The development of new technology is playing a pivotal role in the advancement of both patient autonomy and drug development. It’s a huge challenge for regulators to ensure drugs being manufactured are adhering to uniform standards of quality and safety. Graham Francis, Product Marketing Manager at Kallik, explains how data integrity should be a top priority when using new technologies in the pharmaceutical industry.

More drugs are being developed and manufactured in laboratories than ever before. This not only increases scrutiny of drug submissions and releasing data for compliance, but drugs need to be created as safely and securely possible.

Quite rightly so, manufacturers need to be providing regulators with full, comprehensive accounts of high-quality data. This data should be securely checked in thorough procedures and administrative controls which should be an integral part of manufacturers’ processes.

This doesn’t however, stop regulators from finding cases of data mishandling, or even ‘cherry-picking’. Advancements in technology has increased pressures on data analysts to consistently be fully and efficiently compliant, which has in turn created ‘orphan data’ — data that is never reviewed or assessed in official records sent to regulators.

In some cases, company expectations outweigh ethical considerations, which has caused a breakdown in the trust of regulators and put public safety at risk. Analysts under pressure could be prone to cutting corners and delivering unsafe and immoral results, allowing this behaviour to become standard practice of quality control.

With regulators conducting more in-depth reviews of laboratory results, tools are becoming more sophisticated to create an inclusive and complete audit trail. Tracking the existence of all data, including so called ‘orphan data’, is becoming a more regular, modern-day approach, as well as making full lists of data available, which is the result of new technology development.

Data management compliance tools are being built to support electronic records, allowing manufacturers to have complete transparency and traceability when presenting their pharmaceutical data.

It’s remarkable to think that some laboratories today are still relying on written notes, paper printout records or the like. Working in this dated process will not only lead to traceability gaps but will miss vital data-checking procedures and not give a complete overview of the data that has been captured.

Manufacturers working more efficiently will only look to rebuild regulatory trust and keep public safety as a top priority. Modern-day automated tools allow manufacturers to remove any kind of doubt and interference with data, leaving them with absolute clarity and confidence when disclosing data to regulators.

Originally posted by EPM magazine on 6th June 2018.

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