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