Audit Syngene Virtually

Introduction

The COVID-19 pandemic has changed the way we do business. It has forced organizations to adapt to the new normal of no travel, remote working and virtual meetings – even while ensuring business as usual.

Technology has played a key role in making this shift including in the field of audits. Leading the way in this space is Syngene. With several virtual audits to its credit, Syngene is enabling clients experience its capability and infrastructure, regardless of barriers of distance and time.

Virtual audit makes use of Information and Communication Technologies (ICT) to audit sites and people virtually, when a physical visit is not possible. Here, you can communicate, share, review and access systems without the need for the client or auditor to be physically present at the site where the activities subject to inspection would routinely be hosted.

Virtual audit is expected to continue even beyond COVID-19. Not surprising, given its advantages of costs and convenience, without compromising on the 360 degree experience of an actual physical visit.

The possibilities are limitless. It is for you to explore and choose what works best for you.

How to Conduct a Virtual Audit for Pharma Quality Assurance

  • A successful virtual audit relies on adequate connectivity (i.e. voice and video) to ensure the communication between you and the service provider is stable.
  • Once your connection is up and running, you can collect audit evidence by way of: o Interview o Review of documentation and records (via screen sharing) and upload in shared folders/repository o Observation of processes and activities (via video sharing and walkthroughs)

Virtual Audit for Audit Readiness and Pre-Inspection Planning

Virtual audits can become a powerful tool from a client perspective. This is because it gives you more time to design the approach you would like to take before the audit, as well as plan the types of requests you would like to make during the audit. This pre-audit planning would help you see things in the right perspective – both in terms of the facilities available, and the manner in which the services are delivered.

Virtual Audit vs Physical Audit: Benefits for Remote Inspection

Comparison table showing differences between physical audits and virtual audits in terms of logistics, document sharing, facility walkthroughs, reporting, and CAPA implementation

Planning a Virtual Audit: Steps to Ensure Compliance Transparency

Checklist for planning a virtual audit highlighting key personnel availability, document preparation, reliable connectivity, and confidentiality and data protection requirements

Syngene’s Virtual Audit Process for Remote GMP Inspection

Step-by-step workflow of a virtual audit process, from planning and scheduling to conducting the audit remotely, addressing non-conformities, and receiving certification

Technologies Enabling Virtual Audit and Remote Inspection in Pharma

Syngene has invested in high-end technologies to make your virtual experience as close to reality as possible. These include tools for conducting virtual audit in real-time and in on-demand mode.

Remote Eye: Augmented Reality (AR) Technology for Virtual Audit in Pharma

To make your virtual experience as close to reality as possible, Syngene uses the Remote Eye application. Syngene can deploy this application on smartphones, tablets, and smart glasses to enable remote viewing in real-time. At Syngene, the Remote Eye software is on an industrial-grade Tablet carried by a Syngene representative taking you on your guided tour. All you need to do, is click on the Remote Eye meeting link shared by the Syngene team, and join the video call with your guide from your laptop, mobile or Tablet. As the representative moves around the facility, with the Tablet in hand, you will be able to view his/her surroundings in real-time. You can ask the guide questions, ask to move closer to the object you want to see, zoom out, or point the Tablet to a specific location – all in real-time. Syngene uses Fire Hawk, an 8-inch industrial tablet with an IP65 rating for virtual audit purposes. The Tablet is designed to work in extreme environmental conditions and can withstand rough handling.

Insta Visit: Your Interactive Virtual Experience

Syngene InstaVisit is an interactive virtual experience designed to give you a 360 degree view of Syngene’s world-class facilities and capabilities, on-demand. Based on pre-recorded video footage of our facilities, the platform allows you to change your perspective, look around, zoom-in/out as you are taken on a guided tour of Syngene’s labs. Clients/Auditors can have a look around the facility including labs associated with each Operating Unit through this platform.

Syngene’s Track Record in Virtual Audit and Audit Readiness

Table listing virtual audits conducted, including customer name, audited department (GLP, GMP, GCP), and audit dates
Extended table showing additional virtual audits conducted for global biopharmaceutical, vaccine, CRO, and pharmaceutical companies, including audited departments and audit dates
Table listing additional virtual audits conducted for global pharmaceutical, biotech, and healthcare companies, detailing audited departments such as GMP, GLP, and GCP, along with audit dates
Extended table showing additional virtual audits conducted for global biopharmaceutical, vaccine, CRO, and pharmaceutical companies, including audited departments and audit dates

Putting Science to Work Starts Here

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