Evolving Regulatory Landscape
Due to emerging technology and the global push for more environmentally friendly products, the regulatory world is changing at a rapid pace. Industry regulations and standards are constantly updated to address new product performance, safety, security, and sustainability criteria. Consequently, manufacturers must regularly reevaluate their design, validation, and production processes to keep up with evolving requirements and ensure compliance.
Implementing strong design controls and corrective and preventive action (CAPA) processes is a necessity for life sciences manufacturers looking to comply with the quality system directives set forth by the FDA and ISO. They must also gather and maintain more extensive clinical evidence to support the product’s safety and performance claims and comply with the latest European Union (EU) medical device regulations (e.g., MDR and IVDR). Ensuring proper security controls and protection for the export of ITAR– and EAR-related data is a priority of companies in the aerospace and defense industry. And companies across all sectors must source compliant components and materials if they want to adhere to environmental regulations such as REACH, RoHS, and WEEE.
In essence, having a system to effectively track, manage, and report compliance evidence for these various regulations is critical to helping companies meet their NPD timelines and fulfill commitments to customers.
Economic headwinds are impacting consumer demand and manufacturers’ ability to source parts and get products to market. More companies are having to lay off some of their workforce to address shrinking demand in our weakened economy. These conditions ripple through the entire supply chain, putting an additional strain on companies’ abilities to deliver products to market.
To compound matters, many companies have adopted remote work practices as a result of the COVID-19 pandemic. With internal and external teams scattered across the globe in multiple time zones, it is harder to keep everyone on the same page throughout the NPD process.
What barriers does your organization face with new product innovation?