Background

Literature monitoring is the process of searching published literature for data about products. Sources of literature may be published newspapers, internet websites, medical journals, periodicals, radio broadcasts, or television broadcasts. The information generated from these sources can be commonly referred to as medical literature, regardless of the source. Literature must be collected because it presents the "state of the science" or accumulated knowledge on a specific topic. The information collected can also be used to inform professionals and patients of the best available evidence when making healthcare decisions, influence policy, and identify future research priorities for a particular company. The key challenge inherent in the storage and management of literature is maintaining the integrity of the information while ensuring proper document accessibility and regulatory compliance. This involves several critical aspects:

  1. Collection of Data: Information regarding products should be stored separately, preferably in a dedicated repository distinct from other company documents, to enhance the efficiency of information gathering and retrieval. This requires a robust system for categorizing and segregating documents.
  2. Access Control: Strict access controls must be implemented to ensure that only authorized personnel can view potentially sensitive information and categorize collected literature. This includes setting permissions and audit trails to monitor who accesses what information and when.
  3. Regulatory Compliance: Ensuring compliance with regulatory requirements when working with products such as Good Clinical Practice (GCP), GDPR, and other relevant guidelines is essential. This includes maintaining secure, traceable, and auditable records.
  4. Document Integrity: Maintaining the integrity and confidentiality of product information while enabling necessary updates and collaboration can be challenging. This requires distinct control of user access and user permissions. This may also encompass certified translations of literature to or from multiple languages to ensure the integrity of the document content.