How can CORPEX Informatics maintain data integrity complies?

ALCOA+ is a set of principles that ensures data integrity (DI) in the life sciences sector, and recently has been the core focus of the pharma Regulators. This leads to the regulatory inspectors become more attention and qualified to detect the data integrity issues. DI Violations are trending up and large pharmaceutical companies getting cited for falsifying data in areas. The consequences are sever including sanctions, suspending losing reputation and customers trust and more...

Key to your Success in this area is the move away from paper-based records to?digital transformation. Increasing levels of automation become more important than ever to ensure data integrity through the entire product life cycle. Corpex informatics present a Quality by design Data integrity standard incorporated and validated practice that prevent the traditional paper based data integrity failures.

Attributable: the data generated must always be linked directly with all the identity of the person or system that collected, generated, or updated the data. With Corpex informatics software, those aspects are captured automatically and kept in the time stamped Audit trail.

Legible: data that is complete, truthful, unaltered, free from errors and reflects the actual observation of activity. with Corpex informatics software, data is always in a readable and identifiable format with no spelling mistakes and is still readable and understood years and even decades after it’s recorded.

Contemporaneous: Data is recorded whenever an activity or action takes place. With Corpex informatics, data are time stamped, that can’t be pre-dated or back-dated.

Original: Records should be original rather than copies or transcriptions. With Corpex informatics, Once the raw data is directly entered into system. for example, on a notepad with approved steps to follow about a given activity.

Accurate: All records should reflect the reality of what happened and should be error-free. With Corpex informatics, the system has built-in accuracy checks and verification controls. Measurement equipment should be regularly calibrated as part of this process.

Complete: No data is missing or deleted. with Corpex informatics data All recorded data have an audit trail to show that nothing has been deleted or lost. the audit trails covering any changes made to the data.

Consistent: A sequence of events about an activity should align with the expected series of events. With Corpex informatics software, data is chronological, i.e., has a date and time stamp that is in the expected sequence. Changes made to an original data recording is time stamped.

Enduring: Ensure details available for longer durations. with Corpex informatics software, specific steps are taken to ensure data is enduring, including putting in place robust and tested data backup systems as well as disaster recovery plans and uninterruptable power supplies. Cybersecurity is also considered.

Available: data required to be readily available for review, audits, or inspections for the required life time of the record. data should be indexed and appropriately labelled to facilitate retrieval. With Corpex informatics software, data storage systems are searchable, with data properly indexed and labeled with huge data mining and graphical representation tools.

following the ALCOA+ principles is a high priority in all life sciences sector.

With Corpex informatics, data integrity will be more guaranteed. Product quality, patient safety, and regulatory compliance is ensured.

If you want to know more, please contact us on [email protected] or visit our website: https://www.corpex.info/

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