Sharp, part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has rolled out the first phase of its new Quality Management System (QMS), Veeva QualityOne.
 
QualityOne is a full suite QMS which will be implemented in three phases. Sharp successfully completed the first phase of QualityOne implementation across its global facilities which now provide enhanced document management, training and electronic change control capability.
 
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 an 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,” Ost continued.
 
“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 organization dedicated to quality.”
 
Leadership Changes
 
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 Halto, head of Quality supporting the Speciality COE at Sharp Allentown.
• Matt Solt, head of Quality, Sharp Macungie.