Life Sciences

The unique processes and cGMP requirements for pharmaceutical manufacturing require a very thorough methodology for control system design and implementation.  We design and implement control, S88 batching, electronic batch records, WIP tracking, reporting, and information system that meet the requirements of 21 CFR Part 11. Our process experience includes control of chemical batching systems, fermentation, CIP/SIP, medical device manufacturing, autoclaves, centrifuge, and WFI systems.

 

Our Core Competences

  • GAMP Life cycle knowledge and experience
  • FDA 21 CFR Part 11 compliance for control systems
  • Control System Validation
  • IQ, OQ, CSV development and implementation

Capabilities

  • Process Control
  • Batch Management
  • Electronic Batch Reporting
  • MES

Major Applications Include 

  • Medical device
  • Narcotics
  • Radiopharmaceuticals
  • Bio reactors
  • WFI
  • Vaccines
  • Vascular therapies
  • Medical supplies

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