Automated Process ModelingAssessment

with our Frame-by-Frame Solution

Our Frame-by-Frame Solution automates process design and risk assessment in aseptic manufacturing, cutting production risks and time-to-market while ensuring quality and compliance.

Automated Process

ModelingAssessment

with our Frame-by-Frame Solution

Our Frame-by-Frame Solution automates process design and risk assessment in aseptic manufacturing, cutting production risks and time-to-market while ensuring quality and compliance.

Status Quo in Pharmaceutical Manufacturing

Pharmaceutical manufacturing demands the highest standards of quality, safety, and regulatory compliance. The production of every new drug, every new therapy and every new medical device requires the development of complex pharmaceutical manufacturing processes that can take months, sometimes years. Subjectivity in process design and risk assessment often leads to risks that can have serious consequences for patient safety and product availability.

With rising new drug approvals and demand, the pharmaceutical manufacturing industry is facing the challenge to accelerate and scale manufacturing, adapt fast to new market demands and meet regulations without compromising product quality.

62% of drug shortages result from quality issues, and advanced manufacturing can help to address supply disruptions.

Michael Kopcha

Director of the Office of Pharmaceutical Quality in the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)

Status Quo in Pharmaceutical Manufacturing

Our Solution for Safer & Faster Manufacturing

We solve fundamental problems in aseptic manufacturing by offering an automated, data-driven approach that integrates all aspects of process design, risk assessment and knowledge management. This reduces time-to-market and production risks while enhancing quality and regulatory compliance.

Our Frame-by-Frame Solution is enabled by the Process Frame Library, a central database containing detailed information on thousands of unit operations and process steps. We leverage this extensive data to generate multiple Process Model variants. By conducting a thorough Risk Profiling and comparing the variants, we can identify the most effective and efficient process that contains the least amount of critical risk. To implement the optimized process, our Knowledge Management system generates process documentation, provides quality monitoring guidelines and offers a tailored training program for personnel.

Frame-by-Frame Solution
Frame-by-Frame Solution

Key Benefits of Frame-by-Frame

Automated & Objective Process Modelling
Automated & Objective
Process Modelling

Our Frame-by-Frame Process Modelling speeds up decision-making in process design and improvement to a matter of weeks, not months or years. By generating and comparing multiple Process Model variants, we save manufacturers precious time and resources to get more medicines to patients faster and with less risk.

Automated & Objective
Risk Profiling
Our Frame-by-Frame Risk Profiling systematically identifies hazards at a micro level and provides an objective quantification of risk. By integrating multiple factors such as hazard severity, likelihood of occurrence, and detectability, this system enables precise risk assessment. We provide a comprehensive QRM report that includes risk assessment and control, aligned with industry standards and regulations.
Automated & Objective Risk Profiling
Automated & Objective Risk Profiling
Automated & Objective
Knowledge Management
Our Frame-by-Frame Knowledge Management system generates process flowcharts, SOPs, quality monitoring guidelines, and a tailored training program that are always up-to-date and consistent with the process design. This ensures reliable process execution and scalable knowledge transfer, thereby enhancing quality assurance.
Contact Us

Want to learn more about our Frame-by-Frame Solution?

Contact our regional teams to get further details!