Relevant bibliographies by topics / And Approaches of Process Validation

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'And Approaches of Process Validation'

Author: Grafiati
Published: 2 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "And Approaches of Process Validation"

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Richa Shukla, Dr. Nimita Manocha, and Dr. Gurmeet Singh Chhabra. "Theoretical Approaches to Process Validation in Pharmaceutical Manufacturing Process." International Journal of Scientific Research in Science and Technology 11, no. 2 (2024): 573–85. http://dx.doi.org/10.32628/ijsrst52411229.

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Under the more general statutory CGMP provisions of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act, validation of manufacturing processes is deemed a legal part of current good manufacturing practice for active pharmaceutical ingredients (APIs). Validation of manufacturing processes is required by the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR 211.100 and 211.110). A medication should be created that is suitable for its intended purpose, according to the fundamental tenet of quality assurance. Procedure Validation is the collect
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Pratibha, Thapliyal* Neha Sodiyal Shivanand Patil. "A Review on Process Validation of Pharmaceutical Tablet." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4393–401. https://doi.org/10.5281/zenodo.15518879.

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This review aims to outline the effects of effective process validation in the pharmaceutical sector. Pharmaceutical tablets are the solid oral dosage form widely used for the prevention, diagnosis, and mitigation of disease. Process validation refers to the documented proof that a manufacturing process reliably yields a product that meets established specifications and quality attributes. The main objective of process validation is to guarantee that pharmaceutical products are consistently safe, effective, and of superior quality. This process focuses on enhancing the safety and quality of th
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Vaibhav*, Obed Singh Shivanand Patil. "A Review on Process Validation of Ursodeoxycholic Acid Tablets Ip 300 Mg." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3524–31. https://doi.org/10.5281/zenodo.15476783.

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Pharmaceutical Validation is one of the important processes in achieving and maintaining the quality of the final drug product. If each step of the manufacturing/packing process is validated, then we can ensure that the final product is of the best quality. Pharmaceutical Process validation is an essential component for the safety of drug product and to maintain the quality of the product. Validation is establishing documented evidence which provides a high degree of assurance that a specific process for manufacturing tablets will consistently produce a product meeting its pre-determined speci
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L., P. Jain*1 M. S. Charde1 S. J. Momin1 S. V. Potdar2 N. D. Kulkarni1. "Quality by Design in HPTLC: A Review of Method Development Approaches." International Journal of Scientific Research and Technology 2 (June 3, 2025): 179–97. https://doi.org/10.5281/zenodo.15585927.

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A methodical approach to development, Quality by Design (QbD) starts with predetermined goals for a product, process comprehension, and process control based on knowledge and quality risk management. When developing and validating a traditional approach, it is possible that it will not achieve the desired outcome. AQbD is the application of the QbD idea to the validation of analytical  methods. A systematic and trustworthy strategy for developing analytical processes that cover all stages of a product's lifecycle is offered by AQbD.  The AQbD technique for creating the HPTLC method i
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Buranathiti, Thaweepat, Jian Cao, Wei Chen, Lusine Baghdasaryan, and Z. Cedric Xia. "Approaches for Model Validation: Methodology and Illustration on a Sheet Metal Flanging Process." Journal of Manufacturing Science and Engineering 128, no. 2 (2006): 588–97. http://dx.doi.org/10.1115/1.1807852.

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Model validation has become an increasingly important issue in the decision-making process for model development, as numerical simulations have widely demonstrated their benefits in reducing development time and cost. Frequently, the trustworthiness of models is inevitably questioned in this competitive and demanding world. By definition, model validation is a means to systematically establish a level of confidence of models. To demonstrate the processes of model validation for simulation-based models, a sheet metal flanging process is used as an example with the objective that is to predict t
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Choi, Wansuk, and Seoyoon Heo. "Deep Learning Approaches to Automated Video Classification of Upper Limb Tension Test." Healthcare 9, no. 11 (2021): 1579. http://dx.doi.org/10.3390/healthcare9111579.

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The purpose of this study was to classify ULTT videos through transfer learning with pre-trained deep learning models and compare the performance of the models. We conducted transfer learning by combining a pre-trained convolution neural network (CNN) model into a Python-produced deep learning process. Videos were processed on YouTube and 103,116 frames converted from video clips were analyzed. In the modeling implementation, the process of importing the required modules, performing the necessary data preprocessing for training, defining the model, compiling, model creation, and model fit were
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Yung, S. K., and D. W. Clarke. "Local Sensor Validation." Measurement and Control 22, no. 5 (1989): 132–41. http://dx.doi.org/10.1177/002029408902200502.

