User Report Siegfried Hameln
FASTEC 4 PRO at Siegfried in Hameln.
The full report is available to download.
The FASTEC 4 PRO Software Solution at Siegfried Hameln
Siegfried, a leading global CDMO (custom development and manufacturing organization), produces active pharmaceutical ingredients, intermediates and finished products from a single source.
Its core competence lies in the integration of complementary chemical and pharmaceutical expertise in a single business model.
Our user report focuses on the site in Hameln, where production has been optimized with FASTEC 4 PRO since spring 2011.
- Industry: Pharmaceuticals/Cosmetics
- Procedure: Six-month test phase, followed by a step-by-step rollout to all machines and work centers
- Technical Implementation: WiFi, direct PLC communication for new machines, I/O modules for older machines, sensors
"We receive key figure evaluations at the touch of a button and can compile individual overviews in the system – the functionality and performance of FASTEC 4 PRO impresses us time and time again."
"The biggest benefit for us is the electronic recording of data. Thanks to FASTEC, we have taken a step towards paperless production – both production employees and management appreciate this reduction in workload."
"FASTEC's support is always available and reliably processes all inquiries. Our IT department has also been very positive about the cooperation with FASTEC – FASTEC has rightly positioned itself as a customer partner."
Short and Precise
Goal: Optimization Potential, Efficiency and Quality
Data acquisition at Siegfried Hameln was previously carried out exclusively via manual data entry and reports When a new building for the sterile filling of parenterals was built in Hameln, Siegfried Hameln’s vision was clear: paperless production in the cleanroom area of the new building Manual key figure processing in Excel had to be replaced by electronic data acquisition in order to obtain precise reports on machine reliability and effectiveness Today, data evaluations are immediately available and can be traced back ten years into the past without any gaps or loss of data The aim from the outset was to derive optimization projects from this data
GMP Validation
Another requirement was validation in accordance with GAMP 5. The company wanted to use resource logbooks to record cleaning steps on the machines, for example Furthermore, not only should machine-relevant downtimes be recorded, but the status of the machine should also be available in real-time This recording in the resource logbook is a GMP-critical process step, which is why the system requires GMP validation based on the user requirement specification Siegfried Hameln has carried out a risk analysis based on its own requirements for production optimization software From this, concrete measures and projects were developed, which were then transferred into a validation matrix and defined as inspection points for GMP validation
Individual Reports at Any Time
Today, data evaluations can be traced seamlessly and without data loss This security is crucial for Siegfried Hameln as a producer of pharmaceutical products The resource logbook is used to create a wide range of reports, diagrams and timelines FASTEC 4 PRO is used intensively in the OpEx area in particular to base optimizations on well-founded data Current production status, modifications or disruptions in production as well as current problems and other questions from employees are analyzed in the department meeting based on the data from FASTEC 4 PRO In addition, the significantly highest downtimes are reported and documented daily as a key figure for the management.
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