Serialization deadlines in the U.S. and European Union have finally passed. Now what? As serialization mandates become increasingly complex, pharmaceutical companies are scrutinizing whether their current serialization software is the best long-term solution. However, most regulations―including the Drug Supply Chain Security Act (DSCSA)―have required minimal system capabilities: generating serial numbers, allocating serial numbers to partners and showing that the commissioning data has been received. During the next 6-12 months, serialization systems will be rigorously tested for their ability to handle aggregation data, facilitating integration with distribution (internal and third-party logistics providers), integration with downstream customers and complicated regulatory reporting requirements, such as the European Union’s Falsified Medicines Directive (EU FMD) and the Russian Federal Law No. 425-FZ.
With the DSCSA and EU FMD now in effect, many players in the pharmaceutical industry have been feeling the pain of serialization solutions that are falling short. With the largest packaging line installation base of any vendor, OPTEL often hears about these struggles: over-promised and under-delivered capabilities; high rates of issues and bugs; and the unexpected need to pay for costly “optional” tools and third-party resources to maintain a validated, high-performing solution.
As a result, pharma manufacturers and CMOs are looking for better options.
We understand that the last thing pharma companies want to do right now is to start over with a new serialization platform. Unfortunately for some, making the switch is necessary. Non-compliance with the DSCSA will directly impact your company’s bottom line as it is no longer acceptable to ship serialized items when your serialization system is failing.
Many organizations were hesitant to change serialization and traceability vendors in the months and weeks before the DSCSA deadline, and understandably so. But with the serialization deadlines behind us, companies can now focus their attention on longer-term, strategic decisions.
As the only company with the ability to provide true end-to-end traceability, OPTEL is in a unique position to provide a better option. The good news is that your efforts up to this point are not lost. In fact, OPTEL’s approach to serialization platform conversion is centered on our reuse of any components that still provide value, while minimizing risk, cost and resource strain to your organization and your partners during the conversion process.
System conversions are never as easy as flipping a switch. The most important requirement for any pharma company considering a serialization software change is that there are zero interruptions to your business operations.
Our approach to system conversions is based upon a tested methodology. We assess both the business landscape such as current markets, current partners, supply planning, resource availability, as well as technical aspects: data migration from the current serialization vendor, current integrations to partners, regulatory reporting and user reporting.
OPTEL’s project managers collaborate closely with teams from your serialization, supply chain and planning departments to segment the conversion scope into workstreams that minimize the risk to your operations and technical capabilities.
Our analysis begins by organizing partner organizations, starting with packaging sites and CMOs, by the markets they serve and associated serialization regulations. The market(s) served by the highest number of single-source partners (e.g., packaging sites/CMOs that only serve a particular market) are considered the lowest risk and are prioritized for conversion.
We segment by market and partners to allow for a seamless, phased conversion experience. After the first market segment is converted to OPTEL’s serialization solution, both the legacy serialization system and the OPTEL platform can run in parallel. This ensures no interruption to your business operations.
Once markets, partners and products are categorized, OPTEL’s project managers develop a comprehensive project plan that translates the scope segments into project workstreams. Our planning process takes into account packaging schedules, regulatory deadlines and legacy provider contract timelines.
The OPTEL solution architect is responsible for working directly with your partners and the legacy provider to exchange technical specifications and define the technical design and approach to determine what changes are required in terms of data formatting or data communication. Our goal is to find the integration approach that most minimizes impact to the partner organization while also ensuring the best long-term solution for you. Often this includes transitioning away from a legacy provider’s proprietary format in favor of the most widely adopted serialization integration standard, which is GS1’s EPCIS.
OPTEL applies the same rigorous validation support to system conversions as we do to our initial platform deployment by providing the base foundation for quality documentation (e.g., user requirement specifications, functional specifications, CSDS, installation qualification/operational qualification protocols). Most importantly for conversion customers, OPTEL offers the same commitment to ensure that our platform maintains a validated state through all releases and new partner integrations going forward.
By moving to the OPTEL serialization platform, manufacturers and CMOs will recognize immediate benefits.
To access the full version of the White Paper, click here.