The pharmaceutical industry is one of the most regulated sectors in the world, and for a good reason. The safety and efficacy of the drugs that millions rely on depend on adherence to strict quality standards and regulations. These standards and regulations are known as GxP (Good Practice) protocols. They cover every aspect of the drug development and manufacturing process, from research and development to clinical trials to distribution and post-marketing surveillance.
However, complying with Good {industry} Practice (GxP) protocols is not an easy task. It requires resources, expertise, training, and coordination among different teams and departments. It also poses significant challenges regarding efficiency, productivity, innovation, and competitiveness. For example, some of the common issues that pharma manufacturers face when following GxP protocols are:
- Human errors and inconsistencies: Even with rigorous training and supervision, human operators can make mistakes or forget some steps or procedures when performing complex or repetitive tasks. These errors can compromise the quality of the products or lead to costly rework or recalls.
- Lack of visibility and collaboration: Due to the high level of specialization and compartmentalization of the different functions and roles involved, more communication and collaboration are often needed among other teams and departments. The lack of visibility can result in delays, misunderstandings, conflicts, or missed opportunities for improvement.
- Inflexibility and inefficiency: Due to the strict requirements and regulations, pharma manufacturers often must follow rigid and standardized workflows and processes that may only be optimal for some situations or products. The workflows can limit their ability to adapt to changing customer needs, market demands, or technological innovations.
Microsoft announces the availability of guidelines for utilizing Dynamics 365 Guides in GxP regulated industries.
This comprehensive guide provides best practices and recommendations for using Guides in GxP environments. It covers topics such as:
- How to plan, design, develop, test, deploy, and maintain Guides for GxP processes
- How to validate Guides for GxP compliance
- How to train and support users of Guides
- What to think about and how to set up governance to support Guides.
The GxP guide highlights the experience and feedback of several GxP-regulated companies that have successfully implemented Guides in their operations. It also incorporates the latest industry standards and regulatory requirements for GxP systems.
Customers can leverage the power of Mixed Reality (MR) technology combined with Dynamics 365 Guides to address the challenges. MR encompasses both Augmented Reality (AR) and Virtual Reality (VR) to create immersive and interactive experiences with digital overlays on the physical world or a simulated environment. Guides gives you a digital representation of your instruction in the overlay. MR can offer benefits for pharma manufacturers who need to comply with GxP protocols, such as:
- Enhanced compliance: Provide real-time guidance and feedback to human operators during the execution of tasks or procedures, ensuring that they follow the correct steps and comply with the quality standards. Capture and record data automatically during the process, reducing the need for manual documentation and increasing the accuracy and traceability of the records.
- Improved quality: Enable human operators to perform tasks more efficiently and effectively, reducing errors and waste, getting it right the first time is essential. Facilitate quality control and assurance by allowing operators to inspect products or equipment more efficiently and thoroughly using digital tools or simulations.
- Reduced risk: Help human operators to avoid or mitigate potential hazards or risks during the process, such as exposure to harmful substances or environments, with safety warnings or instructions.
- Increased productivity: Increase the speed and throughput of the process by streamlining workflows and eliminating unnecessary steps or delays. Enable human operators to learn new skills or update their knowledge more quickly and effectively using interactive training modules or simulations.
- Enhanced innovation: Foster creativity and innovation by allowing human operators to experiment with different scenarios or solutions using digital prototypes or models. Enable human operators to access relevant information or insights more easily using contextual data or analytics.
- Minimise cost: Enable remote assistance or collaboration among different teams or experts, reducing the need for physical presence or travel for maintenance or specialist help.
Microsoft's Dynamics 365 Guides with HoloLens 2 is the leading Mixed Reality application used by above companies that can help pharmaceutical manufacturers achieve these benefits. Examples and solutions from other industries:
- Train frontline workers, also in safe environments and remotely – leading to reduced training time by 70% (Suntory), and yearly savings of 300k€ and 80% CO2 emissions on reduced travel (Renault Group)
- Provide on-the-job instructions during execution of complex tasks and Standard Operating Procedures – helping reduce assembly and maintenance time by 90% (Toyota), and improve “first time right” quality with 0 errors in 3 years (Lockheed Martin)
- Consult remote experts for eg maintenance and troubleshooting – leading to 50% faster issue resolution (L’Oréal), and 90% reduced downtime (Faurecia)
- Inspect remotely for eg design reviews, quality, and factory audits – reducing design validation time by 80% (Airbus), and shift 50% of field technicians’ inspections to virtual
- Provide asset insights via IoT and Digital Twins, towards Industrial Metaverse – to reduce eg energy consumption by 9% and CO2 by 70 tons (Coca-Cola HBC Austria)
Dynamics 365 Guides is a HoloLens 2 application that allows users to create step-by-step instructions using holograms that guide them through tasks or procedures in their physical environment. Customers can use Dynamics 365 Guides for various purposes: training, troubleshooting, maintenance, assembly, inspection, verification, and validation.
Dynamics 365 Guides can help pharmaceutical manufacturers comply with GxP protocols by providing them with a powerful tool to create, deliver, monitor, and improve their processes in a consistent, standardized, and scalable way. Dynamics 365 Guides can also integrate with other Microsoft solutions, such as Dynamics 365 Remote Assist, Power Apps, Power Automate, Power BI, and Azure IoT Hub, to enable seamless data flow and collaboration across different platforms and devices.
Microsoft has been working closely with several pharmaceutical manufacturing companies adopting Dynamics 365 Guides. These companies have experienced tremendous success with Dynamics 365 Guides in terms of improving compliance, efficiency, productivity, and cost:
- Novo Nordisk uses Guides to support their productivity in their biopharma manufacturing. Changing how they create instructions and dramatically reducing the time spent on paper-based procedures, now using augmented instructions.
- AstraZeneca: HoloLens technology enables scientists to use augmented reality to see their lab protocols and recent actions, helping them keep track of their experiments and save time.
The guidelines for GxP regulated industries are available on the Microsoft Dynamics 365 Guides documentation website. It is a valuable resource for any GxP company that wants to leverage the power of Mixed Reality to achieve quality and compliance goals. If you want to learn more about how Dynamics 365 Guides can transform your business, visit https://dynamics.microsoft.com/en-us/mixed-reality/guides/capabilities/
