The ValidR software manages a combination of various disciplines and activities. Built on our IAVS-M2 measurement equipment, ValidR guides you simply through the entire validation process:
- Management of validation and reporting protocols
- Design of a validation plan, the basis for the measurements and the final report
- Direction and guidance in performing the measurements
- Automatic generation of partial and final reports.
With ValidR you design and manage structured protocols to define the necessary process settings and operating instructions in relation with:
- the specific process parameters of each process/load combination;
- the applicable standard for the validation and its assessment criteria;
- automatic calibration of thermocouples before and after the validation measurements;
- performing the actual measurement of the processes including instructions for loading, positioning of thermocouples and all relevant comments
- and other settings, eg. for the graphical display in the report.
Figure: Validation protocol with thermocouple arrangements.
This support clearly contributes to a good reproducibility especially since independence in the operations is requested. Because of this, also the results of successive validations become comparable, which creates an overview of the process in time.
In addition to these measurement and calibration protocols ValidR also has reporting protocols. Initially these relate to the standards, requiring reports on the identification of the machine to be validate and on eventual primary technical defects. In addition however, free text protocols can be added, which allows the user to insert other sections into the final report.
The following European standards and Dutch guidelines are available in ValidR:
- EN554: Validation and routine control of sterilization by moist heat
- EN285: Sterilzation - steam sterilizers - Large sterilizers
- EN13060: Small steam sterilizers
- EN17665: Sterilization of health care products - Moist heat
- D6101 : Vacuümlektest (Vacuum Leakage test)
- D6103b: Validatie van stoomsterilisatieprocessen voor medische hulpmiddelen
(Validation of steam sterilization processes for health care products)
- R6103: Validatie van stoomsterilisatieprocessen voor medische hulpmiddelen
(Validation of steam sterilization processes for health care products)
- R6105 : Controle op primaire technische gebreken bij stoomsterilisatoren voor medische hulpmiddelen in ziekenhuizen
(Checking primary technical failures in steam sterilizers for health care products in hospitals)
- R6106 : Controle op primaire technische gebreken bij stoomsterilisatoren voor medische hulpmiddelen
(Checking primary technical failures in steam sterilizers for health care products)
- R6107 : Validatie van stoom/watersterilisatieprocessen voor waterige vloeistoffen in gesloten containers
(Validation of steam/hot water sterilization processes for liquids in closed containers)
- R6108 : Validatie van stoomdestructie (Validation of steam destruction)
- R6111 : Validatie van heteluchtsterilisatieprocessen (Validation of hot air sterilization processes)
- R6112 : Controle op primaire technische gebreken bij heteluchtsterilisatieprocessen
(Checking primar technical failures in hot air sterilization processes)
- R6151 Validatie van thermische desinfectieprocessen voor medische hulpmiddelen
(Validation of thermal disinfection processes for health care products)
- EN15883: Washer-Disinfectors: Requirements and tests
Relevant new standards are added and existing standards adapted to the latest state of affairs regarding the development of these standards.
Furthermore, customer-specific standards can be provided on request if special (different) processes must be validated.
The validation plan
With the predefined protocols as a basis, you set up a validation plan with ValidR, in which all the steps required for the implementation of the validation are arranged. The plan with all the measurement protocols for the processes to be measured and supplemented with reporting protocols thus forms a clear guideline for the measurement session and also serves as the basis for the final report.
Figure: ValidR measurement session consisting of 15 protocols/paragraphs.
The validation plan is stored in a clear file structure and it can also be repeated at the next re-validation. Responsibilities for setting up the plan (and the underlying protocols) and the execution of the measurement session are separated by means of applicable user privileges.
During the measurement
During the validation the validation plan shows which measurements should be performed. After following the instructions for proper loading and placing of thermocouples, the process is started and the measurement results are displayed on screen in real time, numerical and graphical presentations with selection and zoom capabilities. The applicable standard criteria are online checked and verified and eventual special findings such as deviations are reported directly. This creates a direct insight into the process performance during validation . Also during other types of process examination or maintenance, this information is particularly useful for the analysis of the process performance.
ValidR is multi-tasking and it can therefore perform another scheduled reporting protocol, while a measurement runs in the background. This efficiently uses the waiting period, which typically exists during the measurement cycle.
Afterwards the measurement results are stored with the validation scheme in a single data file (if required, the entire data set can be copied and further processed elsewhere). The validation engineer adds other metrics, such as readings from designating instruments, and notes to record his personal findings and comments.
The measurement results are retrievable in tabular or graphical form, so any detail can be analyzed and discussed immediately.
Graph: Steam sterilisation process.
At the end of each measurement the results can be further analyzed for anomalies, and/or settings and criteria may be otherwise applied.
Figure: Analysis of registrated measurement data.
In addition to the overall assessment of the process flow in the graph, it is possible to change certain settings of the measurement protocol afterwards. If the registration fails, eg. due to a faulty thermocouple, it can be suppressed in the results; or yet a graph definition is changed to improve a certain part of the picture. Also certain test criteria may be applied differently, if permitted by the standards definition.
ValidR can summarize the actual measured values and test results in different (sub) reports:
- a short report with a brief summary of the measurement;
- a comprehensive technical report with readings, charts and test results per measurement;
- separate graphs with temperature and pressure curves, enlargements, hot/cold curves and legends;
- and a composite final validation report.
All reports are available in MS-Word format and they may be possibly further processed and stored from there, while of course maintaining the validated measurement results. And thanks to the existing reporting protocols, all textual report parts are already filled out during the validation, so that in the end the complete final report can be generated with a single mouse click. This will save you writing reports afterwards and you can also directly present your substantiated findings to the appropriate expert/customer. Also a preliminary process release, subject to the completion of the final report is then no longer necessary.
You can download a demo final report (in. Pdf format) here. This report was generated entirely on the basis of the protocols and measurement results of the measurement session shown above.