What is Virtual Factory Acceptance Test?

The vFAT is based on a virtual way of conducting tests for the equipment/system at the vendor site. Simply, where the customer can avoid travelling thousands of kilometres thus save travel time to watch their live running machines. With Virtual FAT, the client can watch the tube or closure running of the equipment/system. They can inspect the critical parts of the live running machines and can discuss important things with the vendor from wherever he, she, or they may like.

Conducting of Virtual FAT OEM uses multiple high-quality cameras to give the best possible view of the machine. One camera is placed to view the entire area. Other cameras are placed around the device to see specific details. The control panel can be watched live with the movable camera to get the result, data, performance and functioning of the machine. The manufacturers are flexible to move each camera according to the customer’s needs or specific requests.

Requirements for the online meeting tools:

High-speed internet connects plays a vital role for vFAT, the other requirement like a laptop, a computer, a tablet, or a mobile phone equipped with a microphone and speaker. The headset gives better audio quality than using portable speakers. There is no requirement for any specific software. However, some vendors take the support of online tools like WebEx, Zoom, Google Meet and Microsoft teams. The meeting is conducted by sharing a link of these online tools by the manufacturer.

Document Handling:

Vendor should have a controlled copy of the FAT issued via Document Control or by SCAN copies after approval by the site QA team.

Lastly, a signature log of the vendor and site team to witness their presence physically equipped to execute the FAT (live video play-back, handheld cameras and daily log sheet etc.)

Timelines:

Before this pandemic, the timelines for conducting onsite FAT can be pre-planned and fixed by the FAT team.  But in current situation, timelines gets exceeded due to virtual FAT, which takes place virtually. Time-consuming happens from both the vendor and the site team. It can take 2-3 hours a day to set-up the live streaming and ensure that both the audio and visual parts are working correctly and all online documents are verified.

Cost and Expenditure:

As the site team conducts FAT from their premises, the client saves the high travel and accommodation expenses. The client also saves the travel time of the team, which can be a week or more? Generation of a document, time, internet connections, and accessories can cost a bit from both vendor and project team.

Due to virtual FAT, purchase order needs to be balanced from both manufacturer and site team, which is different from the original project scope (Initial costings may differ).

Using Virtual Smart Glasses (Optional)

The on-site manufacturer can use the Virtual Smart Glasses, these glasses make the instructor hands-free while moving around the environment and projecting their view of instruments, equipment, and more to the rest of the team. This type of platform is also interactive, this allows the instructor to see and talk with all participants and also help to pull documents into smart glasses, while still seeing their environment and making the smooth operation for Virtual Factory Acceptance Test.

Virtual Machine Training & Trouble Shooting:

It is vital to train the operator. Hence live virtual machine training with training modules and multiple training sessions is mandatory for the smooth operation of the machine. There should be a service team that can perform troubleshooting with virtual access to resolve the issues and give smooth function of equipment.

What do Pharma companies is expected to do in line with OEM for Conducting Virtual FAT:

All this virtual/Virtual FAT Protocols are to be pre-approved by quality assurance team, and detailed plan to be made for smooth functioning, so that the presence of QA for witnessing the “real time” FAT. In order to make this, change control to be raised along with risk assessment, detailing the procedure and risks involved while conducting the Virtual FAT.

Standard operating Procedures should be in place for Virtual FAT:

The quality Assurance team shall have a Quality Vendor Audit/Review of QMS for conducting Virtual FAT Procedures of Vendors. Assessment of vendor training on the Project pre-requisites procedures (FAT Plan, Punch list Plan, GDP Plan) by QA team.

Initial Training:

The site team is not trained or experienced with the Virtual FAT. Hence before beginning Virtual FAT, OEM will conduct initial training with the site team concern to the accessories and tools while handling. Training aspects should include technical capabilities, safety systems, IT systems, hardware and software to be used.

Daily Punch list:

The punch listing for Onsite FAT and Virtual FAT will remain the same. The OEMs and the project team should follow the same approved procedure.

Project Review:

A close review of project documents is required with the vendors to ensure a smooth Virtual FAT. Instead of dragging many things concern to purchase order, a close working relationship will help us for good and smooth functioning of Virtual FAT. Vendors should also have a continuous connection with the purchasing team needed with all mails or with telephonic discussions. Every minute of meetings for all talks are to be shared. The same has to be noted and documented.

What can be done for the FAT proofs?

On request, while performing the Virtual FAT the same can be recorded by both, client and the vendor, on completion, the digital recorded clips can be shared with each other to maintain the records. This will benefit both the parties in case of any disputes arise in future.

Limitations of Virtual FAT:

• Controls exist with the testing engineer.
• Internet connectivity between On-site test engineers and receiver site.
• Communication gap between engineer and receiver due to language barrier.
• Finally with time zone between different countries.

What will be missed in the Virtual FAT Apart from GMP?

At the maximum point, there will be the same experience in Virtual FAT as that of On-site FAT, like a live machine in action. What will we miss? At the most, there is a lack of interaction between experts from both the end, travelling to the workshop, onsite hospitality, personal meet and greet.