Achieving compliance with data integrity requirements
By Fleming.| 08/01/2019
The Fleming team sat down with Ian Ramsay, UK Former GMP Inspector MHRA , Philippe Lenglet, Servier, France Global IT - Chief Quality Officer, Ferenc Lukács, Egis Pharmaceuticals PLC, Hungary Associate Director, Quality Management to discuss:
What's your company approach to new data integrity requirements? How do you tackle data integrity challenges?
Ian Ramsay
Former GMP Inspector MHRA, UK
I work extensively with a range of companies across the industry, advising on data integrity controls and practices. This ranges from proactive consulting to reactive remediation and some auditing. I believe it is critical to remain pragmatic and balanced on this topic – with practical and realistic solutions to complex issues.
Philippe Lenglet
Global IT - Chief Quality Officer
Servier, France
Objective: to define IT contribution to compliance with data integrity requirements
- Identification of business data integrity and/or IT initiatives
- Establishment of a working group (composition to be defined) to identify the main responsibility (business or IT) for each requirement
- For requirements attributable to IT, identify the IT services (in the sense of a catalog of services) that can contribute to the Servier Group's effort to comply with data integrity requirements
- Ensure a satisfactory level of quality and auditability of these services to meet these requirements or define a compliance plan
Deliverable: catalog of IT services typed data integrity / compliance plan/communication
Ferenc Lukács
Associate Director, Quality Management
Egis Pharmaceuticals PLC, Hungary
We have an own regulation on DI. We started and completed GAP analysis for several system in lab and int he plant as well. We are working on the paper based systems now and we try to move from paper base systems to computer system. In my presentation I shall speak a little bit on DI problems as well.