Validation is a documented process to prove that equipment, systems, spreadsheets, processes, and procedures work safely and efficiently to protect patients and clients, and to ensure product quality and data integrity.
Many Life Science companies (Pharmaceuticals, Medical Devices, Biologics, and Diagnostics) use the SAP® platform as ERP (Enterprise Resource Planning) to manage their data and processes in an integrated way.
The integrity of critical data in Life Sciences industries is an issue that, if taken with the care deserved and required by regulatory agencies, keeps the company aligned with Good Manufacturing Practices and avoids issues detrimental to the production process and business.
Verification is a process that determines the quality of a product. This step includes all the activities associated with high-quality production, (i.e., testing, inspection, design analysis, specification analysis, etc.).
Industrial automation is defined as the use of equipment, hardware, and specific software to automate an industrial process: whether production optimization; control and traceability; monitoring; analysis performance and tracking; among others.
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