Pharma Compliance –
A definition
The pharmaceutical industry is a highly regulated sector – in hardly any other area are there so many laws, regulations, quality standards and rules. And rightly so: medicines have an enormous impact on patients’ lives. The manufacture and distribution of such drugs are therefore subject to high regulatory standards. This makes compliance in the pharmaceutical industry – pharma compliance for short – one of the most important priorities for medical pharmaceutical companies. Without compliance according to the latest standards and the highest level of transparency, it is not possible for a pharmaceutical company to commence business operations.
Why Track & Trace?
Maintaining pharmaceutical compliance can be made easier for modern companies through digital transformation. Traceability, i.e. tracking, using audit trail software along the manufacturing process and the entire value chain provides the necessary transparency. By means of track and trace, manufacturing processes and production quality can be ensured and proven.
It was particularly important to Uhlmann that a clear integration and data architecture was created – sustainably maintainable and easily adaptable for the future. Validability and data integrity were of critical importance to Uhlmann for use in critical, regulated infrastructure. In addition, the following requirements were taken into account:
- Creation of an interface standard with simultaneous flexible connection of the machines.
- Implementation of the line and site concept, based on a well-maintainable standard interface architecture.
- Harmonization, typification and contextualization of the heterogeneous data of different machine manufacturers.
- Implementation of the “data integrity by design” approach.
Orchestra is for me the solution to simplify the integration of equipment into the pharmaceutical store floor and to integrate it in a modular and sustainable way.
Implementation of the track and trace tool:
A success story
The software company soffico faced the following challenges when implementing the track and trace tool at Uhlmann:
Maximum heterogeneous environment due to the use of machines from a wide range of manufacturers along production and packaging lines.
Lack of standard for data exchange.
Extremely high implementation and maintenance efforts due to frequently used point-to-point connections of machines and higher-level systems.
Highly regulated work environment – a validated work environment makes changes and adjustments lengthy and expensive.
Heterogeneity in the production environment is amplified by the long lifetime of the validated machine environment, as generations of machines and thus interfaces coexist.
Advantages of Pharma Compliance
through Track & Trace
The successful creation of an integration solution based on Orchestra enables Uhlmann Pac-Systeme to centrally connect and control a wide variety of machines and systems to the Pexcite platform. This created the basis for clear and easy-to-understand operation of the interfaces – especially due to the low-code approach and monitorability. Additional advantages that enable digitalization and connectivity in the company’s own production and ultimately the implementation of the track and trace tool at Uhlmann and numerous other companies:
Reliable traceability is ensured by connecting any machine, equipment and manufacturing steps.
It can be fully demonstrated that all Pharma Compliance rules are being adhered to.
Automation makes data collection and processing easier and more efficient.
The verification and documentation requirements can be met reliably and without problems digitally.
How was the project implemented?
In the course of the solution design, the solution was designed with Orchestra with a special focus on use cases. Thus, a use case was mapped and implemented using various options (OPC UA, REST, AMQP, …). Through partnership development and close cooperation between Uhlmann and track and trace software provider soffico, an integration architecture was created with which systems and machines can be connected across all levels – from the store floor to line and site servers to the ERP. Thanks to a multi-layer scenario architecture, it was possible to implement a service-oriented plug & play concept (SOA).
With Orchestra you build
your own Industrial Suite.
Fully modular and customizable to your IIoT use case.
- Low-code approach thanks to graphical user interface
- Highly scalable through integration of various protocols and formats
- Transparent monitoring of your data flows
Rica Holzmann
