Q&A Ioi – Integration of instruments

Questions & Answers

After the curiosity aroused by Ioi during the workshop "Digitalizzazione dei processi e dei flussi aziendali" ("Digitalization of processes and business flows"), on April 4th in Cavenago di Brianza, here are some questions and answers taken directly from the seminar.


1. How many tools can I connect to the system?

Ioi is a scalable licensing model. You can start "light" with five or six instruments and then integrate others, without having to revalidate the system.


2. What tools can I connect?

Scales, phmeters, density meters, durometers, etc. In practice, any instrument that can be connected to a printer.


However, for more complex systems (tipically connected to a PC) that have receipts or analytical methods, they are not managed, as well as the traces (raw data) of the spectrometers, so the coverage for data integrity is only partial. Nevertheless, the acquisition of measurements, in order to be able to import them into a LIMS or in other systems automatically, contributes to reduce the transcription mistakes and improves efficiency.


3. Is it possible to activate a signature attesting the revision of the data?

Yes, our product is evolving to follow customer requests. There’s a possibility of electronic signature to attest that the data of the measurement have been reviewed. The implementation of this function is already planned, even if it involves some complexity like managing the measurement that are associated with different lots.


4. Does Ioi read BAR codes as well as QR codes?

Ioi reads BAR codes too and in this case it is possible to use a barcode scanner. If you have more information, you need to have more barcodes: such as the batch code and the description code, or a unique bar code that brings together all the information.


5. Do you sell a documentation package for validation?

Yes, we already provide Functional Specification, IQ, OQ, etc. which are in the standard package included in the price. For the validation, it is a Category 4 Software system according to GAMP 5.

The complete validation package is also available as an option, which includes the Validation Plan, the URS, the final Validation Report, etc. which comes with the support of Adeodata.


6. What are the requirements for Ioi's implementation in the laboratory?

As anticipated, to interface an instrument the only requirement is that there is a printer to be replaced by the converter (a small black box) of Ioi. While for the tablet an ethernet connection is required . The device (for example a tablet), which acts as a terminal, communicates with the scale and with the server connected to the SQL database, both wirelessly and with wired ethernet.

The network with the cable is certainly preferable for the connection between the converter and the server, as the connection is more stable, but if the laboratory or the production environment are not equipped with Ethernet wiring, we have tested wireless installations with connections up to 20 tools without problems. For the tablet, the wireless connection is preferable for reasons of mobility and ergonomics. But a normal PC can also be used as an interface. The only requirement is that you have an internet browser and a bar code scanner if it’s possible.

The server can be both physical and virtual. It will then be necessary to carry out the backup, possibly in an automatic way by using a special software on the network.


7. Can I interface new systems or tools too?

Yes, the requirements for interfacing are also valid for new systems. Ioi is appropriate also if you want to connect new instrument to it, that are maybe already compliant with Data Integrity requirements.

An autonomous system requires administration (administrator password and any user passwords), synchronization of date and time, ticket management or interface validation, specific procedures, etc. which could be avoided if you connect the new system to Ioi.


8. Exportability of data?

The data is stored in a SQL Data Base that is easily accessible for reading, so the data can be easily consulted, even to generate customized reports using Reporting Services software, included in the Microsoft Data Base. The DB is also searchable and the data can be exported (e.g. copied, so the original remains safe in the DB).

Furthermore, the system can also make data available through automatic interfaces based on web services. Indeed, it is possible to use it to communicate directly with the instruments, without using Ioi's native interface (the tablet). This is a useful function for any workflow management systems such as ELN, MES, etc.



>> Read the CASE STUDY: Ioi VS paper


>> Read how to get closer to pharma 4.0


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