An ontological framework for automated regulatory compliance in pharmaceutical manufacturing

Sesen, M. Berkan; Suresh, Pradeep; Bañares‐Alcántara, René; Venkatasubramanian, Venkat

doi:10.1016/j.compchemeng.2009.09.004

Cited by 24 publications

(6 citation statements)

References 13 publications

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“…The extraction and modeling of the regulatory entities are described in our previous work [10] . Likewise, a processontology, OntoReg has been used, which was created by the Engineering Science Department in the University of Oxford [11]. In OntoReg, a validation-task (Task) is the smallest unit of an organizational process, which can be used for compliance checking.…”

Section: The Rp-match Frameworkmentioning

confidence: 99%

RP-Match: A Framework for Automatic Mapping of Regulations with Organizational Processes

Sapkota

Aldea

Younas

et al. 2013

2013 IEEE 10th International Conference on E-Business Engineering

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Mapping organizational processes with applicable regulatory guidelines is an important step in Regulatory Compliance Management. The Automation of the mapping process can help the overall compliance process. Though existing approaches compute mapping between different entities (e.g., ontology mapping, sentence similarity, semantic similarity and regulation-requirement mapping), the automation of the mapping process between regulation and processes has not been fully investigated yet. In this paper, we present RP-Match framework and propose a cascading-priority algorithm in order to compute similarity between regulation and processes. The framework also takes account of the structures of the regulation ontology and organizational process ontology for the similarity measures. The framework is tested using a Pharmaceutical industry case study. Results obtained show significant improvement in the mapping process.

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Section: The Rp-match Frameworkmentioning

confidence: 99%

RP-Match: A Framework for Automatic Mapping of Regulations with Organizational Processes

Sapkota

Aldea

Younas

et al. 2013

2013 IEEE 10th International Conference on E-Business Engineering

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“…An ontological approach to regulatory compliance through automated process validation was presented in Sesen et al, 17 based on work by the author and collaborators. The prototype implementation, OntoREG, encapsulates pharmaceutical process and regulation knowledge within two complementary representations:…”

Section: Integrating Ontomodel With a Pharmaceutical Process Validati...mentioning

confidence: 99%

“…19 The overall interactions between the various tools used in this approach are shown in Figure 21. 17 In this section, one of the case studies that is discussed, which concerns the investigation of the reaction yield associated with the aspirin manufacturing process, will be extended to show integration with OntoMODEL. This will demonstrate that OntoMODEL is multifaceted in terms of its applicability and that its uses are far reaching.…”

Section: Integrating Ontomodel With a Pharmaceutical Process Validati...mentioning

confidence: 99%

“…OntoREG has been validated using a case study from the aspirin production process in the context of its compliance with some equipment maintenance and cleaning regulations extracted from the European Union Guidance on Good Manufacturing Practice . The overall interactions between the various tools used in this approach are shown in Figure …”

Section: Integrating Ontomodel With a Pharmaceutical Process Validati...mentioning

confidence: 99%

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OntoMODEL: Ontological Mathematical Modeling Knowledge Management in Pharmaceutical Product Development, 2: Applications

Suresh

Hsu

Reklaitis

et al. 2010

Ind. Eng. Chem. Res.

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The challenges of managing the information and knowledge involved in pharmaceutical product development in a systematic and reusable, yet user-friendly, manner are very real and substantive. The benefits of managing the mathematical knowledge component in this can, by itself, lead to significant monetary and time savings, because of the reduced cost of interoperability. In the first part of this series, an ontological approachsnamely, the OntoMODEL conceptual framework that addresses this needshas been presented. In this paper, applications of this framework are described, which involve the use of OntoMODEL as an integrated component of model-based decision support processes in the domain of model predictive control, in decision making associated with drug formulation and in drug process validation. OntoMODEL is shown to provide an easy and intuitive approach to analyze controller performance, which allows the user to experiment with various controller configurations with minimum effort. OntoMODEL can also effectively support the multilevel product formulation process involving both experimental results and evaluation of model-based performance indices. Finally, aspects of regulatory compliance that involve evaluation of models are also well-supported. This paper demonstrates that OntoMODEL can effectively serve as the multifunctional platform for mathematical model-based applications in the domain of chemical and pharmaceutical process and product development.

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“…In industry, automated compliance information systems are regularly used to maintain point‐source water quality standards. Organizations increasingly employ commercially available Governance, Risk, and Compliance (GRC) software to automate required sampling, product monitoring, and to produce compliance validation documentation (Sesen et al 2010; Butler and McGovern 2012; Papazafeiropoulou and Spanaki 2016). GRC software has grown to a multibillion‐dollar industry, including applications in environmental regulation (Bamberger 2009).…”

Section: Introductionmentioning

confidence: 99%

Enhancing Efficacy of Water Quality Trading with Automation: A Case Study in Virginia’s Nutrient Trading Program

Saby

Goodall

Band

et al. 2021

J American Water Resour Assoc

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The complexity of water quality trading (WQT) policy can lead to the promulgation of regulations that are challenging to comply with and to enforce. As a result, transaction costs may be high and administrators have limited ability to monitor the program outcomes. These concerns can be alleviated in part through increased automation of trading compliance procedures. We present a case study of a pilot system designed for the Virginia Department of Transportation that automates compliance and streamlines brokering processes that are a part of the Virginia nonpoint source WQT program. Outcomes of this work reveal opportunities and challenges for implementing automated systems in WQT and suggest a framework for developing automated programs. We conclude that use of automated procedures to facilitate compliance with WQT rules can help identify gaps in data reporting and availability, amend inconsistency in rule interpretation, and reduce transaction costs for credit purchasers by enabling efficient analysis of trading opportunities. Persistent limitations to automation exist, including lack of standardized, machine accessible, and open data sources. Potential long‐term benefits of automating WQT processes include minimizing transaction costs, enabling new environmental data collection and policy analysis, and ultimately yielding improved WQT program efficacy and water resources outcomes.

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An ontological framework for automated regulatory compliance in pharmaceutical manufacturing

Cited by 24 publications

References 13 publications

RP-Match: A Framework for Automatic Mapping of Regulations with Organizational Processes

RP-Match: A Framework for Automatic Mapping of Regulations with Organizational Processes

OntoMODEL: Ontological Mathematical Modeling Knowledge Management in Pharmaceutical Product Development, 2: Applications

Enhancing Efficacy of Water Quality Trading with Automation: A Case Study in Virginia’s Nutrient Trading Program

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