Qualification
According to the specific requirements of pharmacists the documentation extent is elaborated, the qualification is planned, the qualification documentation is created as well as the installation and function qualification are accomplished by SERVOLIFT.
Documentation extend:
• Search of technical information
• Documentation of function and operational sequences
• Making of asset description
• Provide the documents for the execution of the installation qualification
• Provide the documents for the execution of the function qualification
Realisation of a project by use of FDA 21 CFR Part 11
System tokens:
• Realization under consideration of the FDA guideline 21 CFR Part 11 " Electronic Records/ Elec-tronic Signatures"
• Windows based security implementation with clear assignment of user identification and password, password lifetime, password history and defined password length
• Extensive Audittrail-system with coded, checksum-secured recording of all essential operator ac-tions, notifications of emergency and process data
• Prescription administration
• Creation of batch records
• Representation of all operating conditions and alert signals of the testing maschine
• Calibration possibility of the plant
• Possibility of regiment remote maintenance
• Creation of the qualification documents and execution of the tests for the installation qualification and function
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Software:
Hardware:
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