• Services:
• Staff training
• Customer trials for support in PQ
• Re-qualification in modifying already qualified systems
• Machine maintenance
• System calibration
• Change Control
• Vibrator discharge aids testing of discharge trials

• GMP compliant DQ / IQ / OQ qualification
We provide implementation and document compilation for the qualification of L.B. Bohle systems. Qualification is carried out to a large extent in-house during assembly of the machine. The qualification can be adapted to meet the customer’s requirements.

• DQ (Design Qualification)
Documented proof of regulations, performance data and specifications are taken into consideration during planning.

• IQ (Installation Qualification)
Documented proof that the assembly of the machine is in compliance with the plans, regulations, performance data and specifications .

• OQ (Operations Qualification)
Documented evidence that the functioning of the system meets the production requirements.
(initial calibration, manual mode, automatic, error messages)

• Computer validation according to GAMP 4
The GAMP 4 Directive specifies various development stages of the SPS and/or computer supported control system based on the specifications to qualification according to the V model (Life Cycle Model). Bohle provides this documentation optionally and supports the customer in the validation of the entire system.

• Electronic Batch Record according to 21 CFR Part 11
The employed software can be configured optionally for compliance with the FAD 21 CFR Part 11 Directive. The associated documentation describes the implementation of the individual provisions in the Directive and documents the correct installation of the software in the machine.

• Benefits:
• GMP compliant qualification
• Cost-efficient qualification
• Costs for qualification are already specified when purchasing the   system
• Time-saving during implementation.