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Current approaches to plant fault detection require an overall process model. This paper argues that a hierarchical scheme is more efficient in which the lowest level concentrates on validating the signals transmitted by individual sensors. Signals are described in terms of standard time-series models. A fault is defined by the signal's deviation from its expected behaviour and various signal processing techniques are described which detect these aberrations.
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Spring, Gary S. "Critical Review of Expert System Validation in Transportation." Transportation Research Record: Journal of the Transportation Research Board 1588, no. 1 (1997): 104–9. http://dx.doi.org/10.3141/1588-13.

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Expert system validation—that is, testing systems to ascertain whether they achieve acceptable performance levels—has with few exceptions been ad hoc, informal, and of dubious value. Very few efforts have been made in this regard in the transportation area. A discussion of the major issues involved in validating expert systems is provided, as is a review of the work that has been done in this area. The review includes a definition of validation within the context of the overall evaluation process, descriptions and critiques of several approaches to validation, and descriptions of guidelines th
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Pimenov, Denis, Alexander Solovyov, Nursultan Askarbekuly, and Manuel Mazzara. "Data-Driven Approaches to User Interface Design: A Case Study." Journal of Physics: Conference Series 2134, no. 1 (2021): 012020. http://dx.doi.org/10.1088/1742-6596/2134/1/012020.

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Abstract The most common reason for software product failure is misunderstanding user needs. Analysing and validating user needs before developing a product can allow to prevent such failures. This paper investigates several data-driven techniques for user research and product design through prototyping, customer validation, and usability testing. The authors implemented a case study software product using the proposed techniques, and analyses how the application of UX/UI research techniques affected the development process. The case study results indicate that preliminary UX/UI research befor
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Rajamanickam, Vignesh, Heiko Babel, Liliana Montano-Herrera, et al. "About Model Validation in Bioprocessing." Processes 9, no. 6 (2021): 961. http://dx.doi.org/10.3390/pr9060961.

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In bioprocess engineering the Qualtiy by Design (QbD) initiative encourages the use of models to define design spaces. However, clear guidelines on how models for QbD are validated are still missing. In this review we provide a comprehensive overview of the validation methods, mathematical approaches, and metrics currently applied in bioprocess modeling. The methods cover analytics for data used for modeling, model training and selection, measures for predictiveness, and model uncertainties. We point out the general issues in model validation and calibration for different types of models and p
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Dissertations / Theses on the topic "And Approaches of Process Validation"

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Allan, Alastair Ian Charles Grant. "EFL reading test validation : investigating aspects of process approaches." Thesis, Lancaster University, 1992. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.333880.

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Cascone, Giovanni. "Modeling salami drying with different approaches and validation during industrial ripening." Doctoral thesis, Universita degli studi di Salerno, 2018. http://hdl.handle.net/10556/3053.

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2016 - 2017<br>Nowadays, ripening of salami under natural conditions has been replaced by batch production in ventilated industrial chambers. Hence, the same product quality can be obtained regardless of local, environmental and climatic conditions. Nevertheless, carefully designed and monitored process conditions are necessary to achieve the targeted weight loss and quality of dry fermented sausages. Therefore, the availability of reliable mathematical models and manageable software codes for sausage drying, maturation and optimal production are highly welcome. This thesis deals with the dev
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Wang, Yan. "An integrative process mining approach to mine discrete event simulation model from event data." Thesis, Bordeaux, 2018. http://www.theses.fr/2018BORD0183/document.

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L'inférence d’un système, par la reconstruction de la structure à partir de l’analyse de son comportement, est reconnue comme un problème critique. Dans la théorie des systèmes, la structure et le comportement se situent aux extrémités de la hiérarchie qui définit la connaissance du système. L'inférence d’un système peut être également considérée comme l’escalade de la hiérarchie depuis la connaissance de bas niveau vers la connaissance de plus haut niveau. Ceci n'est possible que sous des conditions maitrisées et justifiées. Dans cette thèse, une nouvelle méthode d'inférence de système est pr
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Cardamone, Salvatore. "An interacting quantum atoms approach to constructing a conformationally dependent biomolecular force field by Gaussian process regression : potential energy surface sampling and validation." Thesis, University of Manchester, 2017. https://www.research.manchester.ac.uk/portal/en/theses/an-interacting-quantum-atoms-approach-to-constructing-a-conformationally-dependent-biomolecular-force-field-by-gaussian-process-regression-potential-energy-surface-sampling-and-validation(508ed450-9033-4bc9-8522-690d5a7909eb).html.

