Scale the heights: Why serialisation software is modular and scaleable

Michael Urso, product manager in the Pharma & Packaging Solutions division at Atlantic Zeiser, believes the future of serialisation software is modular and scalable.

The regulations governing the serialisation of medicines are becoming more complex and extensive worldwide. Pharmaceutical companies and packaging service providers are obliged to give consideration to this landscape when selecting an appropriate software and database solution for serialisation and track & trace applications. They must seek to identify a database application that complies not only with all the current international requirements, but also with future needs. The criteria to be applied when selecting a serialisation software are outlined below.

When selecting a suitable serialisation software, it is crucial for pharmaceutical companies and packaging service providers to ensure that it does not only satisfy the existing serialisation regulations, but is also capable of accommodating changing requirements. This applies in particular in view of the increasing complexity and scope of the serialisation projects and specifications that are currently being initiated and implemented in many nations across the globe. It is essential to understand that a supposedly quick and easy solution can have a detrimental impact on productivity, efficiency and security in the packaging and serialisation process. Given the constant consolidation of regulations such as in Brazil or China, it can prove impossible to make changes quickly, and additional costs can be incurred. Preference is to be given to software with a generic system architecture that can expand to accommodate growing requirements and future needs both regarding regulation and workflows.

As a general rule, the serialisation software and database is the most crucial component of a serialisation project and is therefore not to be regarded as merely an adjunct to hardware components or an update for existing programs.

Broad range of applications

The serialisation of drug packaging, which will become mandatory in the USA from November 2017 and in the EU from February 2019, and is already prescribed in Turkey, presents a major challenge to pharmaceutical manufacturers and packaging service providers as regards suitable databases and software solutions.

It is advisable to give closer consideration at the outset to the appropriate configuration of a database solution that is capable of reliably controlling and managing the necessary processes also across multiple lines (ISA-95 Level3), sites or even company-wide (ISA-95 Level 4).

The list of requirements is long. It ranges from the secure generation, management and storage of serialisation and aggregation data, as well as their transfer to national authorities, wholesalers or logistics partners, to the integration of existing or new hardware components and simultaneous production management for multiple lines. At the same time, data security must be ensured and productivity maintained.

Wide-ranging needs

The software architecture of serialisation and track & trace solutions should be sufficiently modular to allow flexible configuration according to the individual user's processes and requirements. Given the certainty of future changes to processes and regulations, the ability to expand functionality and increase the scale of processes (e.g. the administration of hardware used in packaging lines or the amount of aggregation levels) are also highly important factors.

Analysing existing processes

To identify an appropriate software and database solution, the first step should be to conduct an internal examination and analysis of the existing packaging process. Key questions in this connection concern where customer orders and production orders are initiated, and how the serialisation data are reported back to authorities. If this is to be done through an existing enterprise resource planning (ERP) system, the serialisation software must have appropriate interfaces, and a suitable process has to be defined. If an interface to an ERP system is not required, the software should be able to generate the orders and manage them efficiently, even in complex cases.

The complexity of the operation increases as soon as the product has to be exported to several countries where different regulations apply. In some regions the serial numbers might be provided by the authorities, in the EU or US they have to be generated by the serialisation software. In addition, some regions prescribe consecutive serial numbers, while others apply the random principle. The general rule applies that serial numbers belonging to a defined range cannot be issued more than once. As a consequence, the serial numbers contained in the codes must be held on file for a long predetermined period. It may also be necessary to run comparisons in order to recognise duplication.

Secure aggregation at every level

Many countries prescribe not only serialisation, but also aggregation of the secondary packaging into packaging hierarchies in order to allow the seamless tracking of medicines throughout the entire logistics chain – thus accomplishing an end-to-end track & trace capability. This entails comparing the previously serialised individual packs against the serialisation database during the manual or mechanised packaging process in order to produce what are known as parent-child relationships. Also repacking or consignment and returns of goods in the warehouse need to be taken into consideration.

Management platform for production

In the interests of maximising process security, the serialisation software should eliminate a particular source of errors – the human factor – as far as possible. Before the process of serialisation and, if applicable, aggregation can begin, the relevant serialisation data for the individual products should therefore be defined and approved once in a dedicated definition tool that should be part of the software. The next step to generate specific production orders is the manual entry of job variable data such as lot or expiry date.

The capabilities of a prospective software solution become apparent at the latest when production orders are to be allocated to multiple packaging lines at the same time. In this context, the complexity and necessity of a production management platform soon become apparent. Capable serialisation software should be able to oversee the production of a single batch on multiple lines at the same time.

Integrating existing machinery

For reasons of economy the serialisation software like Atlantic Zeiser’s Medtracker should be capable of accommodating hardware components sourced from a wide variety of manufacturers. Bilateral communication between the machines and the software is essential because, apart from the regular transfer of codes and serial numbers, additional information also needs to be shared, such as user data or log files to allow the central generation of audit trails.

In every instance, however, the expandability of a software solution's functions to encompass ISA-95 Levels 3 and 4 should be thoroughly explored and mapped out for the future from the outset. If the chosen software is unable seamlessly to grow along with your needs, significant additional project costs can arise in the medium term. With regards to ISA95 Level4 also the communication with external parties among the logistics chain becomes more and more important. In this context well established interface standards such as EPCIS from GS1 should be part of an appropriate solution.

Managing data with intelligence and legal certainty

The greater the number of lines and ISA-95 Levels that are to be operated by centralised serialisation software, the more important it becomes to implement intelligent user management. User rights are best managed by way of groups to which the individual users can be assigned. In this context of course, compliance with general standards, such as CRF 21 Part 11 of the US Food and Drug Administration (FDA), is to be ensured.

Interdisciplinary project team and time requirements

It is essential that internal processes are thoroughly analysed and all current and future requirements are defined before serialisation software is purchased. Sufficient time should also be allocated to such a complex project, but pressures are likely to increase in view of the approaching effective dates of statutory regulations and foreseeable capacity bottlenecks among software and hardware suppliers. Depending on the ISA-95 Levels that are to be implemented, a period of up to 24 months should be allowed from the start of the analysis to completion of the pilot phase, including procurement, implementation, validation and training both for software and hardware.

Generally speaking, the following holds true as regards the quality of prospective serialisation software: the greater the modularity of its structure and the easier it is to freely define and integrate new workflows and machinery the more future-proof the solution is likely to be.