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Documentation & Compliance AMC ensures structured documentation, audit readiness, and regulatory compliance for tissue culture laboratories, biotechnology units, and clean room facilities.
Proper documentation is essential for:
GMP compliance
Export approvals
Quality assurance
Traceability
Regulatory inspections
This AMC service supports SOP management, logbook maintenance, internal audits, and validation documentation to keep your lab inspection-ready at all times.
Ideal for:
Commercial Tissue Culture Labs
Agri Biotech Units
Research & Development Labs
Export-Oriented Micropropagation Facilities
🔧 Detailed Service Scope
1️⃣ SOP Review
Systematic review of Standard Operating Procedures:
SOP structure verification
Technical accuracy review
Compliance alignment check
Revision control monitoring
SOP update recommendation
Ensures updated and standardized lab processes.
2️⃣ Equipment Logbook Maintenance
Support for equipment documentation:
Logbook format verification
Usage entry review
Calibration record tracking
Preventive maintenance log check
Signature & authorization validation
Maintains equipment traceability.
3️⃣ Maintenance Record Documentation
Structured documentation support:
Preventive maintenance record formatting
AMC service documentation review
Breakdown maintenance recording
Compliance file organization
Document retention planning
Improves audit transparency.
4️⃣ Internal Audit Support
Preparation and assistance during internal audits:
Documentation checklist preparation
Audit readiness review
Gap analysis
Corrective action plan guidance
Mock audit support
Reduces non-compliance risk.
5️⃣ GMP Compliance Assistance
Guidance aligned with Good Manufacturing Practices:
Documentation format standardization
Hygiene & maintenance documentation check
Validation record support
Training documentation review
Compliance improvement suggestions
Strengthens regulatory readiness.
6️⃣ Validation Documentation Support
Support for validation processes:
Clean room validation record support
Equipment validation file review
Installation Qualification (IQ) documentation guidance
Operational Qualification (OQ) support documentation
Performance Qualification (PQ) record structure
Ensures structured validation documentation.
📦 Deliverables
SOP review report
Documentation gap analysis report
Equipment logbook compliance checklist
Internal audit preparation report
GMP documentation review summary
Validation documentation support file
Annual compliance performance report
🎯 Key Benefits
✔ Audit-ready documentation
✔ Improved traceability
✔ Regulatory compliance readiness
✔ Reduced inspection risk
✔ Structured quality management
