We help to maintain the highest standards by transforming deep industry knowledge into digital training solutions.

Yes, our training solution is aligned with cGMP requirements and is specifically designed to support implementation in regulated environments. As an official partner of the Parenteral Drug Association (PDA) for training course design and delivery, we collaborate closely with leading industry experts who review and validate our content to ensure regulatory relevance and quality.

Our training content reflects the latest EU GMP, FDA 21 CFR Part 211, and ICH guidelines, and is continuously updated to stay ahead of evolving standards.

To further support compliance, we provide ready-to-use validation documentation that simplifies implementation and integration into your existing quality systems. Combined with precise and robust learner progress tracking and audit-ready records, our solution helps ensure your teams are trained to cGMP standards.

Yes, Innerspace provides structured implementation support to ensure a smooth and efficient rollout of the training solution at your
facility. We offer clear blueprints and best practices for integration into your existing training programs and compliance framework.

Our Customer Success team—comprised of training specialists, industry experts, and IT professionals—works closely with your team to tailor the onboarding process to your specific needs. This includes guidance on configuration, deployment and validation.

We also provide ready-to-use cGMP validation documentation, helping you meet regulatory requirements and bring the solution into a validated state with minimal effort.

For our principle-based training solution, we offer robust behavior tracking and analytics to monitor trainee learning progress and ensure training effectiveness.

When integrated with a Learning Management System (LMS), each learner’s progress is stored and visualized within the LMS— providing a comprehensive overview of staff performance across training modules.

Key features include:

• Immediate behavioral feedback during
  training sessions in Virtual Reality,
  reinforcing correct actions in real time.
• Comprehensive post-session summaries
  that highlight strengths and areas for
  improvement.
• Seamless data transfer to the LMS via
  SCORM 2004 (4th edition) or exportable
  as a structured PDF report.
  

This data-driven approach ensures measurable learning outcomes and actively supports your Contamination Control Strategy by identifying behavioral risks and closing knowledge gaps before they impact operations.

The principle-based training content is standardized to ensure consistency, regulatory alignment, and expert-reviewed quality across all training deployments. While the core content itself is not customizable, the solution is designed to be flexible and adaptable to your organization’s needs.

We offer:

• A modular training system that allows you to build role-specific curricula by selecting the most relevant modules for
  different job profiles.
• The ability to choose from different cleanroom environments, such as RABS, Isolators, or BSCs—ensuring the training reflects your operational reality.
• Multilingual support out of the box, including German, English, Italian,
  French, Spanish, Korean, Portuguese and Japanese, allowing global teams to train in their native language and improving knowledge retention across diverse workforces.
  This approach enables scalable, site-specific deployment while maintaining the validated integrity of the training content.

The principle-based training solution is available in multiple languages to support global teams and ensure accessibility across regions. The standard language package includes English, German, French, Italian, Spanish, Portuguese, Japanese and Korean.

We understand the importance of delivering training in the native language of operators to ensure clarity, engagement, and effective learning.

If your organization requires additional languages, we’re open to discuss language extension options upon request, enabling broader and more inclusive deployment across your workforce.

All updates to Innerspace’s training solution follow a formal change control process in line with cGMP expectations. This ensures that any modifications—whether related to content, functionality, or system behavior—are evaluated, documented and communicated appropriately.

Our change control process includes:

• Impact assessments to determine if an update affects validated elements.
• Version control and detailed release notes to ensure transparency.
• Optional update scheduling to allow customers to plan implementation and revalidation if needed.
• Notification and documentation, supporting your internal quality and compliance processes.

This approach ensures that updates enhance the training experience while maintaining compliance with your quality management system and regulatory requirements.

The principle-based training solution is designed to be relevant across a wide range of production environments, even when site-specific procedures vary. It uses authentic, illustrative scenarios within a generic cleanroom setting— such as isolator, RABS, or BSC—to emphasize core cGMP behavioral principles rather than replicating individual production processes.

The training covers fundamental principles, including contamination awareness, the influence of operator behavior in cleanroom environments, aseptic techniques, cleaning and disinfection practices, the concept of first air, and environmental monitoring.

To ensure the training has the intended impact, it is important that the principle-based content is linked to existing internal training materials and procedures. This connection helps operators transfer what they’ve learned into the context of their day-to-day work.

Our implementation team actively supports your organization in mapping the training solution to your existing training program, ensuring alignment with your internal standards and procedures and learning objectives.

This approach supports the development of foundational behavioral competencies that apply across different roles and cleanroom operations. After completing the training, operators gain a clearer understanding of the cleanroom context, which can help them interpret and learn process- specific knowledge more effectively.

We offer a comprehensive, modular training solution designed to support a variety of aseptic operational roles within cleanroom environments. The program focuses on core cGMP principles and operator behaviors that are critical across sterile manufacturing.

Key topics covered include cleanroom behavior, principles of cleaning and disinfection, principles of first air, and fundamentals of environmental monitoring.

To reflect the practical context of different roles and facility setups, customers can choose from three cleanroom environments: RABS, isolator, or BSC. This ensures the training environment aligns with the specific equipment and operational realities of each site.

The modular structure enables organizations to build role-specific curricula, while maintaining alignment with regulatory expectations and best practices in contamination control.

Yes, the Innerspace training solution can be seamlessly integrated with your existing Learning Management System (LMS). We support SCORM 2004 (4th edition), enabling standardized communication between the training content and your LMS platform.

This integration makes it possible to track learner progress and completion status directly within your LMS, store session results to support audit readiness and compliance, and manage all training records alongside your existing internal learning content.

Each training module is divided into submodules, which can be individually embedded into LMS courses—allowing you to configure tailored learning paths for different roles within your organization.

The training content is fully version-controlled, and we provide the relevant validation documentation with each release version to support your cGMP compliance requirements. Our implementation team is available to assist with mapping and integrating the solution into your LMS environment efficiently.