PM Group Experts on Operational Readiness in Pharma
PM Group CQV and EVal experts, Fintan Coady and Michael Sweeney, recently led a fantastic Kneat webinar on Operational Readiness in Pharma. The discussion explored how digital validation can drive speed, compliance and confidence in GMP manufacturing.
Watch this video to learn more from our experts:
Fintan Coady shared:
“One of the key challenges in industry is around Operational Readiness timing. It’s pushed down the line and not seen as a key project deliverable. If it is embedded in the Commissioning and Qualification phase, we can mitigate the risks of inefficiencies down the line.”
Michael Sweeney added:
“Companies should start with an extensive digital strategy, decide on a proven EVal software, preferably something that is regulatory compliant and bring CQV and CSV earlier on in the project.”
The session covered how Kneat’s platform enables:
- Accelerated tech transfers through parallel execution and pre-approved templates
- Real-time project tracking via API integrations
- Automated change control logs linked to validation protocols
- Streamlined Quality Risk Assessments
- Continuous GMP and audit readiness with centralized documentation
For more on this topic, check out PM Group’s latest article: Operational Readiness in Pharma
