Serialization compliance is ongoing. Your operating model should be ready.
AssureTrace brings specialist managed compliance services together with established SoftGroup serialization technology, helping pharmaceutical companies organise the work that continues after go-live.
Service-led. Technology-powered.
The first serialization milestone was implementation. The continuing challenge is running compliance, day after day.
The first generation of serialization was built around implementation deadlines. For established companies, those programmes may be complete, but the recurring operational workload remains.
Regulations change. Markets expand. Trading partners onboard. Exceptions need investigation. Verification requests need answers. Releases require validation.
Exceptions, partner relationships, validation, reporting and controlled changes continue after go-live.
You retain oversight and regulatory accountability. Your contracted service provider handles the agreed operational work, supported by established SoftGroup technology.
Specialist support, with your team in control.
The pharmaceutical company retains governance and regulatory accountability, while managed support takes on defined recurring operational work.
Access scarce serialization expertise
Access specialist serialization support without having to build the entire function in-house.
Reduce key-person dependency
Documented processes and specialist support can strengthen continuity as teams, regulations and partner requirements change.
Make recurring operations more predictable
Defined scope, service reporting, escalation and governance make ongoing compliance work more visible and manageable.
Understand your full operating cost
Compare software and service costs alongside staffing, validation, integrations and migration. Identify where managed support could reduce duplicated effort.
Built on established SoftGroup technology.
SoftGroup provides the underlying platform and technology capabilities behind AssureTrace, including established serialization experience, regulatory connectivity and supported interoperability.
Built on SoftGroup’s platform and more than two decades of experience.
Graham Clark
Director & CRO | AssureTrace
Graham Clark brings 23 years of experience in healthcare serialization and track & trace, spanning the introduction of the EU Falsified Medicines Directive, the US Drug Supply Chain Security Act and the expansion of national traceability regimes worldwide.
Graham works with pharmaceutical companies and service partners to address the ongoing challenges of serialization compliance, from provider change and commercial launch to daily operations.
His focus is practical: help teams access the specialist support they need while keeping oversight and control.
“Regulators expect you to own the outcome. They do not require you to staff the keyboard.”Talk to Graham
Specialist delivery on an established technology foundation.
AssureTrace brings specialist managed services together with SoftGroup’s established serialization platform to support the daily work that continues after implementation.
SoftGroup provides the technology and engineering experience. Contracted specialist providers deliver the operational services agreed with each customer.
The result is access to proven technology and specialist support, with clear responsibilities and customer oversight.
Which serialization responsibilities should still sit inside your team?
Discuss your current operating model, recurring burden and where managed support could make the biggest difference.