PDA Letter Article

Data Integrity Validated as Key Issue

by Bruce Loxley, GSK Vaccines, PDA Singapore Chapter Member-at-Large

Feat 2

Aug. 28 marked the most successful and well-attended event in the PDA Singapore Chapter’s five-year history. The topic? Data integrity and computer systems validation.

Almost 60 pharmaceutical industry representatives attended the event which served as a follow-up to a data integrity roundtable hosted by the chapter in 2017.

After lunch, Chapter President Dinesh Khokal kicked off the event by highlighting how regulators’ focus on data integrity has ramped up exponentially in the last ten years event though the topic is often regarded as “nothing new.” Following his remarks, Isara Isarowong presented how assuring good computer systems validation ultimately ensures data integrity requirements are met. He made the point that the quality of computer systems validation protocol writing and execution is often variable, and that some data integrity risks could be easily missed during initial qualification.

Mehul Patel then focused on the human element in microbiological QC testing and methods, and how to reduce that by shifting as far as possible to more quantitative methods rather than relying on well-established but antiquated qualitative methods. Related to this, Harry Benson covered workplace quality culture and how a firm’s leadership can encourage correct behaviors in a safe environment.

Data integrity is a very serious topic, so after the coffee break, Bruce Loxley livened things up through an audience quiz, checking symposium participants knowledge of data integrity risks. Even some of the speakers had trouble! This shows that these types of meetings are essential to ensuring data integrity across the industry.

Thomas Halfmann then gave a very informative talk on what auditors are looking for in the in the context of data integrity and how to conduct data integrity maturity risk assessments.

For a positive note, Kok Chia Phei gave examples of some real-life data integrity issues, how they were discovered, how root cause was established, and how they were resolved. For the many participants working in data integrity remediation, this proved to be the highlight of the event. To close this successful event, Sudhir Goudar, helmed an interactive panel discussion.

The Singapore Chapter thanks all the speakers and those involved in making this a successful event.

PDA Who's Who

  • Harry Benson, Global Director, Human Performance Services, Commissioning Agents
  • Sudhir Goudar, Head, Compliance, Asia, Novartis
  • Thomas Halfmann, Founder and Managing Partner, HGP
  • Isara Isarowong, Novartis
  • Dinesh Khokal, PhD, Director, External Affairs, JAPAC and LatAm, Amgen
  • Bruce Loxley, Senior Manager, Audit I&TPO, GSK Vaccines
  • Mehul Patel, Global Marketing Director, Charles River Laboratories
  • Kok Chia Phei, Senior Computer Systems Validation Consultant, Visentic Solutions