvals
Ready to Streamline Your Regulatory Compliance?
See how our document control and regulatory compliance solutions can prepare you for any audit.
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