## 2 Literature Review  
### Compliance Management and Regulatory Technology  
Compliance management processes have gained a constantly greater prominence in most business sectors, including, but not limited to, the pharmaceutical, financial services, information security, manufacturing, construction, software, and environmental sectors. Compliance has been defined by [PERSON] (2008) [6], as _\"A desired outcome, with regard to law and regulations, internal policies and procedures, and commitment to stakeholders that can be consistently achieved through managed investment of time and resources. The compliance management includes the legal and tactical activities in day-to-day business processes.\"_ Compliance processes are commonly administered by the governance, risk, and compliance function of companies [7], and can be employed at the design (pre-execution), run (execution), or auditing (post-execution) of a business process [8]. According to [PERSON] (2014) [9], an organization engages in compliance relevant activities with the aim to enforce externally imposed regulations, define and abide to the organization's internal rules and policies and fulfill social requirements stemming from regulatory processes. Moreover, when implemented successfully, compliance management can lead to increased market and investor confidence and business performance [10]. Focusing on the pharma manufacturing industry, regulatory compliance has a dual aim. The first is to ensure that produced medicines are safe and efficient, with the second being the acceleration of the passage of new products through the investigative and regulatory stages of their production [11]. At the same time, it has to be pointed out that compliance management often poses significant challenges to organizations. These result from (i) the large number of stakeholders interested in the associated processes, such as compliance professionals, business partners, customers, and regulatory bodies, and (ii) the frequently changing compliance requirements alongside the variety of their authors and the lack of a shared understanding of the relevant concepts [7; 12]. The manual and paper-based management of compliance is often a very difficult, and costly task that can be susceptible to errors due to its complexity and the repeatedly changing regulations in most industries. As a result of these problems, in recent years several academic and commercial information technology systems have been reported in literature, which aim to automate the support for regulatory compliance. On several occasions, such systems have been denoted as belonging to a specific information technology stream, labeled as regulatory technology (RegTech). [PERSON] and [PERSON] (2019) investigated RegTech in the financial services sector and provided a definition of the term, which can be extended in other industries as well [13]. They defined RegTech as \"_information technology (IT) that (a) helps firms manage regulatory requirements and compliance imperatives by identifying the impacts of regulatory provisions on business models, products and services, functional activities, policies, operational procedures, and controls; (b) enables compliant business systems and data; (c) helps control and manage regulatory, financial and non-financial risks; and (d) performs regulatory compliance reporting._\" They also indicated that RegTech can be used (i) to facilitate reporting compliance, (ii) for the better matching of the actual regulatory requirements with their interpretation and implementation within a company, (iii) to provide for the more efficient and faster detection of regulatory breaches, and (iv) for more efficient delivery of the compliance processes. The complexity of regulatory compliance and the frequently changing requirements pose challenges not only to compliance management but also to RegTech. [PERSON] and [PERSON] (2019) [13], and [PERSON] (2017) [14], in their research work on RegTech for financial services, identified two major perils.