Essential
Everything you need to get started.
Starting from€299
Included
Get a quote
- Data logger rental
- Calibrated data loggers
- Calibration certificates
Audit-ready mapping protocol and report
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.
What you receive
- Mapping protocolScope, risk assessment, justification of measurement points and pre-established acceptance criteria.
- Mapping reportAnalysis, graphs, hot and cold spots, deviations, conclusion and advice for the permanent monitoring position.
- Your own document templateWith version numbering and revision history, ready for approval within your quality system.
- Walkthrough of the dossierSo you can explain the justification yourself during an audit.
Temperature mapping, your way.
Most popular
Professional
Expert support from start to finish.
Starting from€599+ logger rental
Included
Get a quote
- Data logger rental
- Calibrated data loggers
- Calibration certificates
- Mapping protocol
- Data analysis
- Hot & cold spot identification
- Expert mapping report
- Ready for audit
Complete
Fully managed, from start to finish.
Starting from€999+ logger rental
Included
Get a quote
- Data logger rental
- Calibrated data loggers
- Calibration certificates
- Mapping protocol
- Data analysis
- Hot & cold spot identification
- Expert mapping report
- Ready for audit
- Complete on-site execution
Measurement data is not yet a dossier
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.
Two documents, one dossier
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.
The mapping protocol
Establishes before measurement what you want to demonstrate and what the outcome must meet.
- Scope: which space, which equipment, which range
- Risk assessment of doors, air flow and loading
- Number of measurement points with justification per position
- Measurement duration, interval and seasonal conditions
- Acceptance criteria and handling of deviations
- Roles: who executes, reviews and approves
The mapping report
Shows after measurement what was measured and whether the criteria were met.
- Execution and deviations from the protocol
- Analysis per measurement point, graphs and distribution
- Demonstrated hot and cold spots
- Assessment against acceptance criteria
- Root cause analysis of deviations and CAPA initiation
- Conclusion, monitoring advice and appendices
Which framework applies?
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.
EU GDP
For distribution and storage of medicines. Requires demonstrably suitable storage conditions and justified sensor placement for monitoring.
EU GMP, Annex 15
For qualification and validation in production environments. Determines the structure of protocol, execution, report and handling of deviations.
WHO and ISPE
Practical guidelines for mapping storage spaces and the cold chain. Form the basis for measurement duration, measurement point density and seasonal coverage.
HACCP and food
For chilled and frozen storage outside pharmaceuticals. The methodology is the same; criteria and justification differ.
ISO/IEC 17025
Applicable to the calibration of the data loggers used. Certificates are included as appendices in the dossier.
Your own quality system
Internal SOPs, templates and approval routes often take precedence. We align with these rather than introducing a separate format.
Two ways we can deliver this
We prepare the documentation for you or review what you have already prepared.
We prepare protocol and report
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.
- Protocol before measurement, report after completion
- Risk assessment and justification per measurement point
- Advice on the permanent monitoring position
- Price is on top of logger rental
We review your documents
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.
- Missing or retroactively filled acceptance criteria
- Measurement points without justification or risk analysis
- Deviations without root cause analysis or follow-up
- Monitoring position that does not follow from the measurement
From scope to approved dossier
The first two steps happen before a single logger is hung. That's where the audit value is created.
1
Intake and scope
Which space, which temperature range, which framework. We determine together which guideline applies and which risks matter.
2
Protocol for approval
You receive the protocol with measurement points, justification and acceptance criteria. Measurement starts only after your approval.
3
Analysis of measurement data
Assessment against criteria, identification of hot and cold spots and evaluation of any deviations.
4
Report and handover
The report with conclusion, appendices and monitoring advice. We review it with you so you can explain it yourself during an audit.
When is this needed?
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.
Audit or inspection coming up
You don't want to discover that the evidence is missing while the inspector is watching.
Finding from a previous audit
About temperature control, justification of measurement points or the monitoring position.
Periodic requalification
The previous mapping has expired and suitability must be demonstrated again.
After a change or failure
A change to cooling, layout or use changes the temperature distribution.
New or renovated storage
The space is coming into use and suitability has not yet been demonstrated.
Contractual requirement
A client requests evidence, for example when outsourcing storage or distribution.
Request advice for your dossier
Frequently asked questions about protocol and report
About the content of the documents, the guidelines we follow, the lead time and costs.
What is the difference between a mapping protocol and a mapping report?
The protocol is drawn up before the measurement and defines what you want to demonstrate: scope, measurement points, measurement duration and acceptance criteria. The report follows after the measurement and shows whether those criteria were met, including analysis, deviations, conclusions and appendices. Together they form one dossier in which every conclusion can be traced back to a criterion that was established in advance.
Can you prepare a report based on a measurement that has already been carried out?
Often yes, but with a caveat. If there was no protocol with pre-established acceptance criteria, we cannot establish them retroactively without mentioning that. We then provide a report that describes what was measured and what can and cannot be concluded from it. For a subsequent measurement, we prepare the protocol in advance.
Can you assess our existing protocol or report?
Yes. We review your documents against the framework applicable to you and indicate where the evidence is too thin for an audit: missing acceptance criteria, measurement points without justification, deviations without follow-up or a monitoring position that does not follow from the measurement. You receive point-by-point feedback with recommendations. The price depends on the scope and is on request.
Do you follow our own document template?
Yes, if you wish. Many organizations have their own document format, numbering and approval route. We align with that. If you don't have a template, we provide our own format.
Who signs and approves the dossier?
We sign for the preparation and the substantive justification. Approval remains with your own QA or responsible official, because responsibility for storage conditions lies with your organization.
Which guidelines do you follow in preparation?
It depends on your situation. For distribution and storage of medicines, EU GDP is leading. For production environments, EU GMP Annex 15 applies. We also use practical guidelines from WHO and ISPE for measurement duration, measurement point density and seasonal coverage. Outside pharmaceuticals, we work according to HACCP. Which framework is leading and how strictly it is interpreted, we determine together during the intake.
How long does it take before we have the dossier?
We usually provide the protocol within a few working days of the intake. The subsequent lead time is determined by the measurement duration, which follows from the guideline and the type of space. After receipt of the measurement data, the report follows.
What does an audit-ready protocol and report cost?
Preparing protocol and report based on your own measurement starts from €599 excl. VAT, on top of the data logger rental. A review of existing documents is on request. The final price depends on the number of spaces, the applicable framework and the scope of the measurement.
Want to read the background first?
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 structureDescribe your situation
Tell 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.