Renewed attention of the authorities inspectors to the Data Integrity
The QC laboratories work in a highly regulated environment where effective electronic data management processes ensuring Integrity are a must. Therefore, these processes are still largely based on paper, preventing efficiency improvements that could be really useful.
The renewed attention of the authorities inspectors to the Data Integrity is pushing towards the management of instruments GMP data output in their original electronic format, preserving their contextualization (meta-data), any exceptions, quality control records and, in some cases, the Dynamic format that allows the data processing, including the re-evaluation of results or the execution of queries.
But the retention of data in electronic format has some pitfall. As an example, most of the software that manage analytical instruments do not provide any mechanism to record the data review by means of an electronic signature. While the GMPs require to document the data review.
The review in electronic format is available only on the most advanced platforms for Chromatographic Data Management System, for HPLC or GC. Simple instruments (ph-meters, scales, legacy instruments, etc) and also UV or IT spectrometers, titrators, densimeters, etc. do not support the electronic review, therefore the results are often printed in order to collect the signatures for the review.
With Ioi it’s possible to carry out the electronic review using electronic signatures and increasing the lab efficiency.
Electronic Review by Ioi – Integration of instruments
This feature, improved in the version 2.0 of the system, is designed to automate a business process This involves capturing what has been acquired by the field (measurement, notes, signature, contextualization, etc.) so that a reviewer can retrieve the electronic data to analyse and review for the final approval, through electronic signature, in a fully paperless process.
The new release of Ioi – Integration of instruments offers a fully paperless Electronic Review feature for almost all the data acquired, generated and processed. Based on the fact that this amount of collected data needs to follow a specific review flow, Ioi supports the Electronic Review feature to accomplish the whole life-cycle of every measurement and each meta-data related to it.
This functionality allows to carry out:
- Electronic Review configuration
- Measurements Review based on a configured contextualization
- Ioi Audit Trail Review
- Instrument Logbook Review
Measurements Review can be configured to meet the customer procedure. In this way, review permissions need to be associated to the reviewer role to let him/her access to such a process.
Ioi supports electronic signatures, which are required by the system for some specific actions, such as confirmation or rejection of a measurement or a performed review.
Ioi can be used in two different scenarios.
- A “less-paper” scenario, where at the end of the measurement and review process, Ioi is used to generate any required report (including the review), such as:
- Measures Review notes and signature
- Sample\Analysis sheet master container approval cycle
- Instrument Logbook review details
- Audit Trail review details
- A paperless scenario, where Ioi can transfer the results to an upper level system (LIMS, ELN, etc.). In this scenario it could be possible to interface the instruments directly to the LIMS or ELN, but each instrument would require a specific interface. Instead, Ioi can be quickly interfaced to the whole instrumentation and to the LIMS/ELN with a single interface.
In both cases, the original data are retained on Ioi.
Ioi – Integration of instruments goals… we haven’t forgotten the Data Integrity
Along with the electronic data management, the integrity of data is also crucial. Ioi – Integration of instruments, designed on the concepts of security, reliability and robustness of data. It represents the ideal starting point to achieve concrete Data Integrity-compliant results in the lab.
In conclusion, Ioi achieve these main goals:
- guarantee the Data Integrity compliance
- increase the process reliability reducing manual transcriptions
- improve lab efficiency optimizing the business processes (up to 50% of time saving)
- improve performances according to the regulations requirements
- enables a paperless, or at least a less-paper, lab
The Ioi application is fully validatable versus the requirements of FDA 21 CFR-11 and Annex 11 to European GMP (including Data integrity).
Quick installation of Ioi – Integration of instruments
Moreover, it’s quick installation (weeks) and simple management make it easy to realize typical lab processes without the complexity of projects such as ERP, LIMS or ELN. At the same time, Ioi does not replace these systems, but rather it gives its best when it’s placed between laboratory instruments and a LIMS (Laboratory Information Management System).
In case of a future ELN or LIMS implementation, the presence of a single interface thanks to Ioi, instead of an interface for each instrument, allows to preserve the investments.
Ioi is vendor-independent (all brands of instruments are interfaced) and is a web-based system.
Emmanuele Dicerto, Chief Technology Officer at Inpharmatic
Inpharmatic is a team combining professionals with more than 25 years of experience in the pharmaceutical industry and a new generation of software designers, coordinated by project managers of international experience. The team aims to add the benefits of efficiency and integration to the systems compliance with the requirements of Data Integrity. In this way, investments in Data Integrity become a competitive advantage for the pharmaceutical industries. Inpharmatic is enlarging and structuring its organization in order to support the success of the proposed solution.
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