Managing Regulatory Compliance in Life Sciences
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Life Sciences Review | Wednesday, December 16, 2020
To properly approach regulatory compliance, life sciences organizations must present accurate and up to date documentation, thorough planning, assessment preparedness, and competitive intelligence.
FREMONT, CA: Embarking on a journey to push the boundaries of innovation to develop new products, life sciences companies have to address an increasing number of regulatory requirements. While the life sciences industry has continued growth and advances by drafting compliance and business strategies flexible to the legal landscape, they continue to face hurdles in growth, quality, and overall compliance. This is why identifying, analyzing, and reducing compliance challenges are essential in developing an effective compliance strategy to future-proof business. Here is how to manage regulatory compliance in life sciences.
Regulatory documentation is constantly under review. So, it’s vitally important to ensure that submissions are compiled based on recent regulatory standards. Using a digital document and quality management system can help life sciences to stay in control of the data. A central repository for all data and workflows ensures the use of consistent templates with standardized attributes.
Quality Management Systems help organizations coordinate and direct activities to meet regulatory needs.
Secure, effective collaboration on data and content from a single source of truth ensures traceability of ownership. Simultaneously, instant access to data and documentation reporting allows teams to decrease inspection time through standardized and optimized processes. Encouraging a culture of quality within the firm is vital to maintaining Continuous Quality Improvement (CQI). The best method to ensure user engagement is to offer a simple, intuitive solution that allows for automation and standardization.
The company's solution should be seamlessly configured, maintained, and updated, breaking from a strong reliance on costly programmers, consultants, and specialized IT resources to make an alteration or add a step to the process. Within validated systems, change process management requires to be held to high accuracy. And ensuring one source of truth within a secure file structure and shared folder levels is vital. Document changes must be mapped, and external security problems must be addressed proactively rather than reactively.
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