The new year is the perfect time to take stock and set goals for the year ahead. Have you defined your quality 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:

1. Focus on Quality first, knowing Compliance will follow. – Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA
2. 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, VP, Compliance and Quality Solutions, IQVIA
3. 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, Integrated Compliance & Technology Solutions, MedTech Center of Excellence, IQVIA
4. Borrow a page from ISO13485:2016 and take a risk-based approach to managing organizational quality and compliance with industry regulations. – Donna Smith, Business Systems Analyst, Quality Compliance Solutions, IQVIA
5. 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, Quality Compliance Solutions, IQVIA
6. 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, Integrated Compliance & Technology Solutions, MedTech Center of Excellence, IQVIA
7. 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, Senior Principal, Quality Compliance Solutions, IQVIA
8. 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. Solutions Engineer, Quality Compliance Solutions, IQVIA
9. 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, Head of QA and Validation, Quality Compliance Solutions, IQVIA
10. 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, Technology, IQVIA
11. 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! – Keith Pensabene, Global Head of Sales, Quality Compliance Solutions, IQVIA
12. 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. Solutions Engineer, Quality Compliance Solutions, IQVIA
13. Drive continuous improvement through the supply chain. – Joshua Centner, Associate Director, Sales Engineering, Quality Compliance Solutions, IQVIA
14. 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, Founder & CEO, Blue Mountain Quality Resources
15. 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, Quality Compliance Solutions, IQVIA
16. Manage and mitigate risks efficiently throughout the value chain, and make sure processes, systems, and resources are aligned. – Florian Czaszewicz, Sr. Solutions Engineer, Quality Compliance Solutions, IQVIA
17. 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, Integrated Compliance & Technology Solutions, MedTech Center of Excellence, IQVIA
18. 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, Quality Compliance Solutions, IQVIA
19. Increase utilization and efficiency of quality processes through process harmonization within an electronic Quality Management System (QMS). – Josh Centner, Associate Director, Sales Engineering, Quality Compliance Solutions, IQVIA
20. Use a Quality Management solution platform as an enabler to support objectives, improve performance and achieve business success. – Florian Czaszewicz, Sr. Solutions Engineer, Quality Compliance Solutions, IQVIA

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.

Share these resolutions with your colleagues as you strive for a successful 2020. A commitment to Quality Compliance is a resolution worth keeping.