For pharmaceutical and medical device companies, end-to-end traceability has become a critical regulatory and operational requirement. Track & Trace systems are no longer optional digital enhancements—they are fundamental to ensuring patient safety, supply chain security, and compliance with global Good Manufacturing Practice (GMP) and product identification regulations.
Two key regulatory frameworks underpin the global importance of serialisation and traceability:
- The US Drug Supply Chain Security Act (DSCSA)
- The EU Falsified Medicines Directive (EU FMD 2011/62/EU)
The DSCSA, implemented by the US FDA, requires pharmaceutical manufacturers, wholesalers, dispensers, and repackagers to establish an electronic, interoperable system to identify and trace prescription medicines at the unit level. The DSCSA requirements have been enforced since 2025, and mandate full electronic interoperability across the supply chain, enabling rapid detection and removal of suspect or illegitimate products.
Similarly, the EU FMD requires prescription medicines to carry a unique identifier and anti-tampering device, with verification performed at dispensing points through national verification systems connected to the European Medicines Verification Organisation (EMVO). This framework is designed to prevent falsified medicines from entering the legitimate supply chain.
Together, these regulations have fundamentally reshaped how pharmaceutical supply chains operate, making validated Track & Trace systems essential infrastructure rather than optional technology.
With increasing global regulatory alignment around serialisation and traceability, organisations must be able to track each product unit across the entire supply chain—from manufacturing and packaging through to distribution and dispensing.
These systems deliver critical capabilities, including:
- Real-time visibility of product movement across global supply chains
- Enhanced patient safety through counterfeit prevention and recall readiness
- Strengthened supply chain security and regulatory compliance
- Protection of sensitive product and patient data through controlled system access
As supply chains become increasingly interconnected and digitally enabled, organisations rely heavily on validated software platforms to manage serialisation, aggregation, and regulatory reporting. This places Computer System Validation (CSV), data integrity, and lifecycle management at the core of compliance strategies.
SeerPharma is currently engaged to provide Computer System Validation (CSV) support, periodic review services, and data management expertise for multiple Track & Trace and serialisation platforms used within a global pharmaceutical manufacturing network.
The engagement covers:
- Validation lifecycle support for the RFXCEL Traceability System
- Periodic system review and validation maintenance activities
- Management and retention of historical serialisation data from the TraceLink platform
These activities ensure ongoing compliance, data integrity, and regulatory readiness across multiple digital supply chain systems.
SeerPharma is providing structured support for the periodic review of the RFXCEL Serialisation System, a full-stack traceability platform that enables real-time global supply chain visibility and supports product safety, security, and operational efficiency.
The periodic review is designed to assess system performance, confirm continued validation status, and evaluate the impact of vendor software updates on the validated state of the system.
The initial phase includes a comprehensive review of system and validation artefacts, including:
- Review of the User Requirements Specification (URS) against current system functionality
- Review of existing validation documentation
- Review of vendor release notes for recent version changes
- Review of vendor release notes for the latest available version
- Impact assessment of software changes on validated functionality
- Gap analysis and compliance evaluation
SeerPharma delivered a detailed gap assessment report forming the core of the periodic review package. The report included:
- A comparison of validated versus current system functionality
- Assessment of the impact of system changes on the validated state
- A recommendation on validation strategy options, including:
- Maintaining the current validated version, or
- Upgrading and revalidating to the latest version
The recommendation also included indicative time and cost implications to support informed decision-making and lifecycle planning.
Following completion of the periodic review, SeerPharma is also providing direct validation support for the currently installed RFXCEL system version as part of an ongoing validation lifecycle activity.
This work builds on the earlier gap assessment and ensures the system remains in a validated and compliant state.
SeerPharma’s validation scope includes:
- GAMP categorisation assessment using client templates
- Preparation of a Validation Plan defining roles, responsibilities, and deliverables
- Development of a Validation Protocol referencing:
- Gap assessment findings
- Vendor documentation
- Existing User Acceptance Testing (UAT) scripts
- Execution of existing validated UAT scripts
- Preparation of a formal validation report and system release statement framework
The completed validation package forms a key component of the periodic review deliverable and supports continued regulatory compliance of the system.
In parallel, SeerPharma is supporting the management and retention of historical serialisation and Electronic Product Code Information Service (EPCIS) data from the TraceLink system previously used by the client.
This activity is essential for ensuring long-term regulatory compliance under DSCSA and EU FMD expectations, maintaining audit readiness, and preserving end-to-end supply chain traceability records.
SeerPharma provides both advisory and execution support, including:
- Ad-hoc consultancy on data extraction and retention strategies
- Guidance on compliant archiving and long-term retention practices aligned with regulatory expectations
- Verification of data integrity, completeness, and security within the retained repository
- Preparation of a formal Data Extraction Protocol, including:
- Step-by-step extraction methodology ensuring data integrity
- Defined verification procedures to confirm completeness and accuracy of extracted data
The protocol is delivered for client execution, ensuring a controlled, auditable, and compliant data migration and retention process.
Through this engagement, SeerPharma is supporting the client in maintaining a robust, validated, and compliant Track & Trace ecosystem across multiple platforms and lifecycle stages.
From periodic system review and validation of RFXCEL to structured data retention support for data generated in the legacy TraceLink system, these activities ensure that critical serialisation data remains:
- Validated
- Traceable
- Secure
- Compliant with global regulatory frameworks including DSCSA and EU FMD
This approach strengthens supply chain integrity while enabling the organisation to respond effectively to evolving regulatory requirements and operational challenges.
This engagement highlights SeerPharma’s deep capability in supporting validated digital systems within regulated environments, including:
- Computer System Validation (CSV) and Computer Software Assurance (CSA)
- Track & Trace and serialisation system validation
- GAMP 5-based risk assessment and lifecycle validation
- Periodic review and validation maintenance
- Data integrity and EPCIS compliance
- System integration and interface validation
- Data migration, extraction, and retention strategies
- Regulatory compliance aligned with DSCSA and EU FMD requirements
SeerPharma continues to support pharmaceutical and medical device organisations in ensuring that complex digital supply chain ecosystems remain compliant, resilient, and fit for purpose throughout their lifecycle.
Learn more about our CSV/CSA services.
Contact us to learn how we can support your organisation with Track & Trace validation and compliance projects.
