Navigating the challenges of document review in the Life Science industry
Nicola Pearson 
Date published: Jul 27, 23
The life science industry, encompassing pharmaceuticals, biotechnology, and medical devices, is highly regulated and operates in a complex landscape. As part of their operations, companies in this sector must undertake thorough document review processes to ensure compliance with stringent regulations and maintain the safety and efficacy of their products. However, reviewing documents in the life science industry comes with its own set of challenges. In this blog, we will explore some of these challenges and discuss potential strategies to overcome them.
Stringent regulatory requirements
The life science industry is governed by strict regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. These regulatory agencies impose rigorous guidelines on data integrity, quality, and compliance. Document review teams must ensure that all documents meet these regulatory standards to avoid penalties, delays, or product recalls.
To overcome this challenge, it is crucial for companies to establish standardized review processes and provide adequate training to reviewers. Quality control checks and regular audits should also be conducted to maintain compliance and identify any potential gaps or issues early on.
Document versioning and conflicts
Commonly used collaboration tools, such as SharePoint, offer version control to manage changes to documents effectively. However, versioning can become challenging when multiple users are collaborating simultaneously, or when someone downloads the document to work in offline mode. Conflicts may arise when two or more individuals make conflicting changes or save different versions of the same document. Resolving these conflicts can be time-consuming and may result in the loss of valuable work.
Ideagen PleaseReview provides a structured, stable and robust environment for document collaboration. With secure version control, document contributors can always be confident that they are working on the most up to date version. Rigorous activity tracing means that no contribution can be overwritten or lost. Everything is captured in a one-click audit report, which also doubles as a handy agenda that document owners can use in Comment Resolution Meetings (aka CRMs).
Performance and slow load times
Depending on the configuration and infrastructure of your existing collaboration environment, users may experience slow load times and performance issues, especially when dealing with large files or complex document libraries. Waiting for documents to load or navigating through slow interfaces can be frustrating and impact productivity.
Ideagen PleaseReview is custom-built for reviewing content-rich scientific documentation. Users report that it is a much sturdier and robust tool when compared with commonly used collaboration environments. It can support very large documents and can easily withstand two – 200+ users working together in real-time.
Vast amounts of data
One of the primary challenges in document review within the life science industry is the sheer volume of data involved. Companies in this sector generate a significant amount of documentation, including clinical trial data, regulatory submissions, standard operating procedures, and adverse event reports. Reviewing and analyzing this vast amount of information can be a time-consuming and resource-intensive task.
To address this challenge, companies can leverage advanced technologies like artificial intelligence (AI) and machine learning (ML) algorithms. These technologies can assist in automating document sorting, categorization, and extraction of relevant information, enabling reviewers to focus on critical areas that require human expertise.
Conclusion
Document review in the life science industry is a critical process that demands meticulous attention to detail, adherence to regulatory requirements, and effective collaboration between reviewers, scientists, and legal professionals. By recognizing and addressing the challenges associated with document review, companies can streamline their processes, enhance compliance, and ultimately contribute to the development of safe and effective products in the life science industry. Embracing emerging technologies and adopting best practices will play a pivotal role in overcoming these challenges and driving innovation in this dynamic sector.
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