Engineering Compliance: Supporting the building of Compliant Facilities
SeerPharma has a long-standing reputation for helping pharmaceutical, medical device and other life science companies ensure the regulatory compliance of their new or upgraded manufacturing facilities. Our team has worked on a wide variety of facility engineering compliance projects across the APAC region, covering complex operations involved in the manufacturing and testing of:
- APIs and Finished Pharmaceuticals
- Small molecules
- Biopharmaceuticals
- Medical Devices
- Radiopharmaceuticals
- Medicinal Cannabis
- Advanced Therapy Medicinal Products (ATMPs) – Cell & Gene Therapies, mRNA Diagnostics & Therapies
- Hospital Compounding Pharmacy Operations
From facility design reviews to release for manufacturing to workforce training, we deliver end-to-end solutions for every stage of your Facility Engineering Compliance project.
Facility Design Reviews, Construction & Qualification Support
A clear regulatory strategy is critical for determining device classification, the optimal pathway to market, and the milestones to track along the way. Our services include:
- Facility layouts and workflows tailored to your processes
- Essential qualification documentation for audits & approvals
- Qualification of surface finishes, HVAC, environmental conditions, utilities, access control and more
- Cleanroom qualification
- QA oversight of contractors and builders
- Request for Information support to architects and builders
- Commissioning & qualification documentation, including IQ/OQ and PQ
- Requirements Traceability Matrix (RTM) to link testing with requirements
- Warehouse and Facility Temperature Mapping
Process Validation Documentation
Ensure regulatory compliance and product consistency with expert-led process validation documentation.
Computer System Validation (CSV)
Validation for EMS and BMS systems in compliance with 21 CFR Part 11 & PIC/S Guide to GMP Annex 11.
QA Oversight for Sub-Contractors & Vendors
Monitoring and ensuring subcontractor and supplier performance to safeguard regulatory compliance.
GMP for Engineering Training
Equip your team with the knowledge they need:
- GMP for Engineering training for facility project success and ongoing maintenance
Mock Regulatory GMP Audits
Simulated inspections that prepare your business for regulatory scrutiny with actionable compliance improvements. Learn more.
