How Artificial Intelligence and Machine Learning Are Transforming Life Sciences Companies, and Why You Need to Keep Up

In the pharmaceutical, biotechnology, and medical device industries, ensuring that computerized systems work correctly is crucial. This is where GAMP5® Second Edition comes in.

In the Life Sciences industry, validation is a crucial process to ensure compliance with regulations, maintain data integrity, and guarantee product safety.

Life sciences companies—pharmaceutical, biotech, and medical device—operate under strict regulations and must validate the consistency of their products and processes.

Industrialized AI refers to taking artificial intelligence (AI) technologies beyond experimental stages and integrating them at scale within an organization’s core operations.

In Life Sciences companies, AI is being used for tasks such as automating manufacturing processes, optimizing clinical trials, analyzing patient data and several other critical applications for the pharmaceutical, biotechnology and medical products industries.

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.

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.

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.

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.