FDA 21 CFR Part 11 & GAMP guidelines

Design and innovate the process, simple configuration brings it into compliance.

  • Electronic records & signatures, audit-trail, alarms, archives
  • 100% Redundant operation, Data integrity & security
  • Integral functionality
  • GAMP S/W category 4, configurable software
  • Tight integration of SCADA logic, one database
  • Standalone to fully integrated systems
  • Production & Batch reporting
  • Out of the box GMP


Pharma Validation Process Costs

IU Magazine Article

Pharma Validation Process Costs

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