Quality and Safety

Quality

The importance of high-quality software when analyzing patient data

The analysis of clinical and research samples should only be performed while maintaining high quality standards, to ensure correct and reproducible results. During more than 10 years of experience in the industry, Cytognos has established extensive quality procedures for the development of Infinicyt™.

Testing and validation occurs at many stages in the development process. The impact of any modification on the quality of existing functionality is always tested with manual and automatic procedures. Before any release, Infinicyt™ undergoes in-house verification and external validation from the EuroFlow™ group. Over 1000 individual automatic tests are performed, and results from manual and automatic tests are documented. Statistical results are particularly reviewed in many different ways in order to ensure that changes have not impacted the calculations.

We have included an automatic report of critical bugs that is sent to us if such errors occur. Every bug report is evaluated to determine its impact on clinical results. Every time a new version is released, we will inform each customer if any error improvement they have requested is included in the version. Besides, we publish any workaround that can help you work with existing bugs to avoid the potential impact on patient care.

Cytognos performs periodic scheduled reviews of all quality procedures and documentation. Changes to procedures that have occurred since the latest review period are re-evaluated considering the quality implications. An independent auditor inspects all documentation and procedures periodically to ensure their completeness and quality.

For those who need it, we can provide IQ/OQ certificates containing evidence that Infinicyt™ works within the specifications of your flow cytometry data environment.

Please contact us if you have some requirement on this matter

Safety

Security is critical when handling patient data

Infinicyt™ 2.0 enable User Access Control and Authentication of unique users, with specific username and password combinations and several roles available. The administrator can establish different levels of software access per role and various security policy settings per user (e.g. password aging, inactivity log-off). Learn how these features can help you comply with 21 CFR part 11.

Password-protected analysed files ensure electronic records security and help to prevent unauthorized manipulation of the data. Files are also encrypted for increased security during data transmission over a network.

Audit trails allow to track every analysis and reporting action performed within the file. This time-stamped, user-specific list of actions facilitates analysis traceability of every single file. Electronic signatures can be used to certify the analysis and to sign reports with three different status: Analysed, Approved and Issued.

All Infinicyt files can be anonymized and encrypted so that you can share them with a second-opinion laboratory while safeguarding patient privacy.

Do not lose relevant information. Even if there is a computer or software crash, the auto-recover tool will allow you to recover your files at the point where the crash happened.

Check out our last webinar

In this workshop, our colleague Irene González Barahona (Key Account Manager from East Coast – US and Canada) presents Infinicyt™ security features to ensure traceability and security of your patient data such as User Access Control, Password-protected Files, Audit Trails and Electronic Signatures.

This workshop was first displayed at ICCS 2020. Watch this video to learn how Infinicyt software can help you meeting regulatory compliance and standards requirements of your clinical laboratory (FDA 21 CFR Part 11 regulation & ISO 15189:2003).