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Qualification

SERVOLIFT designs the document scope, the qualification documentation as well as the installation and functional qualification using the specific requirements of pharmaceutical companies.


Document scope:

  • Research technical documents
  • Documentation of functional and process flows
  • Creation of system descriptions
  • Creation of documents to implement installation qualification (IQ)
  • Creation of documents to implement functional qualification (OQ)

 Gamp5

IMPLEMENTATION OF A PROJECT ACCORDING TO FDA 21 CFR PART 11, IN THIS EXAMPLE, A BLENDING SYSTEM
Part11

 

 System characteristics:

  • Implementing “Electronic Records/Electronic Signatures” in observance of FDA Guideline 21 CFR Part 11
  • Windows-based security implementation with clear assignment of user recognition and passwords, password lifecycles, password history and defined password lengths
  • Complete audit trail system with encrypted, check sum-secured display of all significant user actions, alarm messages and process data
  • Formula management
  • Creation of batch protocols
  • Presentation of all operating statuses and error messages from the test machines
  • Ability to calibrate the system
  • Regulated remote maintenance capability
  • Creation of qualification documents and implementation of tests for installation qualification (IQ) and functional qualification (OQ)

 

 

 

 

       

Software

  • GE Fanuc iFIX
  • Siemens WIN CC flexible
  • Windows 7
  • SQL Server
  • Microsoft Visual Studio

Hardware

  • TFT-Touchscreen
  • Industrie-PC