GxP-Validation-and-Maintenance-services

Ensuring compliance and optimizing operations.

PLG’s Engineering Centre of Excellence goes even further to provide both a full suite of site and data compliance activities, and optimization consulting for waste, energy, and maintenance.

Validation and Qualification activities
  • Technical definition and execution of qualification/ validation protocols DQ, IQ, OQ and PQ
  • Validation Master Plan
  • Commissioning activities, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • HVAC and Utilities (PW, WFI, PS), Process Equipment Qualification & Thermal Mapping
  • Execution of calibration programs
  • Quality Risk Management, GMP Reviews, Risk Analysis and definition of adaptation plans
  • Drafting of supporting standard operating procedures (SOPs), work instructions and guidelines

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Data & Compliance activities
  • Computerised Systems Validation in all GxP areas (Management Systems, Production Control Systems and Laboratory Applications)
  • Compliance Assessment & Remediation Plans
  • Data Integrity Awareness and Solutions
  • Assessment & Qualification of IT Infrastructures
  • IT Quality System Development:


    - SOP writing

    - Quality Agreement definition

    - Audit Trail Review strategy

    - Customize Validation Strategy

    - IT Audit

    - Training


Waste and wastewater optimization and management
  • Revision of waste classification (EWC CODES)
  • Evaluation of management methods
  • Separate collection organization
  • Disposal optimization
  • Wastewater disposal studies


Energy and telecommunications contract management
  • Cost positioning analysis
  • Research of the best market options
  • Assistance with tenders and contracts
  • Monitoring of consumption and costs
  • Simulation of cogeneration effects on costs


Energy use optimization
  • Energy audits
  • Study of customized solutions
  • Study of cogeneration plants
  • Implementation of eco-friendly systems


Maintenance management
  • Definition of maintenance programs
  • External management of programs
  • Optimization of maintenance activities
  • Contract definition assistance
  • Support in drafting and revising Work Instructions