Pharmaceutical packaging
Aside from the preparation of documentation for our clients, we also prepare safety concepts for them and conduct detailed coordination of the user requirements between the manufacturers and suppliers. We create technical libraries, glossaries and problem registers in order to archive all the knowledge acquired in the process.
Our services include the coordination and preparation of all the qualification
documentation, for example:
- the creation of user requirement specifications (URS)
- preparation of detailed risk assessments (RA)
- preparation and execution of DQ, IQ and OQ inspections
- project support in FAT and SAT the creation of qualification reports (QR)
We understand the operational procedures and we’re happy to pass this knowledge on to you. We support you in your daily business, for example in:
- qualification of technical changes
- project support in production test runs
- the creation of illustrated maintenance documents (plans, protocols, instructions)
- the creation of SOPs, e.g., for unplanned standstills
- conducting training/knowledge transfer
- optimisation of organisational functions in controlling and camera technology