Why choose PLG’s Digital Quality services

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

  • Developing Digital Quality Strategies to drive performance improvements
  • Offering a range of scalable services that ensure your digital assets are maintained in a compliant status.
  • Enhancing our client’s capability by focussing on our client’s specific needs.
  • Working across all GxP domains (GLP, GCP, GMP, GPvP, Medical Devices).
why choose plg
digi_val2

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