Watch the Recording: "Blueprint for SOP Success: Unlocking the Power of Cloud-based Environmental Monitoring"

Missed the live session? You can still gain valuable insights from our recently completed webinar, presented by Antoine Nguyen, Vice President of GxP and Compliance at Dickson. In this recording, you'll discover how cloud-based environmental monitoring can transform operations in highly regulated industries, helping you manage Standard Operating Procedures (SOPs) for compliance and ensure regulatory readiness.

What You'll Learn:

  • Regulatory Requirements: Gain a deep understanding of critical regulatory standards and how they impact your operations.
  • Aligning SOPs with Cloud Monitoring: Learn how integrating cloud-based monitoring solutions can streamline SOP management and enhance compliance.
  • Demonstration of DicksonOne: Watch a comprehensive demo of the DicksonOne platform and see how it can revolutionize your environmental monitoring processes.
  • Expert Q&A: Hear answers to key questions from our interactive Q&A session with industry experts.

Who Should Watch:

  • Quality Assurance Managers
  • Compliance Officers
  • Laboratory Managers
  • Pharmaceutical Professionals
  • Operations Managers
  • Research and Development Scientists
  • Facility Managers

Why Watch?

In a rapidly evolving regulatory landscape, staying ahead of compliance requirements is more important than ever. This webinar recording offers invaluable insights into SOP management through advanced cloud-based environmental monitoring solutions. Don’t miss out on the opportunity to unlock the full potential of your compliance strategy and gain a competitive edge.

Watch the recording now and elevate your compliance strategy!

 Antoine-T10

Presented by Antoine Nguyen, VP GxP and Compliance

 

Q&A Summary:

Here are the detailed questions and answers from the Q&A section of the webinar:

  1. Scalability Challenges:

    • Question: What are some of the challenges you see when scaling SOPs across multiple locations?
    • Answer: The common challenges include maintaining consistent communication of operating parameters and enforcing SOPs across different sites. Using a centralized system like DicksonOne helps apply these parameters uniformly across all locations, ensuring compliance and reducing manual errors. Additionally, having a centralized system simplifies the task of maintaining compliance across different locations, making it easier to ensure that all sites adhere to the same standards .

  2. Data Integrity Considerations:

    • Question: What specific considerations related to data integrity should be made when transitioning from a manual process to a validated system?
    • Answer: In GXP environments, considerations around data integrity include ensuring security and access control, maintaining uneditable audit trails, and reducing human errors by automating processes. DicksonOne tracks user interactions and system changes, ensuring that all data is accurate and compliant with FDA's part 11 requirements, which are crucial for maintaining data integrity in regulated environments .

  3. Scaling SOPs Across Multiple Locations:

    • Question: What should be considered when expanding SOPs to new or existing locations?
    • Answer: Successful scaling often involves central responsibility, where knowledge and expertise from the initial location are leveraged when implementing SOPs at new sites. Consistency in following and implementing SOPs across all locations is crucial. Centralized systems can help maintain these standards across multiple sites. It’s important that the SOPs implemented at the first location are followed and applied similarly at additional locations to ensure consistency .

  4. Managing Alarms Across Multiple Locations:

    • Question: How can alarms be effectively managed across multiple locations?
    • Answer: Alarm templates allow organizations to set predefined thresholds for various environmental parameters, ensuring consistency across all devices and locations. This reduces the risk of human error and helps maintain compliance with regulatory bodies. The use of centralized monitoring systems like DicksonOne enables easy management of alarms and responses across multiple sites, ensuring uniformity and compliance across the organization .

  5. Considerations for Thermal Mapping:

    • Question: What specific considerations should be taken into account when conducting thermal mapping in regulated environments?
    • Answer: When conducting thermal mapping, it’s essential to ensure that the mapping is comprehensive and aligns with the regulatory requirements of the specific industry. This includes considering the uniformity of temperature distribution within storage or transport areas, especially in environments like pharmaceutical storage. Additionally, it’s important to document and validate the process thoroughly to ensure that it meets industry standards and can withstand regulatory scrutiny .