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 centered care (personalized medicines)
  • Target carbon neutrality 

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Catalyzing the digital transformation in the regulated environment

  • Embed quality by design in the early stages: Balance the constraints of QTTPs, 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 plant around for easier updating of existing equipment and problem solving of process issues, with minimal, or no impact on SOPs and validation state. 
  • Automate modular process line: Increase modularity and flexibility by easily integrating stand-alone assets into a unified plant model designed to meet data integrity ALCOA+ concept. 
  • Meet your sustainability goals: Lifecycle development and manufacturing enhancements in pursuit of 100% sustainability and 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). 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.

 

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 Systems
  • Freeze Dryers
  • Sterilizers
  • Clean in Place/ Sterilize in Place
  • Water and Water Distriution (DW,PW,WFI)

Services

Services designed to help meet the quality standards and operating procedures required by the Life Sciences industry.