Dynamics 365 Guides in GxP regulated industries overview

Production companies in regulated industries such as life science, food science, medical devices, and cosmetics are increasingly looking into digital technology to optimize business processes. One excellent example of such digital technology is the use of HoloLens devices together with the Dynamics 365 Guides software.

However, compliance with Good {industry} Practice (GxP) protocols isn't easy. It requires resources, expertise, training, and coordination among different teams and departments. It also poses significant challenges for efficiency, productivity, innovation, and competitiveness. For example, some common issues that pharmaceutical manufacturers face when they follow GxP protocols are human errors and inconsistencies, lack of visibility and collaboration, and inflexibility and inefficiency.

Mixed reality (MR) can address the different challenges. MR encompasses both augmented reality and virtual reality (VR) to create immersive and interactive experiences that include digital overlays on the physical world or a simulated environment. MR can offer benefits for manufacturers in regulated industries who must comply with GxP. The benefits include:

  • Enhanced compliance:

    • Provide real-time guidance and feedback to human operators while they perform tasks or procedures, ensuring that they follow the correct steps and comply with quality standards.
    • Automatically capture and record data during the process, reducing the need for manual documentation and increasing the accuracy and traceability of the records.
  • Improved quality:

    • Help human operators perform tasks more efficiently and effectively and get things right the first time, reducing errors and waste.
    • Facilitate quality control and assurance by enabling operators to use digital tools or simulations to conduct more efficient and thorough inspections of products or equipment.
  • Reduced risk:

    • Help human operators avoid or mitigate potential hazards or risks during the process (for example, exposure to harmful substances or environments) through safety warnings or instructions.
    • Enable remote assistance or collaboration among different teams or experts, reducing the need for physical presence or travel.
  • Increased productivity:

    • Increase the speed and throughput of the process by streamlining workflows and eliminating unnecessary steps or delays.
    • Help human operators learn new skills or update their knowledge more quickly and effectively through interactive training modules or simulations.
  • Enhanced innovation:

    • Foster creativity and innovation by enabling human operators to use digital prototypes or objects to experiment with different scenarios or solutions.
    • Help human operators access relevant information or insights more easily through contextual data or analytics.

By using MR to train or instruct operators at a production line, Guides effectively replaces paper-based approaches. Images, videos, and holographic 3D objects are orchestrated into intuitive, three-dimensional guides that show operators what to do for a task, and where to do it. Therefore, production tasks are completed faster, with fewer errors, and with greater skill retention.

Microsoft Power Platform can be used to set up the required governance for Guides. It also helps you technically scale and manage the life cycle of guides in your enterprise.

The following GxP sections contain articles that introduce relevant considerations and recommendations for using these tools to set up a scalable governance structure. However, because these articles provide general guidance across regulated industries, be sure to familiarize yourself with and follow your industry-specific regulations, regardless of the advice in these articles.

We hope that these articles help make your journey toward eliminating paper-based procedures and increasing efficiency and quality easier to manage.


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