Operational Readiness
Pharmaceutical and medtech manufacturers need strong operational readiness to achieve reliable, compliant and efficient start-up. Many facilities experience delays because cGMP requirements are not fully built into their Quality Management System or because procedures, training and documentation are not ready for daily use. Our Operational Readiness service prepares your people, processes and systems for sustainable commercial operation.
We help you build a compliance-focused QMS, strengthen your documentation and increase site knowledge so your facility is ready for any audit or regulatory inspection.
Building a Strong and Compliant Quality Management System
A successful start-up depends on a QMS that is clear, consistent and aligned with cGMP expectations.
We support clients with the structure and content needed to create a practical and audit-ready system.
Support includes:
• QMS architecture aligned with EU GMP, FDA CFR and ISO expectations
• Audit-ready SOPs, templates, risk assessments and controlled documents
• Documentation that is easy to use, maintain and defend during inspection
• Integration of contamination control and Annex 1 principles into key procedures
Our oversight ensures your QMS supports long-term compliance, not just project completion.
Support for All Leading Digital QMS Platforms
Clients often need their QMS deployed within digital systems. We work with all major platforms.
Platforms include:
• MasterControl
• Qualio
• Dot Compliance
• Veeva and other E-QMS providers
We help you populate these systems with clean, compliant and consistent documents so your QMS is ready for daily operations and regulatory review.
Preparing Your Team With CPD Certified Training
People are at the heart of operational readiness. Our CPD Certified GMP training increases site knowledge and prepares teams for routine manufacturing.
Training covers:
• cGMP requirements and quality fundamentals
• Contamination control awareness
• Role-based training for QA, QC, Engineering and Operations
• SOP execution, documentation discipline and inspection behaviour
• Start-up readiness and issue management
This builds confidence and capability across all departments.
Creating a Smooth Transition to Routine Operation
Operational readiness focuses on practical control of processes, documentation and behaviours.
We work with your teams to ensure:
• SOPs and batch records are complete and ready for use
• Operators are trained and competent
• Engineering controls, maintenance and calibration systems are established
• Deviation management and CAPA processes are functioning
• Performance monitoring is in place for early stability
This prepares your facility for consistent, compliant operation from day one.
Value for Your Operation
• Faster and smoother start-up with fewer issues
• A QMS that is compliant, user-friendly and inspection-ready
• Stronger documentation and operational control
• Improved team capability through CPD Certified training
• Better audit outcomes and fewer repeat findings
• A predictable path to steady-state manufacturing
Clients gain a fully prepared operation supported by a QMS, team and system foundation that meets cGMP expectations and supports long-term success.
