Anyone who manages diagnostic medicine operations knows the drill well: as soon as the accreditation audit date approaches, teams go into high alert. The race begins to check physical files, fill in gaps in contingency spreadsheets, and hope that no non-conformities have gone unnoticed at the sample collection stage.
This pre-audit stress reveals a classic symptom: when quality control relies on manual or paper processes, compliance becomes a temporary effort, not an operational habit.
The truth is straightforward: a laboratory of excellence should not need to “prepare” for an audit. The process needs to be auditable by definition, at every moment.
The end of paper-based evidence
In the pre-analytical phase—where up to 70% of diagnostic errors occur—demonstrating compliance has always been a bottleneck. How can one demonstrate to an auditor, with mathematical precision, that tourniquet time limits were observed, that sample homogenization followed protocol, or that the sample's chain of custody remained intact from the bedside to the centrifuge?
With eTrack, Greiner Bio-One’s aim has always been to turn compliance into an automatic byproduct of work well done:
- Immutable Digital Trail: Every scan, timestamp, and tube validation generates a real-time digital record. There is no room for retroactive entry or data loss.
- Active Protocol Control: The system prevents the data collector from skipping mandatory steps. The safety interlock acts at the source, eliminating non-compliance before it becomes a formal audit non-conformity.
- Evidence in Just a Few Clicks: Instead of opening dozens of folders containing physical proof, the manager generates comprehensive traceability and process history reports directly from the dashboard.
Accreditation as a culture, not an event
Programs such as PALC, ONA, and ISO do not merely seek signed documents; they evaluate the maturity and actual safety of care processes.
When technology takes responsibility for recording and safeguarding the pre-analytical workflow, the team gains peace of mind and management gains predictability. Audits cease to be a source of tension and become just another ordinary day of safe operations.
How does your laboratory handle pre-analytical evidence today: with folders and paper, or with real-time traceable data?
A hug,
Leonardo Lippel Rodrigues
Sales and Technology Manager