Navigating the Regulatory Landscape: How Auto-Classification Simplifies Compliance in Life Sciences

May 10, 2023

5 minute read

The life sciences industry is heavily regulated to ensure the safety, efficacy, and quality of medical products and services. Companies must navigate a complex web of guidelines and requirements set by various regulatory bodies, such as the FDA, EMA, and other global agencies.

Compliance with these regulations is crucial for maintaining public trust, protecting patients, and avoiding costly penalties or delays in bringing products to market.

Auto-classification, powered by AI and machine learning technologies, can help organizations manage their documentation and data more efficiently, ultimately simplifying regulatory compliance processes.

Regulatory Requirements and Challenges

FDA, EMA, and other global regulatory bodies: Life sciences companies must adhere to the regulations and guidelines established by various governing bodies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others depending on the region in which they operate.

Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP): Industry-specific guidelines like GCP, GMP, and GLP outline the standards for conducting clinical trials, manufacturing medical products, and performing laboratory testing, respectively.

Penalties for non-compliance: Non-compliance can result in severe consequences, including financial penalties, product recalls, reputational damage, and even criminal charges in some cases.

Auto-Classification for Regulatory Compliance

Document management and categorization: Auto-classification automates the process of categorizing and organizing regulatory documents, ensuring that the correct information is easily accessible when needed for audits or submissions.

Version control and audit trails: Auto-classification helps maintain version control and provides audit trails for all documents, ensuring that the most up-to-date information is available and that historical records are preserved for reference.

Metadata management: By generating and managing metadata, auto-classification simplifies the process of finding and retrieving relevant documents, streamlining compliance efforts.

Download our recently updated guide to learn more about the use cases and benefits of document autoclassification.

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Benefits of Auto-Classification for Compliance

Improved accuracy and reduced errors: Automation reduces the risk of human error and ensures greater accuracy in document management and categorization, leading to more reliable compliance processes.

Streamlined regulatory submissions: Auto-classification speeds up the preparation of regulatory submissions by making it easier to locate and organize required documents, reducing the time and effort involved in the submission process.

Minimized risk of non-compliance penalties: By improving the accuracy and efficiency of compliance processes, auto-classification helps minimize the risk of non-compliance penalties, saving companies time and money.

A Growing CRO Achieves 75% Reduction In Manual eTMF Management

As the number of clinical trials increased for this growing Contract Research Organization (CRO), it has become increasingly more time-consuming for Clinical Research Associates (CRA) to intake and process documentation from multi-site trials resulting in increased project costs and delays. Current industry trend of knowledgeable clinical workers leaving the workforce put additional strain on the organization as it struggled to hire experienced trial management staff.

Company leadership has turned to technology-based solutions to help alleviate manual document processing and classification to boost efficiency and lower costs.

Manual Effort Galore
Often, clinical documentation came in as an email attachment of multiple scanned files assembled into a single PDF. The process required the CRAs to manually:

  • break apart the large document into several smaller PDFs
  • read the contents of each document to figure out where they belonged within the eTMF
  • using standard naming conventions, rename and save each file in the correct eTMF folder
  • add appropriate file attributes to each file.

The Perfect Match
Court Square Group & Adlib teamed up to deliver a content processing & classification software to:

  • intelligently scan the content in each document and assign the metadata
  • classify the documents and identify appropriate locations within the eTMF structure based on metadata
  • leverage standardized file naming structure to eliminate generic file names and make them more representative of the originating source

Automation Heaven
Our solution reduced the time and effort from processing each document manually for 8 minutes to 1-2 minutes to review the results of the classification engine and
accepting the recommendations from the system. We have successfully helped the CRO to:

  • reduce manual effort and time by 75%
  • increase the accuracy of classification
  • improve the CRA’s core responsibility from manual document processing work to more efficient & impactful review work

Watch us review the case study and the autoclassification in action in our recent webinar.

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The role of auto-classification in simplifying regulatory compliance

Auto-classification plays a crucial role in simplifying regulatory compliance by automating document management, ensuring accuracy, and streamlining processes. As a result, life sciences organizations can focus on their core competencies, such as research and product development, while maintaining compliance with industry regulations.

The future of compliance management in life sciences

AI and machine learning technologies continue to advance, auto-classification will become an increasingly important tool for compliance management in the life sciences industry. Embracing these technologies will be essential for organizations seeking to navigate the complex regulatory landscape efficiently and effectively. The future of compliance management in life sciences will likely involve more advanced automation, integration, and collaboration among regulatory bodies, companies, and other stakeholders, ultimately leading to improved safety, efficacy, and innovation in the industry. By adopting auto-classification and other advanced technologies, life sciences organizations can stay ahead of the curve and ensure their long-term success in an ever-evolving regulatory environment.

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