Why choose PLG’s Digital Quality services

To help you increase performance in sync with full compliance, our Digital Quality experts focus on: 

  1. Developing Digital Quality Strategies to drive performance improvements 
  2. Offering a range of scalable services that ensure your digital assets are maintained in a compliant status. 
  3. Enhancing our client’s capability by focussing on our client’s specific needs. 
  4. Working across all GxP domains (GLP, GCP, GMP, GPvP, Medical Devices). 

A holistic approach across 5 key areas

Our services are designed to address problems around 5 key challenge areas for clients: 

  • Consulting

    Removing the common misconceptions and challenges around innovation and regulations. 

  • Ways of Working

    Aligning and developing organisational capabilities, reducing internal friction and frustration. 

  • Delivery

    Simplifying and optimising processes with a quality over compliance approach. Delivery mindset to ensure project velocity. 

  • Operations

    Applying a risk-based mindset and remaining agile. Process alignment, adherence, and knowledge. 

  • Assurance

    Implementing a multi-faceted risk-based assurance program that leads to an improved compliance posture. 

Consulting

  • Delivery mindset – maintain delivery momentum 
  • True risk-based approach 
  • Team players – not police 
  • Metrics based assurance 
  • Lean/agile practices 
  • Right-size validation activities 
  • Adherence to current industry & regulatory expectations 
  • Removing barriers to innovation 
  • Driving value over compliance 

Ways of working

  • Integrated risk-based processes 
  • Built on industry IT best practices (GAMP) 
  • Leverage tools & automation (ITSM, Lifecycle Management, DevOps, Monitoring) 
  • Leveraging supplier efforts  
  • GxP Domain expertise 
  • Real world knowledge vs theoretical perception 
  • Deep understanding of global regulatory requirements & industry engagement 
  • Client processes & systems context 

Delivery

  • Critical thinking / patient-centric 
  • Value added approach 
  • Trusted advisors 
  • Process and technology expertise 
  • True risk-based scalable approach 
  • Global regulatory expertise 
  • Records (eTools) vs documentation 
  • Delivery mindset / right-shoring capability / AI enabled 
  • Capabilities across all GxP domains 

Operation

  • Risk-based mindset to maintain a validated state 
  • Incident/deviation trending, analysis & improvement opportunities 
  • Vendor oversight (release impact analysis) 
  • Scalable change & upgrade/patching management 
  • Effective management of standard/routine Changes 
  • Process effectiveness 
  • Operational compliance (Reduced System CAPAs & Deviations)  

Assurance

  • Deep auditing experience of vendors, projects, processes, systems, infrastructure, and specific technologies 
  • Cross-domain GxP expertise 
  • Improvement planning 
  • Global capability 
  • Efficient and timely Periodic Review