For companies working in regulated environments, validation is non-negotiable. What happens when the tool you’re relying on starts becoming part of the problem. Delivering meaningful value, or simply the illusion of control?
Feedback from users often highlights that TraceLink’s validations are superficial, designed more to satisfy system checks than to reflect the true complexity of operational compliance. That is a significant risk, especially if companies assume that “green check marks” mean everything is fine.
1. Validation That Misses The Point
For environments with complex compliance requirements, TraceLink’s validation often fails to catch real-world, nuanced issues. It is surface-level, and that makes it risky.
In industries like pharma or life sciences, compliance isn’t just about confirming file formats or presence of fields. It’s about business logic, conditional rules, serialised traceability, and ensuring end-to-end process integrity. A high-level check may validate structure, but miss whether the content actually makes sense – leading to false confidence. Surface-level tools miss critical failures and might:
– Approve transactions that violate DSCSA/Annex 11 rules.
– Miss broken handoffs between systems.
– Ignore the sequencing of events like commissioning before shipment.
Silent failures usually only surface during audits or product recalls—when it’s too late.
2. False Positives or Negatives
A tool that frequently flags correct data as invalid or misses actual problems undermines user confidence and introduces dangerous blind spots.
3. Manual Effort Still Required
Despite being marketed as automated, users often need to manually verify or double-check data. The result? Inefficiency and duplicated effort.
4. Cost v Benefit
TraceLink isn’t cheap. If the validation tool doesn’t clearly prevent errors or compliance issues, it can feel like you’re paying for something you don’t really use.
5. Limited Customisation
Validation processes must adapt to your internal systems and workflows. When a tool is rigid or generic, it adds noise—not value.
6. Redundant with Existing and New Systems
Many companies already perform validation within ERP or QA systems. Adding another layer—without real benefits—only creates confusion.
Risk isn’t just about what a tool misses – it is also about what it promises and does not deliver.
Are you validating effectively, or just checking a box?
If you are relying on TraceLink validation, ask yourself: Are we getting real assurances, or just a false sense of security?
We’d love to hear from others. Is this your experience too?