A manufacturer of pharmaceuticals in the Asia-Pacific region engaged SeerPharma to deliver an onsite training workshop on Data Integrity to staff involved in Production, Quality and Warehousing.
The training was tailored to the client’s infrastructure and operations and with a focus on the
following topics:
- What does data integrity (DI) mean, who can contribute to good DI?
- Why is data integrity and security such a hot topic for regulators?
- Data criticality and data risk
- Integration of DI into your QMS using a risk-based approach
- What constitutes raw data?
- Protection and security of raw data and original records
- Control of your data when utilising vendor third parties
- Developing practical audit and remediation strategies for DI
Contact us if you’d like to learn more about how we might be able to assist with any issues you believe you might have with the management of data, records and signatures across your operations.
This post comes from our July 2018 Journal. You may also be interested in:
