Life Sciences
We are committed to delivering digital engineered solutions that make pharmaceutical processes efficient, safe, and sustainable. Starting from and improving the processes designed to comply with regulations.
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Helping to solve your manufacturing challenges:
- Development cost and time to market (data analytics and knowledge management)
- Constraints linked compliance (Quality by Design)
- Improving process efficiency (through quality and cost control)
- Adapting to patient centred care (personalised medicines)
- Target carbon neutrality
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 aroun 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 wit 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.
Discuss your needs and regulatory requirements with a Life Sciences specialist
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). Te 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
Applications
Our application approach starts with GMP regulations and guidance to identify the Critical Process Parameters (CPPs), followed by our suggested technology, architecture and services designed to offer efficiency, robustness, or sustainability advancements, covering processes such as:
- Cold Chain
- Bioreactor
- HVAC
- Climatic Chambers
Digital Engineered Solutions
A DES is a comprehensive set of predefined Good Engineered Practice and Qualification (according to GAMP) documents, best-of-breed technologies, processes, and configuration designed to reduce project execution costs, risks, and time-to-market for applications such as:
- Chemical Fume Hoods
- Environmental Monitoring System
- Freeze Dryers
- Sterilizers
- Clean in Place/ Sterilize in Place
- Water and Water Distribution (DW, PW, WFI)
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