Author: Steve Tallant, Senior Director, Market Development, Systech
First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging—regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Manufacturers who have worked through compliance with the US DSCSA and EU FMD are well aware of this.
Regulations differ between markets and can change often enough, requiring that regulatory professionals are prepared to adjust processes, procedures and filings to keep up. Looking at the current news, manufacturers developing COVID-19 vaccines and medications need to implement a flexible, configurable serialization platform to ensure compliance and deliver these critical products to different markets at a speed never before required.
At the line level, there are complexities around manual versus automated lines, existing versus new lines, and the varied nature of packaging equipment with numerous original equipment manufacturer (OEM) solutions in the industry. At the site and enterprise levels, the electronic serialized product data not only needs to match the physical, but must also be tracked in the supply chain through multiple channels and handle supply chain events like returns, damages, recalls, etc.
Serialization is now a four-level software stack. Manufacturers need vendors that can provide the full range of bottom-up device- and line-level software as well as integrated top-down enterprise- and site-level software. A single-vendor approach to addressing these levels will ensure tight integration of the solution, facilitate data communication and decrease overall project risk.
A Proven Approach
Systech has developed products for the pharmaceutical, medical device, healthcare and other industries for more than three decades. Productized, configurable and expandable packaging and serialization solutions have been a key asset in helping clients successfully implement programs to meet the changing market requirements, compliance and a broad range of packaging environment challenges.
Systech does two main things to facilitate our customers' continued regulatory compliance:
- Our solutions are built on a flexible, configurable architecture. This means that most regulatory changes can be accommodated with simple configuration adjustments, without the need for any bespoke software.
- We continually monitor for new regulations and changes to existing regulations. When product changes are necessary to meet the new requirement(s), we make sure the changes are available in time. This includes our line-level, site-level and enterprise-level serialization and tracing products.
Systech has gone through the work of taking our experience with hundreds of customers and thousands of line implementations and putting it into a repeatable methodology for the myriad of environments encountered.
Systech produces “off-the-shelf”, configurable product that does not rely on customized or made-to-order components. It is considered a GAMP5, Category 4 Configured Product. The benefits of deploying configurable rather than customized software are well documented. These benefits are accentuated in environments where the required functionality of this software is subject to change.
Configurable serialization software is designed with elements that can be assembled and realigned to quickly accommodate changing demands. In contrast, customized solutions are rigid, making them difficult and costly to modify. When requirements change with customized solutions, it will be necessary to reengage vendors and incur expensive rewrite, revalidation and retraining costs.
Systech has developed a library of prepackaged modules to meet a wide array of packaging scenarios and serialization requirements. These modules can then be added to the core solution to meet the requirements of the packaging line. Each module can be standalone or added with other modules allowing clients to design and build a solution for now that is expandable over time.
Modules can be reused across multiple deployments to minimize risks, costs and downtime. This patented software platform covers the full stack from Level 1 to Level 4 for unbeatable ease of implementation and speed to compliance. Our equipment-agnostic, configurable solutions give you flexibility to adapt to new regulations cost-effectively without customizing for every change.
We encourage you to learn more about configurable serialization software. This combination of out-of-the-box software, documented processes and prepackaged configurations ensure that new serialized lines are up, running and compliant in the timeframes you need to meet.