The new year is the perfect time to take stock and set goals for the year ahead. Have you defined your compliance plan for 2020? Without a crystal ball to provide “20/20” vision into the next 12 months, making new year resolutions can help align and focus your efforts and energy in your quest for success. Take tips from IQVIA’s Quality Compliance subject matter experts and consider adopting some of these 20 resolutions to help you fuel your organization’s success in the new decade ahead.
As a Quality professional, I resolve to:
- Focus on Quality first, knowing Compliance will follow. – Kari Miller, Regulatory & Product Management Leader, IQVIA Quality Compliance
- Think beyond traditional quality management, and start envisioning quality as an integrated, participatory business process in the organization’s overall eco-system – one that embraces technology, enables quick qualitative and quantitative decision-making, and contributes to the overall bottom line, while improving quality of life and safety for the patient. Then, invest to make it happen. – Bill Buzzeo, Vice President and General Manager, Compliance Solutions, IQVIA
- Fully and honestly understand the organization’s Quality Maturity, the true total Cost of Quality (COQ), and the savings tied to maturity improvements from implementing integrated enterprise quality, compliance and risk management solutions. – Larry Ferrere, Sr. Director, Strategy & Marketing, IQVIA MedTech
- Borrow a page from ISO13485:2016 and take a risk-based approach to managing organizational quality and compliance with industry regulations. – Donna Smith, Product Manager, IQVIA Quality Compliance
- Follow closely new EU MDR regulations and guidance documents which are relevant to our products and processes, and, as a company, commit the necessary resources for timely implementation. – Caroline Freeman, Sr. Consultant, IQVIA Quality Compliance
- Avoid last-minute panic by engaging early with expert consulting services to make sure operations are aligned with the upcoming EU MDR 2020 requirements. – Larry Ferrere, Sr. Director, Strategy & Marketing, IQVIA MedTech
- Be thoughtful in the use of social media and e-mail exchanges with colleagues, clients and vendors. We work in regulated industries and need to be always aware that abrupt language or tone can be misinterpreted. Embrace technology, but with care and respect! – Phil Johnson, Sr. Principal, IQVIA Quality Compliance
- Contribute to pushing the borders of Quality out beyond its immediate departmental walls to encompass all components of the operation’s ecosystem. – Florian Czaszewicz, Sr. Sales Engineer, IQVIA Quality Compliance
- Ensure the organization readily embraces a culture of change, flexibility, and adaptability to better enable it to adapt to evolving internal and external regulatory requirements. – Davor Milosevic, Quality Assurance Manager, IQVIA Quality Compliance
- Increase the organization’s operational efficiency by establishing internal training that details processes, products and services so that as new employees come aboard, they can quickly be brought up to speed. – Rebecca Melvin, Engagement Manager, IQVIA Quality Compliance
- Take a partnership approach with a QMS provider to stay ahead of 2020 Quality Compliance industry regulations to make agency enforcement actions and warning letters a thing of the past! – Kyle Brant, Sr. Account Executive, IQVIA Quality Compliance
- Embrace necessary changes impacting the industry at all levels and integrate them across the organization to bring higher quality and safer products to the market. – Florian Czaszewicz, Sr. Sales Engineer, IQVIA Quality Compliance
- Drive continuous improvement through the supply chain. – Joshua Centner, Associate Director, Sales Engineering, IQVIA Quality Compliance
- Strive to improve and lower compliance costs by implementing multi-site asset management software to support consistency in workflows and processes across facilities and applications. – Jim Erickson, President, Blue Mountain Quality Resources
- Comply with medical device product lifecycle regulations regarding design control and reduce the risk of audit findings by placing all design evidence and documentation within a single source of truth – an automated design control solution. – Todd Neal, Product Manager, IQVIA Quality Compliance
- Manage and mitigate risks efficiently throughout the value chain, and make sure processes, systems, and resources are aligned. – Florian Czaszewicz, Sr. Sales Engineer, IQVIA Quality Compliance
- Identify new and additional solutions to addressing quality and regulatory compliance concerns such as integrated global compliance offerings, including a Quality Management System (QMS), Regulatory Intelligence Database (RID) and Regulatory Information Management System (RIMS). – Larry Ferrere, Sr. Director, Strategy & Marketing, IQVIA MedTech
- Be flexible in working with new technology partners to convey our requirements in a manner that makes meeting our objectives more achievable. – Ian Elius, Associate Client Relationship Director, Cloud and Customer Success, IQVIA Quality Compliance
- Increase utilization and efficiency of quality processes through process harmonization within an electronic Quality Management System (QMS). – Josh Centner, Associate Director, Sales Engineering, IQVIA Quality Compliance
- Use a Quality Management solution platform as an enabler to support objectives, improve performance and achieve business success. – Florian Czaszewicz, Sr. Sales Engineer, IQVIA Quality Compliance
In keeping with tradition over the years, IQVIA subject matter experts and their technology partners have provided a multitude of thoughtful new year resolutions that you might also consider. View the 2019 and 2018 blogs for even more ideas of how you can vow to support your organization in its pursuit of continuous improvement.
Share these resolutions with your colleagues as you strive for a successful 2020. A commitment to Quality Compliance is a resolution worth keeping.
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