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Regulatory & Compliance Management
Built-In Quality, Compliance, and
Continuous Improvement for Modern
Laboratories
Regulatory compliance is not optional—it's essential for laboratory operations. Our
LIMS is designed from the ground up to meet the most stringent global regulatory
requirements, ensuring your laboratory is always prepared for audits and inspections.
Overview: Compliance by Design, Not Afterthought
Laboratories across pharmaceutical, biotech, clinical, food, environmental, and manufacturing industries face
increasing regulatory scrutiny. Manual compliance processes are error-prone, time-consuming, and risky. Our
Regulatory & Compliance Management module embeds compliance controls directly into laboratory workflows.
Key Challenges Solved
- Manual compliance tracking and documentation
- Audit preparation stress and resource drain
- Data integrity gaps and risks
- Multi-regulation complexity
- Inconsistent compliance across locations
Our Solution Delivers
- Automated compliance enforcement
- Instant audit evidence generation
- Complete data integrity assurance
- Multi-regulatory framework support
- Global compliance standardization
Key Functional Capabilities
Comprehensive compliance features built into every aspect of the system.
1
Electronic Signatures (21 CFR Part 11)
Secure, legally binding digital approvals for all critical actions.
- Multi-factor authentication options
- Signature meaning and reason capture
- Tamper-evident signature logs
- Role-based signature permissions
- Signature delegation controls
Benefit:
Enables paperless operations with full legal validity
2
Comprehensive Audit Trails
Complete, immutable record of all system activities.
- Time-stamped action logging
- User identification for all actions
- Before/after value capture
- Reason for change documentation
- Secure, tamper-proof storage
Benefit: Provides complete traceability for any inspection or investiga
3
Role-Based Access Control (RBAC)
.
Granular permission management for data security
- Fine-grained permission definitions
- Role hierarchy management
- Segregation of duties enforcement
- Access review and certification
- Emergency access procedures
Benefit: Ensures right people have right access to right data
4
Data Integrity (ALCOA+ Principles)
Ensure data is Attributable, Legible, Contemporaneous, Original, and Accurate.
- Automated data attribution
- Version control and history
- Original data preservation
- Data validation at entry
- Complete, consistent, and enduring records
Benefit: Meets global data integrity expectations from regulators
5
Multi-Regulatory Framework Support
Pre-configured compliance templates for major regulations.
- 21 CFR Part 11 compliance tools
- ISO 17025 accreditation support
- GMP/GLP/GCP alignment
- FDA and EMA readiness
- HIPAA data protection
Benefit: Reduces compliance configuration effort and risk
6
Compliance Reporting &
Documentation
Generate audit-ready reports on demand.
- Regulatory inspection packages
- Compliance status dashboards
- Validation documentation
- Periodic review reports
- Export in regulatory formats
Benefit: Streamlines audit preparation and response
Compliance & Standards Supported
Built to meet global regulatory requirements and industry standards.
21 CFR Part 11
ISO 17025
GMP / GLP / GCP
FDA / EMA
HIPAA
ICH Guidelines
ALCOA+ Principles
EU Annex 11
Built-In Compliance Controls
Electronic signatures with authentication
Time-stamped, immutable audit trails
Role-based access control (RBAC)
Data encryption at rest and in transit
Automated validation rules
Secure backup and disaster recovery
Business & Operational Benefits
Measurable impact across all levels of your organization.
For Laboratories
- Reduced compliance burden
- Paperless operations with full validity
- Faster regulatory responses
- Reduced risk of compliance gaps
For Quality & Compliance Teams
- Always inspection-ready
- Complete audit evidence on demand
- Proactive compliance monitoring
- Reduced manual documentation
For Management
- Reduced regulatory risk
- Faster market approvals
- Enhanced stakeholder confidence
- Lower cost of compliance
Why Our Regulatory & Compliance Management Stands Out
Built-in compliance, not bolted-on
Continuous regulatory updates included
Proven global deployment track record
Comprehensive validation documentation
Dedicated compliance support team
Multi-jurisdiction regulatory expertise
