Documentation & Software
Documentation & software: paperless & audit-proof
An end to paper chaos: how to document every batch digitally, RKI-compliant and directly in your practice software.
Germany Austria Switzerland
Short answer
With SteriTrace you document batch release paperlessly and export it to any common practice software. That saves hours every week — and makes inspections stress-free.
Understanding digital documentation
From how it works to the link with your software — everything important at a glance.
About the SteriTrace software connection
Paperless RKI documentation that any practice software understands.
Learn morePractice software compatibility
Which practice software works with SteriTrace.
Learn moreDocumenting instrument reprocessing
Batch control, release and audit-proof documentation done right.
Learn moreYou don't have to manage this alone
The most common concerns of our customers — and how we resolve them.
„What exactly is SteriTrace?“
A paperless batch documentation on the touchscreen — released in 3 clicks, even for non-IT-savvy staff.
„Will it fit my IT?“
Export to any practice software via network folder/FTP — and everything runs completely offline if you prefer.
An end to paper chaos.
Paperless, audit-proof batch documentation that any practice software understands. Hours saved — every week.
What our customers say
4.9 out of 5 stars on Google — from verified reviews.
MK
Maud Kolb · Google
„Fast delivery, good advice, great price. Maintenance and validation nearby. I'm happy. Thank you!“
SG
Stephanie Grebe · Google
„I was very positively impressed by the very good, honest and patient advice. I felt well looked after.“
4.9 out of 5 on Google Class B medical device · EN 13060 · TÜV SÜD 39 locations + 150 partners DACH Family-run since 1957
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Frequently Asked Questions
Documentation & Software – key questions answered clearly.
What is SteriTrace?
SteriTrace is the paperless documentation solution from Steri24 for batch release and the documentation of instrument reprocessing. You release each batch in just a few clicks on the touchscreen and do away with handwritten paper chaos.
How does digital batch documentation with SteriTrace work?
After each sterilisation cycle the record is captured automatically, checked on the touchscreen and released in a few clicks. The release decision is stored with reference to the batch and the releasing person and is available audit-proof at any time.
Is SteriTrace also suitable for non-IT-savvy staff?
Yes. The release takes about three clicks on the touchscreen and is deliberately kept simple so that staff without IT experience can also work with it confidently.
Can the autoclave be connected to my practice or hygiene software?
Yes, the Premium autoclaves in particular can be connected to common practice and documentation software via LAN/WLAN or a serial interface. The output record is compatible with common practice software formats; on request our technician handles the setup.
Which practice software is compatible with SteriTrace?
The export takes place via network folder or FTP in a format that common practice and documentation software understands. Simply let us know which program you use and we will check the connection for you.
Does SteriTrace fit into my existing IT environment?
Yes. The export to your practice software runs via network folder or FTP, completely offline without a cloud if you prefer. This lets SteriTrace fit flexibly into almost any IT environment.
Does SteriTrace also work without an internet connection?
Yes, SteriTrace can be operated entirely offline if you prefer. The documentation and the export to your software then run locally within your network.
Does the autoclave create the sterilisation records itself?
Yes, every Steri24 autoclave generates and stores the sterilisation records with date, program and process data automatically. These can be saved to USB/memory card, transferred via LAN/WLAN or printed out.
How do I save the sterilisation records to a USB stick?
The records can be exported as txt files to a USB stick; the USB port is located on the door or at the bottom right of the device. It is best to use a stick that is as empty as possible with a maximum of 16 GB in FAT formatting.
How is batch release documented and what must it contain?
Batch release must be documented according to RKI – either handwritten or digitally with SteriTrace. It records the determined process parameters, the release decision as well as the reference to the batch and the releasing person.
What does the KRINKO/RKI recommendation require for batch documentation?
According to KRINKO, the recorded measured values of the process parameters and the release decision must be documented with reference to the releasing person and the batch. You must demonstrate that the process ran in accordance with the standard operating procedure and validation report.
Who is allowed to grant batch release?
The persons authorised to grant release must, according to KRINKO, be designated in writing for quality management reasons. SteriTrace assigns each release to the releasing person and makes it traceable in an audit-proof manner.
