PDA Letter Article

PDA in Print: Planning for Effective Use of Technology for Remote Inspections

by PDA, Inc.

[Editor’s Note: The following has been excerpted from PDA’s Points to Consider in Remote and Hybrid GMP/GDP Inspections.]

In selecting technology for a virtual inspection, two points are important to keep in mind:

  • Technology Overkill: Technology is intended to help the successful execution of the inspection, not to showcase different options. Companies being inspected may range from large, well-resourced global companies to smaller organizations in remote locations with less-developed infrastructure. Balance should be maintained in technology options.
  • Technology Exploration: Exploring new technologies or options during the inspection is not recommended, as these options may require installation and training time or may unnecessarily delay the inspection.

Because many factors can impact the actual performance of the technological tools during a virtual inspection, all technology must be tested in advance, including the document-sharing platform, video communication platform, and Wi-Fi network (for robustness). The connectivity of the devices to be used also should be tested in all areas of the site and remote locations. Each participant should have a reliable internet connection of a speed that matches the requirements of the video communication platform, to allow for consistent and stable audio and video. A half-hour real-time test several days before the inspection can be helpful to check for and resolve any issues, including any limitations on software use based on geographical region, elapsed time, and number of users.

In discussing the software and applications to be used, the two parties should be sure to identify any known or potential compatibility issues, such as antivirus software, that is known to inhibit the use of certain applications. The inspected site may recommend an internet browser to be used during the inspection, as the site may have the most knowledge of any software compatibility issues relating to specific browsers.

If site personnel will be demonstrating site-specific software during the inspection, they should verify in advance that the software is accessible from the computer system that the personnel will use during the inspection. Software specific to the manufacturing location or laboratory, including software used for issuance of batch records, temperature and pressure monitoring, and other integrated manufacturing software systems, may not be accessible from all company computers or may reside on networks that are decoupled from the internet. Advance preparation will ensure that personnel can participate in the inspection from the manufacturing location or laboratory, or that they can take other necessary steps.

Whether inspectors will be given direct access to data systems also should be discussed early. As covered more fully in Topic II.C.1 Inspector Access to Systems, allowing inspectors direct access to GxP systems is not recommended due to the need for training and the risk of creating errors within the systems. Instead, a site expert can log into the system, share his/her screen through the video communication platform so the inspector has a clear view of the data and information, and allow the inspector to direct the expert’s movements through the system.

Click here to purchase PDA’s Points to Consider in Remote and Hybrid GMP/GDP Inspections.