Use
Approval documentation, SOPs, training material, audit preparation
Format
HD/4K video and high-resolution photography – for print and digital use
GMP compliant
Documentation and recording concept in line with GMP requirements and 21 CFR Part 11
Deliverable
Edited, annotated material – ready to use in your QMS
Documentation that lasts
Production processes are complex. Complete visual documentation creates clarity – for auditors, for new staff and for the further development of your facility. We record your processes on film and in photographs to the standard of professional industrial production.
Fields of application
Approval documentation
Authorities and inspection bodies expect a comprehensible presentation of your production processes. Our visual documentation meets the requirements of the FDA, the EMA and national regulatory authorities.
SOPs and training videos
Standard operating procedures are only as good as the way they are conveyed. We translate written SOPs into structured training videos that explain complex sequences clearly and repeatably.
Audit preparation
With a complete visual overview of your production facility, you can approach audits with more confidence and greater efficiency. Our material shows your actual situation precisely and professionally.
Our approach
We know the requirements of pharmaceutical production environments. All recordings are made in compliance with applicable hygiene regulations and cleanroom rules. The result: meaningful material that can be used for regulatory purposes – without interrupting your running operations.
- Filming under real conditions – nothing staged
- GMP-compliant documentation of the recording process
- Professional post-production and annotation
- Handover in the formats you require
On request the handover takes the form of a Navigator: an interface in which every sequence is found through the equipment structure rather than through a file name.