Big data, audit trails, system integration and access privileges are among the most pressing data integrity challenges for pharmaceutical manufacturers, according to a new industry report published by Yokogawa.
With many manufacturers already facing historical data integrity challenges, including hybrid systems and ageing equipment, the advent of digital transformation is set to place further pressure on manufacturers looking to remain on the right side of auditors.
Peter Cusworth, Industry Development Manager – Control Instruments Business Division, at Yokogawa UK, comments: “Data integrity is easy to define but notoriously difficult to manage. It’s essentially an ongoing maintenance process that assures the accuracy and consistency of data throughout its entire lifecycle. While simple in principle, it continually questions the validity of a facility’s practices throughout every stage of production.
“There are countless decisions made each day in drug manufacturing facilities, all of which can directly impact human health. Data integrity procedures are ultimately there to ensure a company is producing a consistent, high-quality product. They are also in place to hold repeat violations to account, irrespective of whether they are intentional or not.”
Yokogawa’s report comes at an opportune time, with data showing FDA warning letters for data integrity failings on the rise. The organisation sent 194 warning letters to businesses between 2008 and 2018, with the majority being issued in the latter part of that period. There are several reasons why violations are on the rise – some are simply down to carelessness while others hint at more serious challenges that have emerged in recent years.
Peter concludes: “Ultimately, those with accurate data have the means to demonstrate good practice and can quickly identify where oversights have been made, should they be flagged. Beyond this, data integrity maintains the pharmaceutical industry’s reputation and those working in it while also assuring the public that products are reliably safe for consumption. With manufacturers now able to collect, analyse and model more data than ever before, the need for stringent data integrity protocol has never been stronger.”
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