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 COMPUTER VALIDATION

   Vulcanbury Ltd. offers a computer validation portfolio to deliver FDA and MCA compliance through scalable validation and practical industry experience. This expertise can be applied to a diverse range of systems that include:

  • Manufacturing Systems - Distributed Control, PLC's, Smart Instrumentation, Micro controllers.
  • Analytical - Lab Systems - HPLC, LIMs Data Systems, Critical Instrumentation.
  • Business Systems - Databases, Spreadsheets, IT Infrastructure - Servers, COTS & Bespoke Applications
Lifecycle Project Management
  Offering CSV project management techniques to ensure computer systems are correctly validated through the Design, Build and Testing project phases to meet regulatory inspection.

Operational Compliance
  Provide operational systems expertise in areas such as change control management, software upgrades and legacy re validation.

Quality Framework Evaluation
  Evaluating existing quality management frameworks and SOPs to prepare organisations for regulatory inspections and manufacturing CSV auditors.

Strategic Risk Management
  Extensive experience in dealing with business risk management of existing legacy systems requiring re validation.
 

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