When does the reprocessing of a medical device formally end?
According to KRINKO, reprocessing ends with the documented release for use. This is based on the agreement of the determined process parameters with the validation reports as well as on the inspection of packaging and labelling.
How long must sterilisation, release and reprocessing records be retained?
According to KRINKO/RKI, the records must be kept for at least 5 years; depending on further legal bases, longer periods may apply. Many practices therefore archive long-term as a precaution, ideally digitally.
May documentation be changed afterwards?
No. According to KRINKO, the original content of an entry must not be made illegible, and changes must remain recognisable. A digital solution like SteriTrace automatically ensures this traceability.
May the records also be kept digitally instead of on paper?
Yes. According to KRINKO, the records may also be kept on image or data carriers, as long as they remain available and legible during the retention period. SteriTrace meets exactly this requirement.
What is the advantage of paperless documentation compared to paper records?
Paperless documentation saves hours every week, avoids fading thermal paper and makes the authority inspection stress-free. All batches are immediately findable and stored audit-proof.
Where can I find free templates for documentation and batch release?
Steri24 provides free templates, e.g. a handwritten batch release form as well as a detailed knowledge document in the wiki. Alternatively you document digitally with SteriTrace.
Can I also document batch release by hand?
Yes, handwritten batch release is permitted, e.g. using the batch release template and a sterilisation pen. Labels or barcodes are not mandatory; digitally, however, it is considerably faster and more secure.
How is the batch number assigned?
The batch number is a consecutive figure that increases by 1 with each program run of the autoclave, thermal disinfector or sealing device. When sealing, it counts per pouch.
When must the batch number be written on the packaging – before or after sterilisation?
Always after sterilisation. At minimum the batch number is written on the packaged instruments, ideally with a sterilisation pen without toxic chemicals; tracing labels are also only applied afterwards.
Do indicator and test strips have to be retained long-term?
Batch and sterilisation strips as well as washer-disinfector indicators no longer have to be retained long-term. However, the batch release itself must still be documented.
How do I tell from the record that sterilisation was successful?
The record shows the achieved process parameters such as temperature, pressure and holding time and confirms them with a success or fault status. If the values match the validation report, the batch is eligible for release.
What distinguishes the Premium autoclaves from the Pro models in terms of documentation?
The Premium models offer WLAN/LAN connection to the practice software as well as paperless batch release and documentation directly on the touchscreen with SteriTrace. With the Pro, documentation is done via integrated printer/USB.
Do I still need the paper printer if I document digitally?
No. On many devices the paper printer is disabled at the factory; the records are stored automatically regardless and can be exported via LAN, WLAN or USB. You can switch the printer on or off in the menu.
Does the Helix test have to be documented additionally?
Yes, the documentation of the Helix test is required according to RKI or the recommendation of the chamber, independently of a personnel code lock on the autoclave. An additional handwritten end-of-day record is, however, no longer necessary when using PC software with password release.
Is the filter change documented?
On Premium models with a touchscreen you confirm the change of the bacterial filter on the display using the enclosed code for complete documentation according to RKI. The filter is replaced approximately every 150 cycles.
What documentation is required for the sterilisation of critical instruments?
In addition to the sterilisation record, you need documentation in accordance with RKI with labelling and traceability. For sets and trays, illustrated tray lists with a sample loading are additionally useful to demonstrate batch release.
Does the batch number also have to be documented for the thermal disinfector?
Yes, the batch number is also important for the thermal disinfector; the batches must be traceable just as with the autoclave. SteriTrace can consolidate the records from the autoclave, washer-disinfector and sealing device.
What documentation obligations apply to the sealing device?
The requirements may vary depending on the responsible chamber, for example a daily seal check and an annual validation of the sealing process. A seal seam test is required if you seal critical medical devices for use on humans.
Do disinfection trays have to be labelled and recorded?
Yes, depending on the application, disinfection trays are subject to documentation and labelling obligations under MPBetreibV. The change of the baths is recorded with date and the person carrying it out; digital documentation supplements the labelling.
