To properly approach regulatory assessment, organizations must present accurate and up to date documentation, thorough meeting planning, assessment preparedness and competitive intelligence as a minimum.
Regulations for reporting within the Medical Devices and Biopharma industries are constantly subject to alteration and reform. A current example of this is the expanding reporting obligations, as part of the Physician Payments Sunshine Act.
These will require that Medical Device and Biopharma manufacturers disclose any payments or transfers of value made to physicians or teaching hospitals. This will take full effect on January 2022, meaning that Medical Device and Biopharma organizations must start tracking payments and other transfers of value from January 2021, ready for reporting in March 2022.
A recent study identified and detailed five levels of maturity for compliance integration within Life Science organizations: reactive, or defensive compliance; passive, or superficial compliance; operational, or transactional compliance; strategic, or embedded compliance; and holistic, or fully integrated compliance.
These five stages of compliance maturity illustrate the considerable gap between organizations that recognize compliance at the forefront of business decisions and those that fail to consider compliance as an integral part of their product development process.
There are no shortcuts when it comes to quality and regulatory compliance. So, let’s start by assuming that a mutual respect between manufacturers and regulators is prerequisite to your product’s success.
With the common goals of ensuring patient protection, improving patient outcomes and reducing healthcare costs, regulators are not there to limit your time to market, nor profitability. In fact, they’re there to ensure that your product fulfils its purpose to the highest possible standard.
Regulatory documentation is constantly under review. So, it’s vitally important to ensure that your submissions are compiled based on current regulatory standards. Introducing a digital document and quality management system can help you to stay in control of your data. So, here are five top tips to ensure you keep up quality document management practices:
A central repository for all documents and workflows ensures the use of consistent templates with standardized attributes. Quality Management Systems, such as Dassault Systemes’ ENOVIA Quality & Compliance Management on the 3DEXPERIENCE platform, help organizations coordinate and direct activities to meet regulatory requirements.
Secure, effective collaboration on documents and content from a single source of truth ensures traceability of ownership. While immediate access to data and documentation reporting enables teams to decrease inspection time through standardized and streamlined processes.
Encouraging a culture of quality within your organization is key to maintaining Continuous Quality Improvement (CQI). The best way to ensure user engagement is to provide a simple, intuitive solution that allows for automation and standardization in your processes.
The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.
Within validated systems, change process management needs to be held to a high degree of accuracy. And ensuring a single source of truth within a secure file structure at each file server and shared folder levels is crucial. Document changes must be mapped, and external security issues must be addressed proactively rather than reactively.