We see the planning and realisation of processes and systems for pharmaceutical solids production as a benefit for our customers. Not only in the field of machine technology, but also in project management, technical Documentation and qualification, it is our aim to present our customers with the best results.
L.B. Bohle has implemented a validation master plan to define and implement qualification measures and the resulting further processes. All documents are based on the V-model life cycle. A distinction is made between the Bohle Validation Plan (BVP), a generic document - which is used for all projects and processes - and the project-specific document Bohle Validation Project Plan (BVPP).
Qualification at the customer's premises is always carried out by an L.B. Bohle service technician or commissioning engineer. In the case of plug-in systems or systems that are no longer significantly dismantled for transport, qualification can also be carried out directly by L.B. Bohle.
L.B. Bohle prepares the machine and system Documentation in accordance with the Machinery Directive 2006/42/EC.
Thanks to the close cooperation with project management, project or customer-specific requirements are directly implemented when creating the documentation.
The use of an editing system ensures the consistently high quality of the documents. L.B. Bohle also has translation software. Together with external translation agencies, a large number of languages can be realised.
Your contact for Documentation & Validation
Contact us and let us advise you without obligation. We will be happy to provide you with reliable support.
Peter Gammersbach
Technical Documentation / Validation Officer
E-mail: inquiry@lbbohle.de
Telephone: +49 2524 93 23 0
