Life Sciences

Catalyzing the digital transformation in the regulated environment

Embed quality by design in the early stages
Balance the constraints of QTPPs, CQAs , and CPPs, as introduced by PQS with the need for an accelerated scale­up process.

Digitalize the complete project life cycle
Align a validation master plan around the need for flexible process requirements as well as economic and business needs. For example, by adopting paperless documentation management and ‘digital twin’ technology.

Manage changes with minimal impact
Digital engineered solutions allow for easier updating of existing equipment and problem solving of process issues, with minimal, or no impact on SOPs and the validation state.

Automate modular process lines
Increase modularity and flexibility by easily integrating stand-alone assets into a unified plant model designed to meet data integrity ALCOA+ principles.

Meet your sustainability goals
Lifecycle development and manufacturing enhancements in pursuit of 100% sustainability and a circular economy.

What is GxP?

GxP is a general abbreviation for the “good practice” regulations. The “x” stands for the various fields, like Laboratory (GLP), Manufacturing (GMP), Engineering (GEP), and Documentation (GDP). The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The current GMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. Good Engineering Practice (GEP) consists of proven and accepted engineering methods, procedures and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations.

Learn about EudraLex GMP Annex 1 >

Learn about ISPE GAMP 5 >