![]() ![]() The individual bots are GAMP® Category 1 software components. They can then be instructed to perform specific business processes (GxP or non-GxP) as required by means of specific automations or scripts. The bots will be set up (or qualified) as general infrastructure components that are ready to use with some general account, access control, and security settings. This list of example platforms and products is included for convenience only and should not be regarded as complete or definitive. Examples of platforms or products characterized as robotic process automation include, but are not limited to, Automation Anywhere, Blue Prism, EdgeVerve, HelpSystems, UiPath, Workfusion, Kofax, NICE, PegaWorld, and Kryon. The underlying package or product is classified as GAMP® Category 1 software. ![]() Robotic process automation technology consists of the following main components: the underlying package or product, the individual bots, and the automation or script (see Figure 1). ![]() Therefore, their use should be carefully planned and controlled. It takes little or no previous experience to program bots, and separate application bots may not change the underlying systems however, robotic process automation bots can influence the business process and related data. Rather, it is sometimes regarded as sitting on top of that architecture, with robotic process automation software implementation and operation being possible without changing the existing systems. Robotic process automation software is not always considered part of an organization’s traditional IT systems architecture. Other types of bots are knowbots, which search the internet to gather specific information, and chatbots, which respond to human input or queries in real time. This article focuses on probots-bots that follow simple, repeatable rules to process data. Robotic process automation technologies can be divided into three types: probots, knowbots, and chatbots. Robotic process automation bots can log into applications, extract data, enter data, complete tasks, and log out. This may be likened to recording an action and then programming the bot to replay it. robotic process automation simulates how a human user would use an application’s graphical user interfaces (GUIs) to perform tasks, which the bot performs by automatically executing those tasks directly in the graphical user interface without human intervention. Robotic process automation technology uses software bots to mimic the activities of human workers. Robotic process automation is a technology application that allows the configuration of computer software (a robot or “bot”) to capture and interpret data from existing applications for processing transactions, manipulating data, triggering responses, and communicating with other computerized systems. The approach described here is consistent with GAMP® 5 and has undergone GAMP® subject matter expert (SME) review. It is, however, the intent of the GAMP® Special Interest Group (SIG) to continue to actively consider these topics and how these approaches may be applied together. We focus on deterministic robotic process automation and do not discuss related but significantly different approaches, such as artificial intelligence (AI), machine learning (ML), or cognitive automation (CA). ![]()
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