Regulatory information management (RIM) is an important part of the quality compliance management process for life sciences companies. Today, RIM can help life sciences companies modernize their immediate function globally, deepen strategic partnerships, and streamline regulatory pathways. These initiatives help companies expedite the approval of new products in all markets and ensure that existing products are compliant. By modernizing RIM, companies can harness this vital asset as an enterprise asset.
Complexity of life sciences regulatory information management
Today's life sciences organizations face an increasing complexity of managing regulatory information and documents. The research, development and regulatory processes can generate hundreds of thousands of documents, which must be managed securely. Furthermore, organizations must adhere to regional and country-specific regulatory requirements. In addition, they must handle multiple stakeholders, partner organizations, and many types of information.
With the growing complexity and evolution of life sciences business processes, a streamlined approach to regulatory information management (RIM) can provide long-term business benefits for life sciences companies. This approach allows for improved data management, more informed decisions, and greater time savings. Life sciences companies must make sure they have a comprehensive RIM solution in place to meet all of their regulatory requirements.
As costs continue to rise, regulatory information management becomes an increasingly complex challenge for life sciences companies. This complexity is exacerbated by the fragmented nature of data, which is stored in multiple systems and supported by inefficient software applications. This complexity leads to increased risks and increased cost. For instance, bringing a new drug to market costs upwards of $800 million to a billion dollars. In addition, a single successful clinical trial could mean the difference between winning or losing a drug to a competitor.
Today, life sciences organizations have a need to optimize their processes and lower overheads. However, despite the high volume of data generated, most companies lack visibility and accuracy. The lack of visibility and accuracy in data can lead to bottlenecks and unnecessary cost.
Impact of updated CSA guidelines on quality compliance management
A few days back i.e. on September 13th, USFDA issued draft guidelines on CSA (Computer Software Assurance) for Production and Quality Software. You may review the guidance document here.
CSA guidelines are intended to improve regulatory information management in life sciences organizations. They focus on critical thinking, streamlined-validation processes, data integrity, and operational efficiency. As a result, they are designed to help organizations save time, money, and resources. They also provide measurable Key Quality Attributes for compliance.
The new guidelines also aim to improve software development and testing efficiencies. The goal is to reduce error-prone manual processes and increase quality through sophisticated information technology and data solutions. CSA also aims to improve risk-based assurance by implementing critical thinking early in the development process and leveraging vendor documentation during validation. This process results in a reduction of software development and validation costs, documentation and testing time.
While CSA is not a new concept, it does require organizations to update their processes in order to keep pace with the CSA's evolving regulatory information management requirements. For example, CSA is designed to simplify the use of non-product software systems while maximizing testing efforts and minimizing documentation. It has a focus on testing for higher confidence in system performance. While CSA is intended to be guidance, the CSA principles apply to 21 CFR Part 11. The key to compliance is understanding the level of risk for each system.
Organizations must create a change management plan to help people adapt to the new guidelines. By the way, I have a separate post touching upon transition from CSV to CSA. You may check it out here. This change management plan should include a training and communication program to ensure all team members understand the new concepts. These concepts include critical thinking, risk-based thinking, data integrity, and value-add activities.
- Challenges in Modernizing Life Sciences Regulatory Information Management Systems
- USFDA Guidance on Life Sciences Regulatory Information Management
- Economic Impact of Life Sciences Regulatory Information Management
- What are the drawbacks if Regulatory Information Management (RIM) of life sciences organizations is not modernized?
- Modernize regulatory information management to improve operational excellence in life science organizations
- How to Overcome Challenges in Life Sciences Regulatory Information Management
- Benefits of modernizing life sciences Regulatory Information Management
- Transitioning from Computer Software Validation (CSV) to Computer Software Assurance (CSA)
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Categories: Life Sciences | Operational Excellence
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