All companies are under a lot of pressure right now. COVID-19 has turned the world upside down with how we live and interact with each other, how we work and communicate, and how we move around and travel. Every aspect of our lives is affected. Politics, business and healthcare: three threads that must now be tightly interwoven. Each is increasingly reliant on the other, and that reliance has brought changes that were unimaginable at the start of this year.
While organizations globally continue to contend with the economic contraction triggered by the COVID-19 pandemic, some are already considering what they can do now to get ahead of the crisis. These organizations are focusing on ways to transform to achieve a competitive advantage and help create greater resilience in a post-crisis world. Some key tactics include: launching programs for innovation or new business, renewing processes or tools, changing leadership and finding new ways to work and collaborate together to meet unimaginable new challenges.
All companies, regardless of industry, must comply with regulations from: FDA, FAA, OSHA, EPA, EU, ITAR/EAR, 21CFR Part 11 (FDA), cGMP, RoHS, WEEE, ELV, REACH, APQP, AS9100, ISO/TS 16949, QS9000, ISO 9000, CAPA, NCR, CDRL, SDRL, ECR/ECO/ECN, and BTO/CTO/ETO or PCI DSS (financial industry). With the current upheaval, some business leaders may have lost focus on keeping up with compliance requirements. A good regulatory compliance program has positive benefits and outcomes for businesses. Regulations protect consumers’ rights, health, and safety while ensuring minimum standards for products and services. It is clear that COVID-19 is changing the way people interact and work. After Coronavirus subsides and life begins to return to normal, what will this "normal" look like? What new regulations will go into place? Can some of the new regulations be a business-building tool?
How ENOVIA is Helping
By leveraging ENOVIA Regulatory Affairs Manager during the current crisis, some businesses have worked faster and more efficiently than they dreamed possible only a few months ago. ENOVIA Regulatory Affairs Manager is helping businesses stay on track with their submissions. It makes it possible for organizations to manage global market registrations, product identification processes and submissions throughout the product lifecycle. ENOVIA Regulatory Affairs Manager aids organizations in maintaining compliance in finished products as well as meeting regulatory standards throughout development.
What's Next
Companies need to go further, by enhancing and expanding their digital threads. It is clear that the changing regulatory landscape will affect manufacturers. Regulatory Affairs Manager provides the platform to meet the requirements. It manages and tracks product details required for product registration and post market surveillance. By leveraging this tool, organizations can:
- Quickly and intuitively centralize registration-related information across all geographies
- Eliminate duplicate data entry
- Automate many of the manual, repetitive steps slowing today’s processes
- Prepare, submit, approve and manage submission data seamlessly and efficiently
Regulatory Affairs Manager digitizes and institutionalizes best practices for managing product marketing and registration lifecycles from planning, preparation, submission and approval to reporting events post market.
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