Digital Process Model
Traceable & consistent process Mapping
Creating a resilient manufacturing process starts with understanding the process as a whole, including its smallest interactions. We build a Digital Process Model of your operations to capture and map every interactions between people, equipment, materials, and environment.
By transforming real-world execution into a structured, observable model, we provide the foundation for predictive decision-making, traceable risk evaluation, and consistent process design.
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 We Build It
Our experts work with your existing process documentation, facility layouts, and videos of your operations that were recorded on-site. No software installation or internal IT integration is required on your side.
Using Frame-by-Frame® technology, our team maps every interaction between personnel, equipment, materials, and the environment. 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
By making every process interaction observable and structured, the Digital Process Model enables your team to identify and address risks before they materialize on the shop floor.
Every interaction captured in the model is traceable, documented, and aligned with EU GMP Annex 1 and ICH Q9, providing the evidence base regulators expect.
Because the model is built on standardized Frame-by-Frame® libraries, it can be extended and replicated across facilities, products, and teams without starting from scratch.
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
Our Frame-by-Frame® method 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 on your side.
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.
Our 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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