Consistent Documentation

Generate and Maintain Compliance with Automated Documentation

Frame-by-Frame® technology supports your team by automating technical writing, reducing manual effort while ensuring accurate and consistent documentation.

Because every output is derived directly from the Digital Process Model, your documentation is inherently accurate, data-driven, and ready for regulatory review.

Trusted by the industry

We decode complex aseptic knowledge into precise digital data. This automation replaces manual drafting with risk-based documentation leveraged by technology.

The result is a faster, safer path to compliance that scales across your entire organization.

Automated Documentation

Consistent Documentation

High Traceability

Scientists in a clean, efficient pharmaceutical production lab adhering to GMP regulations, illustrating the seamless integration of innovative technologies.

What Gets Delivered

Synchronized with the Digital Process Model, Frame-by-Frame® enables automated

  • Work instructions
  • Risk assessment records
  • Compliance documentation
  • Materials for validation work

By serving as a single source of truth, the Digital Process Model ensures that any updates are automatically reflected across all documentation, keeping your quality systems consistent, accurate, and fully aligned without manual work.

How It Works

Consistent Documentation is part of our integrated four-step process, from Digital Process Model to Risk-Based Decision-Making and Effective Training.

Digital Process Model

The Digital Process Model captures all interactions between equipment, operators, and the environment to ensure consistent and scalable modeling.

Risk-Based Decisions

The Digital Process Model and Frame-by-Frame® database automatically identify hazards to generate a structured risk assessment.

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
David Talmage
David Talmage
Vice President Education
PDA
“Normally, there is a certain subjectivity in training. With the Simulator the judgement on mistakes is transparent, and reproducible.”
Alexander Stoll
Alexander Stoll
Vice President – Aseptic Technique Fresenius Kabi
“The virtual reality environment of the Simulator allows our operators to make mistakes, see consequences and learn from them.”
Linda Reijinga
Linda Reijinga
Team Lead QA IT Systems, Training and Reporting Ferring
“In critical aseptic environments, employee qualification is crucial. Innerspace provides the effective training package that complements our program.”
Norbert Gürke
Norbert Gürke
Head of Technical Management for Cleanroom Cleaning | Piepenbrock
“Since the start of our collaboration 5 years ago, Innerspace made enormous progress in establishing outstanding training tools.”
Guenther Gapp
Guenther Gapp
Independent Consultant
Gapp Quality GmbH
“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.”
Olivier Guillon
Olivier Guillon
Engineering Department
Etrema
“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
Glenn Wright
Glenn Wright
President and CEO
PDA

FAQ’s

Reports are automated but always reviewed by Innerspace experts before delivery. This ensures that the content accurately reflects the process and meets the required documentation standards — combining the efficiency of automation with the reliability of expert oversight.

By centralizing all process-related documentation in a structured knowledge hub, teams can quickly retrieve the information needed during inspections. Every report includes full traceability back to the underlying risk data, providing clear, objective evidence for regulatory authorities.

All documents originate from the same underlying Digital Process Model, ensuring that risk findings, control measures, and qualification criteria remain consistently linked and fully traceable across every report.

Yes. Because documents are tied to the Digital Process Model rather than being maintained manually, updates can be reflected systematically. Changes are version-controlled and traceable, reducing the risk of outdated documentation circulating across teams.

Documentation powered by Frame-by-Frame® is designed to support the requirements defined in both frameworks. Reports include standardized risk scoring, traceable decision logic, and objective process data — providing the structured evidence that regulators expect under a risk-based quality management approach.

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.

T: +43 660 140 0971
E: office@innerspace.eu

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