Software Best Practises: Implementation & Data Integration
"I don’t believe that the serialisation topic will end once the deadline is met in Europe. It’s really only the beginning. The use of the data will continue and in 10, 20 years from now people will be doing different things with the data than we ever imagined.” Michael Kinsella of Servier
Industry stakeholders have insisted that it could be a costly mistake to view serialisation as a project which only concerns engineering matters. As serialisation data is unique to the pack it requires not only the deployment of new treatment but also expanded staff investment and stakeholder engagement. Therefore, “To characterize it as an engineering issue is therefore to grossly underestimate its consequences, which touch virtually every business function in pharmaceutical manufacturing.”2
The updating of hardware for packaging lines may on first appearances seem to be a usual project comprising of routine timescales and considerations. However, some cases in the market have conveyed that installing and commissioning integrated serialisation ready hardware ends up being considerably more complex than first assumed. 2 New equipment capabilities have to be met in response to data requirements– including multi-substrate inks for TIJ printers and printer abilities to perform to aggregation and verification.
Effective data management is imperative to achieve regulatory compliance with a serialisation programme. Non-standard data exchange and integration methods are seen as one of the biggest hurdles in serialisation compliance.4 These projects will also incur a surge in the amount of data shared between trading partners, with the volume of data units being determined by the length of the supply chain in question.
In light of the data responsibilities expected within serialisation projects, Pharma IQ consults with a selection of experts on software best practices - data integration and implementation.
Clear map of architecture:
Pharma firms should have a clear map of their current and their target architecture, due to the evolving ecosystem that operates in many pharma companies. Michael Kinsella, Program Director, Serialisation & Traceability at Servier notes that the pharma firm is currently rolling out a SAP implementation at their main sites simultaneously alongside other rationalisation projects concerning historical IT systems.
So, here, a clear roadmap is imperative to ensure Servier is synchronized with their master data requirements to fulfill the needs in a timely fashion.
In response to partnership interaction with CMOs, Michael Kinsella from Servier noted: “The CMO area is quite tricky and it’s often left until the last step because there is a lot of hesitancy about specifying responsibilities. Who’s going to pay for the interfaces? You may even have equipment that needs to be put into the CMOs to perform some of the data exchanges, you may need scanners, you may need relabeling, you may need reprinting or re-aggregation capabilities in order to be able to send data back to a mother system and to maintain the integrity. So it’s really quite complex.” He adds that assessing CMO interaction is often underestimated. CMOs usually wait for the client to explain their needs, as it is the pharma companies who hold the marketing authorizations that are under the obligation to ensure boxes leave the factories in a conforming manner.
Depending on the responsibility or the contract held between various partners or the pharmaceutical company, it is not always completely clear what kind of investments the CMOs need to make and the interfaces they are responsible for.
“I think the first steps are not the specification of the interface itself – but more mapping out the relationship and the responsibility the business needs.”- Michael Kinsella
This will involve categorizing the partners the pharma firm has, the type of CMOs and their responsibilities and requirements. Different arrangements may occur according to the authorisation of a product or the delegation of responsibility in the production, packaging and distribution of a product. Michael notes that in some cases pharma firms may decide not to integrate their systems into, or to interface with the CMO’s systems or exchange data. They may simply connect to the national database to which the data is transmitted to. In other cases, there may be a business need to exchange data to facilitate certain business activities, especially where the product is still in the possession of the pharma firm. “If the product has left their possession or has been sold, the responsibilities for the data integrity or data exchanges change somewhat.”
Other Subjects discussed in this ebook include:
- Test your CMO’s readiness
- Alignment with software selection
- Interface adaptability
- Maintain and manage your open communication:
Integration with legacy tech systems
Long term vision strategies & concerns
- Visibility & optimisation
- Consolidation to reduce running costs
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