November 18th 2020
Sharp successfully completed the implementation of QualityOne across its global facilities which now provide enhanced document management, training and electronic change control capability.
QualityOne is a full suite QMS which will be implemented in three phases.
Phase two will begin in January 2021, and will provide corrective and preventive action (CAPA) and deviation management. The final stages of QualityOne rollout with Supplier Management will begin in spring of 2021.
The QualityOne project team has been working since early 2020 to provide a standard implementation approach at each facility, along with a FDA 21 CFR Part 11 compliant system.
Barbara Ost, Divisional Vice President for Quality Compliance & Regulatory Affairs at Sharp said:
QualityOne is the latest development by Sharp to further enhance and strengthen compliance and decision-making while ensuring that we offer a harmonized experience for clients across all of Sharp’s facilities.
The implementation of the QMS platform is indicative of Sharp’s broader commitment to quality, an area of continuous focus and investment throughout our history.
We have exceptional quality credentials and a history of strong regulatory compliance. We have also developed programs to certify staff in quality principles and created numerous roles within our organisation dedicated to quality.
In 2020, Sharp made a number of key appointments to quality leadership roles:
- Christine Gehman, Quality Director, Head of Quality for the Bottling Centre of Excellence (COE) at Sharp Allentown.
- Julius Ewungkem, Head of Quality supporting the Biotech COE at Sharp Allentown.
- Reggie Halton, Head of Quality supporting the Speciality COE at Sharp Allentown.
- Matt Solt, Head of Quality, Sharp Macungie.
Ost added “These appointments embed a robust and dedicated quality leadership for each of Sharp’s COEs in Allentown PA and a new site lead at our Macungie location.
“Matt Solt will ensure Sharp’s quality philosophy continues to be deployed and maintained at the facility in Macungie, which we acquired in early 2020.”
QualityOne is powered by Veeva, which delivers a cloud-based solution tailored to the life sciences, with built-in best practices and automated workflows to give better control and visibility and ensure quality and GxP compliance.