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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)

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

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 Tia Portal
Allen Bradley / Rockwell

Hardware:

TFT-Touchscreen
Industrie-PC