Is electronic documentation legally equivalent to paper documentation?
Yes, according to KRINKO the records may be kept on data carriers as long as they remain available, legible and traceable. SteriTrace meets these requirements and is therefore equivalent to the paper form.
What must a standard operating procedure for release contain?
According to KRINKO, the standard operating procedure must define the form of documentation of the release decision and the procedure in the event of deviations from the correct process. We are happy to advise you on setting up these procedures.
Does SteriTrace help with the authority inspection?
Yes. Because all batches are stored completely, audit-proof and immediately findable, the required evidence can be presented quickly during an inspection. This makes the inspection considerably more relaxed.
Can I export records afterwards and pass them on to authorities?
Yes, the stored records can be exported at any time via LAN, WLAN or USB and presented to the responsible authorities on request. According to KRINKO, the evidence must be kept on hand anyway.
Do I also receive documentation with validation and maintenance?
Yes, as part of validation and maintenance you receive the associated documentation, e.g. the validation report. For the ongoing documentation of reprocessing we are happy to advise you on the suitable SteriTrace solution.
Do you also offer the ongoing documentation of instrument reprocessing?
Yes, in addition to the documentation from validation and maintenance, Steri24 offers a solution for ongoing, paperless documentation of reprocessing with SteriTrace. Contact us for individual advice.
How much time do I save with paperless documentation?
With paperless batch documentation, practices typically save several hours every week, because labelling, sticking in and filing paper records is no longer necessary. Release is achieved in a few clicks.
Where is the data from SteriTrace stored – cloud or local?
Storage takes place entirely locally via network folder or FTP if you prefer, without a cloud. This way you retain full control over your documentation data.
Can SteriTrace consolidate the records of several devices?
Yes, SteriTrace is designed to document the batches from the autoclave, thermal disinfector and sealing device together and to bundle the release in one place. This keeps the entire reprocessing process traceable.
What happens to the documentation if a cycle fails?
A faulty or aborted cycle is shown in the record as unsuccessful and must not be released. The procedure for such deviations should be defined in your standard operating procedure; SteriTrace documents the process traceably.
Do I need a label or a barcode for digital documentation?
Labels or barcodes are not strictly required; handwritten labelling is also permitted. For critical instruments, however, there is a batch tracing and labelling obligation, which SteriTrace conveniently supports.
Does the Steri24 documentation meet the RKI requirements?
Yes, the Steri24 Class B autoclaves and the SteriTrace documentation are designed for the RKI/KRINKO and MPBetreibV requirements. All documents and certificates are available as a download with the product in the shop.
How does SteriTrace differ from solutions of established expensive manufacturers?
SteriTrace offers paperless, RKI-compliant batch documentation with a connection to common practice software – at a fair price and with a large on-site service network in Germany, Austria and Switzerland. Other providers often tie you to closed, more expensive systems.
Is the connection to my software associated with additional costs?
On request, our technician handles the setup of the connection; we agree on the exact scope individually with you. Let us know your software and availability and we will prepare a suitable offer for you.
Can I continue to use existing templates and switch to digital step by step?
Yes. You can continue to use the free handwritten templates and switch to digital documentation with SteriTrace at any time. Parallel operation during the changeover is easily possible.
Which devices support digital batch release on the touchscreen?
Above all the Premium autoclaves with a touchscreen support digital batch release and documentation directly on the device via SteriTrace. You can quickly find out which model suits your workflow using the autoclave configurator.
Does the documentation help with traceability in the event of a claim?
Yes, complete batch documentation enables the traceability of each batch back to the release decision and releasing person. In the event of a claim or complaint this is important evidence and is required under KRINKO.
How do I find out which autoclave with suitable documentation is right for me?
The easiest way is to use the autoclave configurator or a short consultation. We recommend a model and documentation solution to suit the number of practitioners, the volume of instruments and your practice software.
Does Steri24 offer training on documentation and operation?
Yes, an introduction is included on site during commissioning or initial validation; on request we also train your staff in sterilisation and documentation. This way everyone involved works safely with SteriTrace from the start.