We translate human and machine interaction into data – to support your experts’ decisions.
Co-Piloting Your Aseptic Process Knowledge with Data-Driven Technology
Decoding aseptic manufacturing frame by frame.
Informed decisions rely on precise, process-specific knowledge.
Our Frame-by-Frame® technology enables risk-based decision-making through traceable data, supporting Right-First-Time Execution and accelerating your process lifecycle from design to operational excellence.
Right-First-Time-Execution
Faster Time-to-Market
How It Works
Manufacturing involves complex interactions between humans and machinery. Critical knowledge of these interactions is often fragmented across documentation, personal experience, and team expertise.
Innerspace structures manufacturing process knowledge into a digital
representation that makes implicit knowledge explicit and reusable.
01 Digital Process Model
Capture and Structure
We decode your existing process knowledge into a Digital Process Model, which serves as the fundamental basis for all subsequent steps.
By leveraging Frame-by-Frame® technology, the Digital Process Model maps every interaction between equipment, operators, materials, and the environment. Dedicated Frame-by-Frame® libraries of objects, actions, and hazards ensure that the modeling is both consistent and highly scalable.
02 Risk-Based Decisions
Assess and Control Risk
The Digital Process Model reveals where risks originate and how they propagate through the process.
It enables precise risk assessments, the identification of critical failure mechanisms, and the definition of targeted risk control strategies, supporting a structured and traceable risk-based decision-making approach aligned with ICH Q9 and Annex 1.
03 Consistent Documentation
Generate and Maintain Compliance
Frame-by-Frame® technology enables the automated generation of risk-based documentation, including work instructions, compliance documentation, and materials for your validation work.
Because all documentation is derived from the Digital Process Model, information remains aligned, traceable, and easy to maintain across quality systems.
04 Effective Training
Build and Sustain Aseptic Expertise
The same structured knowledge foundation supports risk-based training for operators and technical teams.
Training focuses on both process execution and the underlying principles, helping personnel understand not only what to do, but also why certain actions are critical for product quality and process integrity.
Key Benefits
Our approach facilitates decision-making based on quantified data, allowing you to get it right the first time while significantly increasing the speed of process qualification and implementation.
Aligned with Annex 1 & ICH Q9
Our system is engineered to meet the highest standards of the industry.
By implementing the guidelines of ICH Q9 directly into our digital workflows, we provide the framework necessary for a robust Contamination Control Strategy (CCS) as required by EU Annex 1.
This alignment ensures that your risk management is a validated process that stands up to the most stringent global inspections.
“Every manufacturing environment has different challenges. Our solutions are designed with modularity, allowing you to select only the components that solve your specific problems.”
What You Can Expect
Process Design & Transfer
>50%
faster time-to-market
Risk Assessment
>70%
reduction in effort
Documentation & Training
>80%
faster delivery
What the industry says about us
“Through the integration of expert insights, regulatory requirements, VR technology and risk profiling data into our course content, we aim to establish a data-driven approach to training by leveraging these resources.” Read more: Press Release 19 June, 2023
“I really like the built-in Frame-by-Frame® risk profiling capabilities that can provide trainees with immediate feedback on errors made.” Read more: Press Release 19 June, 2023
“The virtual reality environment of the Simulator allows our operators to make mistakes, see consequences and learn from them.”
FAQ’s
No software is being installed or required on your end. You receive the project deliverables directly from us, with no IT integration needed.
It is a technology-enabled consulting service. Our proprietary software handles complex analysis, while
our experts provide the strategy and final assessment.
Your current CCS may rely on assumptions or general guidelines. Our Frame-by-Frame® assessment complements it by providing empirical, traceable data directly aligned with EU Annex 1. This ensures your CCS is reinforced with a robust, evidence-based foundation.
This is where the Digital Process Model stands out. Unlike static documentation, it remains flexible and can
be re-run with updated parameters, ensuring your process lifecycle stays seamless and cost-efficient.
Minimal. Once we have captured your processes, our experts handle the analysis off-site, delivering
updates and maintaining alignment with your team.
Traditional FMEAs often rely on subjective judgment. Our data-driven technology reduces subjectivity in
decision-making, transforming personal assessments into objective, quantifiable insights.
We’d love to hear from you
Fill out the form, and one of our experts will get back to you shortly. Whether you have a question or need assistance, we’re here to help.