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.

This covers the overall strategy, helpful tips, and ways to leverage documentation from another unit within the company for maximum benefit.

Welcome to our blog! In this session, we will explore the vital role of suppliers and their collaboration with regulated companies, as well as delve into the world of third-party validation processes.

A startup's path to growth involves numerous obstacles and stages, particularly for those operating in regulated markets such as Medical Devices and Health Tech.

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.

Life Sciences companies face several challenges in developing and keeping their systems updated.

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.

ISO (International Organization for Standardization) is a worldwide organization composed of collaborating groups in more than 160 countries.

Knowledge Management is the process of capturing, distributing, managing, and effectively using knowledge and information within an organization.

As we know, nowadays companies need to have a clear data overview to remain competitive, whether for their projections, risk assessment, and/or opportunities.

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.

The need for remote work increased exponentially during the pandemic. Many industries had already embraced digitalization, but the pandemic forced companies and professionals to adapt more quickly.

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.).

Using a Waterfall model is a very common practice for project delivery of paper-based validation, or validation using a text editor.

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.

Validation Using a Text Editor (e.g., Microsoft Word) is One of The Biggest Bottlenecks in The Regulated Industry.

Although it seems at first that a Requirements Management System (RM) and a Validation Lifecycle Management System (VLMS) are similar, the RM has a limited scope in relation to VLMS conformity.

Activities and changes in consumer behavior are proving that it’s only a matter of time before the use of paper is obsolete.