Operations Control

Develop and implement effective operational processes demonstrating control, compliance, quality and efficiency.

Assisting any aspect of Operations Control including:

Manufacturing In-House:

  • Environment / Clean Room Validation / Control

  • Supplier Evaluation & Selection

  • Supply, Service & Quality Agreements

  • Materials / components specification definition & control

  • Plant / Equipment / Process definition, validation & control (See Verification & Validation)

  • Completing risk management & PFMEA

  • Planning manufacture / Assembly

  • Completing assembly / manufacture / formulation Control

  • Validating processes including packaging / labelling, sterilisation

  • Ensuring batch  / Lot identification / Traceability/ Release / Records

Contract Manufacturing (including overseas)

  • As above

  • Selection & Monitoring

  • See NCR / CAPA

  • Preparation of Quality / Technical Agreements

  • Standard Operating Procedures
  • QMS Standards
  • Manufacturing Instructions
  • Supplier Evaluation and Selection
  • Quality Agreements
  • Technical Agreements
  • Fulfilment Agreements
  • Design Transfer
  • New Product Introduction
  • Manufacturing Specifications
  • Process Definition & Control
  • Process Validation
  • PFMEA
  • Environmental Control
  • Clean Room (Zone) Validation
  • Labelling
  • Packaging
  • Sterilisation
  • Release Control
  • Materials Selection
  • Materials Stock Control
  • Traceability
  • Inspection and Testing
  • Non-Conforming Product
  • Batch Records / Release Control

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    Design / Develop D&D planning, user requirements, verification, validation & change. Risk Management Planning, hazard identification, risk control, benefit-risk analysis. Audit & Monitor Obtaining data to verify compliance: Improve product(s), plant(s), processes, people & controls. Services Technical Documentation Tech Doc collation to evidence safety & performance & meet national regulations. Change Control Controls & risk management of changes to device(s), processes, systems & Tech Documentation. Clinical Evaluation Clinical Evaluation planning, data review, reporting & updating. Services Data Analysis Practical, proven, efficient KPI's to identify, collate, analyse, act & improve products, processes & people. Doc & Data Control Efficient, reliable, traceable Doc & Data controls. Launch & Distribute Importer / Distributor QMS, agreements, traceability, controls and diligence. Services Management Systems Developing & maintaining effective, compliant QMS; improving product, resources, processes & organisation. NCR & CAPA Identifying, recording, analyzing, preventing & correcting product, process & system issues. Ops Management Effective compliant, efficient controls, (incl. outsourced processes). Services Performance Improvement Implementing improvement in your device life-cycle & compliance. Regs & Standards Identifying & meeting relevant regulations, common specifications & standards. Reg Strategy & Plan Regulatory strategies / plans for device development & clearance to market; FDA, CE, UKCA, UKNI. Services Reg Submission Preparing & collating data to reduce time for complaint submissions to gain clearance for product launch. Verification & Validation Planning, verifying, validating designs, processes, environ controls, equipment, products, plant & test methods. Vigilance & PMS Documenting & implementing PMS / PMCF plans, vigilance system & incident reporting. Services GPB - Design Control GPB - Risk Mangement GPB - Audit Monitoring GPB - Technical Documentation Change Control Clinical Evaluation Data Analysis Doc & Data Control Launch & Distribution Performance Improvement Regulation Standards Regulatory Standards Management Systems NCR & CAPA Operations Control Regulatory Submissions Verification & Validation Vigilance & Post Market