Records Management

PRODUCTS

  • There is a growing demand for the sterilization of small-molecule parenteral products, including heart medications, eye drops, analgesics, and antibiotics, as well as intravenous solutions, such as glucose, potassium, and saline. To ensure patient safety, these drug products and related instruments commonly used in hospitals must be thoroughly sterilized after being manufactured. Known as "terminal sterilization," this highly efficient process ensures that no microbial contaminants like fungi or bacteria are present when the product is used.

    If you have a product that needs to be terminally sterilized, we can help.

  • We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.

  • Controlled by software designed to meet 21 CFR Part 11 regulatory standards, Prometheus Panta C facilitates data integrity through distinct user access groups, while Active Directory integration provides centralized user authentication. Features such as electronic signatures, electronic records, and comprehensive audit trails further strengthen regulatory alignment.

  • “Services” and “support.” What do those words mean in the life science manufacturing industry? The truth is, they’re quite subjective—and relative to each company. Here’s how we define services and support at Cytiva.

  • RImanager centralizes regulatory and product data, integrates with production, and streamlines planning, tracking, and approvals to bring new drugs to market faster and reliably.

WHITE PAPERS AND CASE STUDIES

NEWS