Frame-by-Frame® – the Digital Process Model
Traceable & consistent process Mapping
Creating a resilient manufacturing process starts with understanding the process as a whole, including its smallest interactions. The Digital Process Model captures and maps every interaction between people, equipment, materials, and the environment frame-by-frame.
By transforming real-world execution into a structured, observable model, the foundation for predictive decision-making, traceable risk evaluation, and consistent documentation is established.
Trusted by the industry
Aseptic manufacturing involves hundreds of interactions between equipment, operators, materials, and the environment.
Most process documentation captures the intent of a process. The Digital Process Model captures the reality, maps every relevant interaction, and serves as the foundation for all subsequent steps.
Precise Process Mapping
Scalable Knowledge Structure
Single Source of Truth
How It Is Built
Working with existing process documentation, facility layouts, and videos of operations recorded on-site, every interaction between personnel, equipment, materials, and the environment is mapped using Frame-by-Frame® technology.
Dedicated libraries of objects, actions, and hazards ensure that every element is captured consistently and aligned with EU GMP Annex 1 and ICH Q9.
The result is a Digital Process Model, expert-supervised and built to scale across your organization. Ready to support risk assessment, compliance documentation, and operator training.
What You Get
Hosted in the Frame-by-Frame® Cloud, you get secure online access to your Digital Process Model, providing a detailed, structured view of your manufacturing processes.
It supports you in understanding the risks associated with each process step, turning process data into actionable insights, and providing teams with a shared source of knowledge for consistent decision-making.
By connecting documents and materials to your Digital Process Model, you keep documentation consistent, up-to-date, and fully traceable as processes evolve.
Interested in automating Quality Risk Management? Contact us to learn how we can assist you.
How It Works
The Digital Process Model is part of our integrated workflow, from Risk-Based Decision-Making to Effective Training and Consistent Documentation.
Risk-Based Decision-Making
The Digital Process Model and Frame-by-Frame® database automatically identify hazards to generate a structured risk assessment.
Consistent Documentation
Frame-by-Frame® automatically generates risk-based documentation directly from the Digital Process Model, keeping all information aligned, traceable, and easy to maintain.
Effective Training
Frame-by-Frame® ensures effective, risk-based training for operators and technical teams.
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
“Normally, there is a certain subjectivity in training. With the Simulator the judgement on mistakes is transparent, and reproducible.”
“The virtual reality environment of the Simulator allows our operators to make mistakes, see consequences and learn from them.”
“In critical aseptic environments, employee qualification is crucial. Innerspace provides the effective training package that complements our program.”
“Since the start of our collaboration 5 years ago, Innerspace made enormous progress in establishing outstanding training tools.”
“I have integrated the VR Simulator at a customers site into an existing training program and was amazed by how easy and fast this project was going.”
“We are thrilled to partner with Innerspace to provide our members and the industry with innovative and effective training solutions that brings the VR cleanroom into any location.” Read more: Press Release 19 June, 2023
FAQ’s
No. Innerspace delivers the Digital Process Model as a fully managed service. Our experts handle all modeling work using your existing documentation and process recordings. There is nothing to install or integrate on your side. Once completed, you receive secure online access to your Digital Process Model, where you can explore, review, and use your process data through the platform.
The timeline depends on the complexity of your process and facility. Our team will provide an estimate following an initial scoping conversation. For most standard fill-finish environments, modeling can be completed within a defined project timeframe agreed upon upfront.
Typically: facility layouts or drawings, existing SOPs or process documentation, and where available, video recordings of the production process. Our team will guide you through exactly what is needed during onboarding.
The model is a living digital representation of your processes. When process changes occur, Innerspace updates the Digital Process Model accordingly. All downstream outputs, including risk assessments, documentation, and training content, are re-synchronized to reflect the updated reality.
The modeling methodology is aligned with EU GMP Annex 1 and ICH Q9. By providing a structured, traceable representation of aseptic processes, it supports the development of robust Contamination Control Strategies and provides the documented evidence base that regulators expect.
Innerspace is Official Partner of the Parenteral Drug Association (PDA) for Designing and Delivering Data-Driven Training Solutions.
Frame-by-Frame®-powered programs enhance PDA’s courses, providing high-quality education even without traditional cleanroom environments.
We’d love to hear from you
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