How to pull out the documentation
What you need to be able to present at an inspection, and how to get it out of the system without having to search.
What do you need to be able to present at an inspection?
In practice, four things. A specific reading at a specific time. The history of a measuring point over a period. What happened during a deviation, meaning who was notified, when it was acknowledged and what was done. And the calibration status of the sensor the reading comes from.
All four are in the system and can be exported as PDF or CSV. What takes time at an inspection is rarely finding the figures. It is finding them quickly enough that the conversation does not stall.
That is why it matters that the measuring points are named after department and room rather than serial number. A question about refrigerator 4 in the pharmacy should not require someone to look up a serial number first.
We deliver the system and the reports. The regulatory preparation and assessment lie with you or your QA.
The four things you will be asked about
A specific reading
Date and time at a particular measuring point. Pulled directly from the graph.
History for a period
Min, max and average plus raw data. Exported as PDF or CSV.
Handling of a deviation
Who was notified, when it was acknowledged, and what was done.
Calibration status
Certificate with serial number and date, and an interval that has been met.
Naming
Measuring points named after department and room, not serial number.
Access and roles
Who has access to what, and how it is controlled.
Prepare it before, not during
What gives peace of mind at an inspection is having pulled the reports once in advance. Then you know how long it takes, what they look like, and whether the naming makes sense to an outsider. We are happy to go through it with you once the system is set up, so you have tried it before it matters.
Frequently asked questions
How long does it take to pull a report?
A couple of clicks. Choose measuring point and period, and export it as PDF or CSV.
Can we pull a report for a whole department?
Yes. Measuring points can be grouped by site, department and room, and the report can be taken at each level.
What if the inspection asks about something several years back?
Data is stored for as long as your procedures require, and can be exported so it can be read independently of the system.
Can you help us prepare for an inspection?
We can show what the system can document and go through the reports with you. The regulatory preparation lies with your QA.
What if there is a gap in the documentation?
Then it is better to know about it in advance and have an explanation than to be caught by surprise. The system gives technical alarms precisely to avoid gaps.
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