Temperature mapping is only useful when backed by a dossier an auditor can follow. We establish the measurement setup and acceptance criteria in a mapping protocol before the first logger goes up, then convert your measurement data into a report with analysis, deviations, conclusion and appendices. Have you already prepared documents? We assess them for audit readiness. From €599 excl. VAT.
Most organizations we speak with do have measurement data. An export from the logger software, a folder with graphs, sometimes a summary in an email. What's missing is the paperwork around it: why the loggers were placed exactly there, which limits applied in advance, what that spike on day three means, and who reviewed it.
That's precisely where audits get stuck. An inspector doesn't ask for your graph, but for the justification. Without pre-established acceptance criteria, the outcome determines the criterion after the fact, instead of the other way around. We therefore deliver two documents that align with each other: the protocol establishes in advance what you want to demonstrate, the report shows afterwards whether you succeeded.
The protocol is approved before the measurement. The report then explicitly references it, so every conclusion can be traced back to a criterion that was already established.
Establishes before measurement what you want to demonstrate and what the outcome must meet.
Shows after measurement what was measured and whether the criteria were met.
We work brand-neutrally and follow the framework that applies to your organization. During intake, we determine together which guidelines are applicable and how strictly they should be interpreted. That determines the protocol structure.
For distribution and storage of medicines. Requires demonstrably suitable storage conditions and justified sensor placement for monitoring.
For qualification and validation in production environments. Determines the structure of protocol, execution, report and handling of deviations.
Practical guidelines for mapping storage spaces and the cold chain. Form the basis for measurement duration, measurement point density and seasonal coverage.
For chilled and frozen storage outside pharmaceuticals. The methodology is the same; criteria and justification differ.
Applicable to the calibration of the data loggers used. Certificates are included as appendices in the dossier.
Internal SOPs, templates and approval routes often take precedence. We align with these rather than introducing a separate format.
We prepare the documentation for you or review what you have already prepared.
You perform the measurement yourself with rented loggers. We provide the protocol in advance with the measurement setup and process your measurement data into the complete report.
Have you already prepared a protocol or report? We review it against your framework and indicate point-by-point where the evidence is too thin.
The first two steps happen before a single logger is hung. That's where the audit value is created.
Which space, which temperature range, which framework. We determine together which guideline applies and which risks matter.
You receive the protocol with measurement points, justification and acceptance criteria. Measurement starts only after your approval.
Assessment against criteria, identification of hot and cold spots and evaluation of any deviations.
The report with conclusion, appendices and monitoring advice. We review it with you so you can explain it yourself during an audit.
In practice, the request for an audit-ready dossier almost always comes at one of these moments. Are you unsure if your current dossier is sufficient? The audit readiness check runs through the components an auditor typically requests in just a few minutes.
You don't want to discover that the evidence is missing while the inspector is watching.
About temperature control, justification of measurement points or the monitoring position.
The previous mapping has expired and suitability must be demonstrated again.
A change to cooling, layout or use changes the temperature distribution.
The space is coming into use and suitability has not yet been demonstrated.
A client requests evidence, for example when outsourcing storage or distribution.
About the content of the documents, the guidelines we follow, the lead time and costs.
Our knowledge base contains the substantive explanation: what belongs in each document, how protocol and report relate within qualification and validation, and which mistakes are most common.
Read the explanation View protocol structureTell us briefly which space this concerns, which framework applies to you and whether you measure yourself or have documents already prepared. You'll receive a proposal with the setup and a price, without an extensive advisory process beforehand.