There are IT approaches that can be implemented to reduce data conduct risks significantly


A question of I

n April 2016 the FDA issued for comment a new draſt guidance for the pharmaceutical industry to help clarify ‘the role of data integrity in current good

manufacturing practice (cGMP) for drugs’. Te guidance has been draſted because, as the US drug regulator states, over recent years its inspections have uncovered increasing numbers of cGMP violations in which data integrity is involved. Put politely, the FDA is witnessing more

cases of the pharmaceutical industry being less careful than it should be, when it comes to putting in place measures to secure and ensure the integrity of its data. It’s a serious issue, because decisions based on the wrong data can ultimately allow the release of medicines that aren’t safe. Drugs approved on


Sophia Ktori investigates the use of informatics software to increase data integrity in the laboratory

the back of inaccurate trials data, for example, may even constitute a risk to patients’ lives.

Real-world consequences Coincidentaly, not long aſter the FDA issued its latest draſt guidance on data integrity, a relevant scenario hit the headlines, when the European Medicines Agency announced that it was to start reviewing all nationally approved drugs in Europe for which studies had been carried out by contract research organisation (CRO) Semler Research Centre in Bangalore, India. Te EMEA review will follow up on serious

concerns raised by both FDA and the World Health Organisation about the integrity of Semler’s data and the possibility that samples at the organisation’s bioanalytical and

clinical sites had either been manipulated or substituted. Te FDA and WHO questioned the reliability of Semler-generated data that would have been used to support national drug marketing applications and authorisations in individual EU countries, and the European drug regulator will now have to investigate each new national drug application and approval for which Semler data was included. Data integrity refers to the completeness,

consistency and accuracy of data. It’s a definition that FDA had already referred to more than 20 years ago, explains Daniela Jansen, senior product marketing manager at Dassault Systèmes Biovia. To be met, the definition also requires that the complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA). ‘It’s by no means a new topic, but it is worth revisiting, particularly in light of FDA’s admission that it is seeing increased

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