3 Critical Warning Signs You're About to Fail Regulatory Compliance in Life Science (and How to Avoid it).
Are you working on a new drug application, a complaint or are you responsible for quality control? The nightmare: an audit finding can cause penalties or even a drug submissions suspension and your company would suffer significant financial losses. Unfortunately, this happens too often in the Life Science industry. According to the Ponemon Institute, non-compliance costs an average of $5.2 million per year.
But don't worry - regulatory compliance can be a stress-free experience. We'll explore three critical warning signs that indicate you might be on the path to regulatory compliance failure. Most importantly, we'll provide practical solutions to steer clear of such pitfalls.
Warning Sign #1: Inconsistent Document Management for Regulatory Requirements
One critical warning sign that you’re about to fail regulatory compliance is inconsistent document management of critical documents that must adhere to stringent regulatory requirements.
This occurs when documents related to clinical trials, drug development, and other life science activities are not being managed consistently across the organization. It can lead to errors, omissions, and inconsistencies that can create compliance issues.
Solution
To combat the challenges of document management, it is crucial to implement a specialized Document Management System (DMS) designed specifically for the life science industry.
Such a system should offer features like controlled document workflows, electronic signatures, audit trails, and robust security measures. A life science-focused DMS streamlines document organization, version control, and collaboration, ensuring regulatory compliance throughout the document lifecycle.
Check out our customer story about leveraging OpenText Content Suite solution for our client in Life Science industry to rollout the document management system worldwide with full functionality and business support.
Warning Sign #2: Poor Quality Management
Quality is essential in the life science industry. Without effective quality management processes, compliance failures are likely to occur. Inadequate oversight, lack of quality control, and deviations from standard operating procedures can compromise product safety, efficacy, and patient well-being.
Solution
To avoid compliance issues related to quality management, implement a comprehensive Quality Management System (QMS). A QMS tailored to the life science industry should include processes for document control, deviation management, change control, risk assessment, and training records. By implementing a robust QMS, you establish a framework for maintaining high standards, ensuring compliance with regulations, and mitigating risks across your operations.
Discover in this case study how we have helped our client in Life Science industry to improve existing Change Control Workflows run based on OpenText Content Server (QMS) and to implement additional Change Control Workflows in sites including e-sign and extended reporting functionality.
Warning Sign #3: Poor Change Control Management
The life science industry operates in a rapidly evolving regulatory landscape. Regulatory authorities frequently update guidelines, introduce new requirements, and tighten enforcement measures. Failing to stay abreast of these changes is a recipe for compliance failure. If you're caught off guard and fail to align your processes, documentation, and operations with the latest regulations, you'll find yourself out of step with compliance expectations.
Solution
To proactively address regulatory challenges, it is essential to stay vigilant and embrace regulatory intelligence. Establish processes to monitor regulatory updates, engage with industry associations and networks, and leverage technology solutions that provide automated regulatory monitoring. By staying informed, you can anticipate changes, adapt your processes, and ensure ongoing compliance.
To proactively address regulatory challenges, it is essential to stay vigilant and embrace regulatory intelligence. Establish processes to monitor regulatory updates, engage with industry associations and networks, and leverage technology solutions that provide automated regulatory monitoring.
We know compliance is a pain and costs money, so how to find balance between too expensive but still compliant is a constant concern. This is where the importance of the right Enterprise Content Management Solutions becomes evident. By staying informed, you can anticipate changes, adapt your processes, and ensure ongoing compliance.
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