24 de October de 2024

Data Governance for AI

Life Sciences companies, particularly biopharmaceutical and medical product companies, are highly regulated and need to prove that their product and its manufacturing and development processes are robust.Patient safety is impacted by the integrity of critical records, data, and decisions, as well as aspects related to the physical attributes of the products.
4 de October de 2024

How to Validate AI in GxP Applications for Life Science Companies

The integration of Artificial Intelligence (AI) into the Life Sciences industry brings innovative potential, from drug discovery to personalized medicine. However, incorporating AI into GxP (Good Practice) environments, which are governed by regulations to ensure product safety and efficacy, introduces additional challenges in AI validation.
26 de September de 2024

Streamlining LIMS Validation with Agile Methodologies for GxP Compliance

Laboratory Information Management Systems (LIMS) are specialized Quality Control systems designed to collect, manage, and streamline the flow of analytical data in laboratories. They handle tasks such as the approval of analyses, ensuring the traceability of samples and reagents, and maintaining records for equipment maintenance and other critical laboratory operations.
26 de June de 2024

What is UDI (Unique Device identification)? Principles for system design and operation – medical devices

Principles for system design and operation – medical devicesUDI is based on a sequence of numeric or alphanumeric characters created using worldwide accepted device identification and coding standards. Allows unequivocal identification of a device on the market.
8 de April de 2024

IT Infrastructure Qualification for Small & Medium Medical Devices Companies (and SaMD): ISO 13485:2016 Compliance

ISO 13485 is a globally recognized set of standard quality management system (QMS) requirements applicable to companies engaged in the design, production, installation, servicing, and manufacturing of medical devices.