samedan logo

home > news > detailed info

New Report Uncovers the Extent of Data Integrity Challenges for UK Pharmaceutical Manufacturers


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.

As well as exploring historic and emerging challenges, Managing Data Integrity in Pharmaceutical Manufacturing details the principles of good data management in the sector and an overview of the shifting regulatory landscape that manufacturers now have to contend with.

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.”

To download a copy of Managing Data Integrity in Pharmaceutical Manufacturing, please visit:
email 9-32, Nakacho 2-chome, Musashino-shi, Tokyo 180-8750
Print this page
Send to a friend
News and Press Releases

Study to Understand Fatal Genetic Diseases in Children Becomes First to Incorporate a Digital Participant Education Programme

More info >>

White Papers

Convergence in the Pharmaceutical Market

PCI Pharma Services

Convergence is currently playing a large part in the growth of the pharmaceutical market. The need for convergence is due to many factors including the declining economy and high competition within the sector. There are many convergences within this sector to date; these include the convergence of food based products with medical and health products and the convergence of prescription drugs to over the counter (OTC) products. Although convergence is helping the pharmaceutical industry expand and develop, it also poses some challenges; these include the regulatory outlook and counterfeiting.
More info >>

Industry Events

Connect in Pharma

14-15 September 2022, Plaexpo, Geneva, Switzerland

The new event driving innovation for pharma and biopharma businesses, Connect in Pharma will unite key players in Pharmaceutical and Biopharmaceutical packaging and production in Geneva on 14 – 15 September 2022.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement