Technical Support
Ongoing technical and regulatory consultancy — from GMP gap analysis to DRAP and international requirements.
What technical support means with QCS
Our consultancy covers GMP, DRAP requirements and international expectations across the full lifecycle of a laboratory or manufacturing facility.
Engagements run in seven phases — review and gap analysis, infrastructure, equipment, quality system development, quality system implementation, ISO certification and laboratory accreditation.
Consultants on callWhat is covered
Each engagement is scoped in writing before any engineer arrives on site.
Phase 1 — Review & gap analysis
Comprehensive review report against the applicable standard, with prioritised recommendations.
Phase 2 — Infrastructure
Civil works, lab utilities, room data sheets, furniture, networking, LIMS, HVAC, cleanrooms, safety and CCTV systems.
Phase 3 — Equipment
Lab and production equipment, calibrations, trainings, protocols and DQ/IQ/OQ/PQ qualifications.
Phase 4 — Quality system development
Quality system manual, procedures, work instructions and training material.
Phase 5 — Implementation
Roll-out of SOPs and work instructions with full records, data analysis, internal audit and deviation handling.
Phases 6 & 7 — Certification & accreditation
QMS, EMS, OH&S certification and ISO 17025 laboratory accreditation including proficiency testing.
The paperwork is the product.
An engagement is not finished when the engineer leaves — it is finished when your quality unit has the records in hand.
- Gap analysis report
- Documented quality management system
- Internal audit and CAPA closure
- Audit-ready certification/accreditation dossier
Often scoped together
Equipment Calibration
Certify your instruments against NIST-traceable master standards to establish data integrity across your laboratory and process floor.
Process Validation
Process, cleaning and method validation executed with calibrated master instruments and documented to regulatory expectation.
Equipment Qualification
Full qualification lifecycle for laboratory and production equipment, from design review to performance qualification.