Serialization That Protects Compliance and Business Continuity
Turn your serialization into a stable, well-governed process that keeps products moving, ensures compliance, and reduces risk – supported by consultants who’ve worked on both sides of the table.
Common challenges in serialization
Unclear ownership and fragmented knowledge
Serialization often spans IT, QA, Supply Chain, and Regulatory, yet few organizations define who truly owns it or ensure effective collaboration across departments. Without clear accountability and structured knowledge sharing, compliance becomes person-dependent, and risk increases when key people move on.
Constant regulatory change and operational risk
Regulations and market requirements evolve continually. Even minor packaging or master data changes can trigger revalidation or shipment delays if governance isn’t in place. Teams spend time firefighting rather than improving.
Complex vendor and partner landscape
Most serialization setups involve multiple systems and providers such as TraceLink or other Level-4 cloud solutions. Without coordination, one small change can ripple through the entire chain, disrupting data exchange, line operations, and compliance reporting.
We solve this by
Governance and process optimization
Structured governance connecting IT, QA, and Supply Chain, ensuring stable operations, clear ownership, and compliant documentation across all markets.
Managed operations
A flexible service model that supplements your internal team. Our specialists monitor daily operations, handle incidents, and drive continuous improvement to keep serialization stable and inspection-ready.
TraceLink and system expertise
Deep experience with TraceLink and other leading serialization platforms. We help configure, validate, and optimize your setup to align with business processes and regulatory requirements.
Training and knowledge retention
Knowledge captured and transferred through training, SOPs and process documentation. Critical expertise becomes organizational, not person-dependent.
What effective serialization looks like
Stable and compliant daily operations
Serialization runs predictably, with proactive issue management and clear governance instead of reactive troubleshooting.
End-to-end visibility and accountability
IT, QA, Supply Chain and other relevant departments all share one truth aligned data, clear roles, and transparent reporting.
Controlled response to change
New regulations, packaging updates, or partner integrations are implemented efficiently and fully validated.
Sustainable, scalable compliance
Your setup evolves with your business, balancing operational efficiency and long-term compliance.
Hear from our clients
Practical results delivered through deep life science expertise.
Why life science leaders choose Epista
Consultants who’ve been on both sides of the table
Our consultants have managed these systems from the inside – they know what works, what doesn't, and how to make serialization stable in practice.
Ahead of regulatory and market change
We stay closely connected to global serialization networks, regulatory bodies, and solution providers so our clients are always prepared for what’s next.
Structured but pragmatic
Proven frameworks and governance applied with flexibility to fit your organization’s culture, maturity, and global footprint.
Long-term operational partnership
From strategic advisory to managed services, we help your serialization setup stay compliant, efficient, and ready for future change.