Serialization System Validation
Serialization is a crucial component of compliance with the FDA’s Drug Supply Chain Security Act (DSCSA) and the EU’s Falsified Medicines Directive (FMD). These regulations require assigning unique identifiers to individual drug packages or units through the application of serial numbers. Serialization is most efficiently implemented using serialization software applications, which like all GxP applications, must be validated.
Serialization systems also enable efficient tracking and tracing of each drug package’s progress across supply chain entities as well as enabling verification checks of the product’s origins and authenticity.
As your organization works to implement a serialization system in time for the FDA’s late 2023 deadline for DSCSA compliance, ProPharma can provide a team of computer system validation experts to support your implementation timeline.
Validate Your Serialization SystemThe validation experts from ProPharma will ensure that your serialization system validation complies with DSCSA, EU FMD, and with other regulations, such as the FDA’s Part 11 and EudraLex Annex 11.
An EU Pharmaceutical manufacturer had recently acquired access to a cloud-based serialization system. They needed to quickly validate the system to meet the compliance deadline for the EU Falsified Medicines Directive.
ProPharma deployed a serialization expert and a team of software validation experts to generate the validation documentation demonstrating the suitability and compliance of the serialization system. The manufacturer was able to meet the FMD requirements well ahead of the deadline.
Ensure Your Serialization System is Compliant
We are available to focus exclusively on your project – with no distractions – to get the validation done quickly. And, we use the latest risk-based validation and computer software assurance approaches, so you can start using your new serialization system soon:
Our team will:
- Provide a suite of risk-based Software Validation SOPs and templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
- Perform a system Risk Assessment
- Develop a Validation Plan that is appropriate for the system risk level
- Work with your team to document User Requirements and Functional Specifications
- Develop Test Plans and Deliver Validation Protocols (e.g., IQ, OQ, PQ)
- Execute the Validation Protocols and provide supporting test documentation including a Trace Matrix
- Deliver an inspection-ready Test Summary and Validation Report
If your serialization system vendor has provided some of the validation documentation, we will leverage this documentation to further expedite the process.
Get Help with Your Serialization System Validation Project
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