Remote Versus On-Site

The 2019/2020 period has been unique for the Medical Device Industry around the world. This has led companies to seek innovative methods to continue operating, whilst maintaining the safety of their staff and customers. One such change in practice has been the method of performing Validations on site. With strict measures in place preventing access to clean rooms, the factory floor and sites in general, Validation Engineers have had to rely on performing validation executions remotely on equipment in order to continue production.

Video call platforms such as Microsoft Teams or Zoom are being utilised throughout companies, as opposed to in person meetings. During equipment executions, with the assistance of the System Owner on-site, the Validation Engineer is capable of executing a range of protocols such as IQ, OQ, PQ remotely, by observing the System Owner over video call. A benefit to this new approach is improved communication. A Validation Engineer and System Owner working in conjunction with each other can improve the execution of protocols. Opportunities for Continuous Improvement are more likely with these two departments working together.

Software Validations – Remote Testing

For Software Validations, the Validation Engineer is able to remote into the system from their desktop and perform the validation. This also allows the Validation Engineer to observe any changes being made to equipment software by the System Owner during executions. With the creation of test environments, this removes the need to test physically in the clean room. With a lot of new systems, an Operational Qualification (OQ) can be performed in a test environment – at Dataworks we can create this test environment and then perform any required testing.

Benefits of Remote Testing:

1. Improved Time Management

Obtaining access to the location of the machine to complete the validation can take time. Training is required when entering the facility and procedures must be followed when entering clean rooms, including gowning up, Covid-19 awareness and general site training.

Time can be saved by performing the validation remotely, this time can be used by the Validation Engineer to execute protocols, write test scripts, etc. In general, the System Owner will have access to the equipment and be on site, speeding up the process and having a smoother execution. This will result in a larger number of projects being completed and a reduction in the likelihood of human error.

2. Reduced Cost

Not only can time can be saved by performing the validation remotely, but by removing the need for some of the training that is unnecessary when testing remotely. The need to travel and related expenses, can also be saved.

3. Knowledge Sharing

When the Validation Engineer is able to remote into the system this gives them the opportunity to observe any changes being made to equipment Software by the System Owner during executions. Providing greater visibility to all involved in the project. Continued communication between the Validation Engineer and System Owner can lead to knowledge sharing improving the effectiveness of the individual and the team.

4. Reduced Risk of Contamination

Remote execution also removes the need for extra people on-site and in Clean Rooms, thus reducing footfall and interaction. In the time of Covid-19 this reduces the risk of contamination on site.

Electronic Signatures

During this time, remote testing introduces the use of Electronic Signatures for approving documentation and executing protocols.  The process of obtaining an Electronic Signature through Adobe, or any other platform, reduces waiting time for receiving approvals and with less paperwork, in this time of Covid-19, there is less chance of spreading the virus. There is always a chance of human error when writing signatures and dates. By sending the documentation electronically to be signed removes any error and only relies on the Active Directory ensuring greater compliance.

Our team of experienced Validation Engineers can help you to enable greater efficiencies, improved quality and compliancy within your industry. If you would like to discuss how we can use our experience and expertise to deliver real benefits to your business, please Contact Us today or call us on 051 878555.

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