Adeodata, as gold sponsor of this event, took part with a booth and above all with the interesting speech of Ing. Pier Luigi Agazzi, who opened the event with the delicate issue of Data Integrity.
The electronic records management, from validation to data integrity, is a really hot topic and both FDA and EMA are really insisting on it, during the current inspections too.
Starting from ALCOA requirements (Attributable – Legible - Contemporaneous, Complete and Consistent - Original - Accurate), Mr. Agazzi compared paper and electronic data and reported some cases of data falsification and some problems of integrity.
Mr. Agazzi made a quick reference to the Governance of Data Integrity as well, that is the set of measures adopted in order to guarantee that data, indipendently from the format of generation, are properly recorded, elaborated, stored and used to assure its integrity (or rather its completeness, consistency and accuracy) for its whole life cycle.
The speech ended with the rising topic of the Internet of Things (IoT), with evidence of interesting consequences on data efficiency and integrity and of a synthetic cost-benefit analysys related to its application in labs.
All the attendees partecipated with clear interest and with several questions about the management of user/admin profiles and about the audit trail, until the coffee break.
Waiting for the next QC Pharma Day, planned for 2018, October 4th.