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The energetics of chemical systems are quantum mechanical in origin and dependent upon the internal molecular conformational degrees of freedom. "Classical force field" strategies are inadequate approximations to these energetics owing to a plethora of simplifications- both conceptual and mathematical. These simplifications have been employed to make the in silico modelling of molecular systems computationally tractable, but are also subject to both qualitative and quantitative errors. In spite of these shortcomings, classical force fields have become entrenched as a cornerstone of computation
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Schaefer, Cédric. "A Process Analytical Technology (PAT) approach involving near infrared spectroscopy to control the manufacturing of an active pharmaceutical ingredient : development, validation and implementation." Thesis, Aix-Marseille, 2013. http://www.theses.fr/2013AIXM4375.

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Les entreprises pharmaceutiques ont progressivement adopté le concept de Process Analytical Technology (PAT) afin de contrôler et d'assurer en temps réel la qualité des produits pharmaceutiques au cours de leur production. Le PAT et un composant central du concept plus général de Quality-by-Design (QbD) promu par les agence régulatrices et visant à construire la qualité des produits via une approche scientifique et la gestion des risques.Une méthode basée sur la spectroscopie proche infrarouge (PIR) a été développée comme un outil du PAT pour contrôler en ligne la cristallisation d'un principe
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Schaefer, Cédric. "A Process Analytical Technology (PAT) approach involving near infrared spectroscopy to control the manufacturing of an active pharmaceutical ingredient : development, validation and implementation." Electronic Thesis or Diss., Aix-Marseille, 2013. http://www.theses.fr/2013AIXM4375.

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Les entreprises pharmaceutiques ont progressivement adopté le concept de Process Analytical Technology (PAT) afin de contrôler et d'assurer en temps réel la qualité des produits pharmaceutiques au cours de leur production. Le PAT et un composant central du concept plus général de Quality-by-Design (QbD) promu par les agence régulatrices et visant à construire la qualité des produits via une approche scientifique et la gestion des risques.Une méthode basée sur la spectroscopie proche infrarouge (PIR) a été développée comme un outil du PAT pour contrôler en ligne la cristallisation d'un principe
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Cermikli, Can. "A Static Analysis Approach For Service Oriented Software Engineering (sose) Designs." Master's thesis, METU, 2010. http://etd.lib.metu.edu.tr/upload/12612317/index.pdf.

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In this thesis, a static analysis approach is introduced in order to develop correct business processes according to the Web Service Business Process Execution Language (WS-BPEL) specification. The modeling of the business processes are conducted with Business Process Execution Language (BPEL) which is a popular orchestrator of Service Oriented Architectures (SOA) based system through the description of workflow. This approach is also integrated to the Service Oriented Software Engineering (SOSE) design technique. The integration of this approach aims the development of complex business proces
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Hernandez, Tony. "Test Procedure Validation Process." Digital Commons at Loyola Marymount University and Loyola Law School, 2011. https://digitalcommons.lmu.edu/etd/401.

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In System Test, there is currently no common test procedure validation process across commercial, civil and government programs. Enterprise processes simply state to perform verification and validation. The method of satisfying that requirement is left to each individual organization and/or program. The process is generic in order to support an Enterprise of products that can vary from military weapons to commercial satellites. A common test procedure validation process can be adopted which is platform and program independent to provide more guidance than the top level Enterprise process. The
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Brioschi, E. "POTENTIAL MITOCHONDRIAL REGULATORS: FUNCTIONAL VALIDATION BY INTEGRATED APPROACHES." Doctoral thesis, Università degli Studi di Milano, 2014. http://hdl.handle.net/2434/232586.

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As sites of the main oxidative reactions and of the electron transport chain, mitochondria are the organelle committed to metabolic energy production required for all cellular functions. Because of their ubiquitous presence, mitochondrial density and function have a significant impact on whole-body metabolism. Many aspects at the basis of mitochondrial regulation have not been fully deciphered; hence, finding new mitochondrial regulators is a major challenge, both for basic science and for translational medicine. Integrating different approaches like high-throughput screening, staining assays
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Bhargava, Abhishek. "Adaptive process monitoring and sensor validation." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 2001. http://www.collectionscanada.ca/obj/s4/f2/dsk3/ftp04/MQ60413.pdf.

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Books on the topic "And Approaches of Process Validation"

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1942-, Berry Ira R., and Nash Robert A. 1930-, eds. Pharmaceutical process validation. 2nd ed. Marcel Dekker, 1993.

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1942-, Berry Ira R., and Nash Robert A. 1930-, eds. Pharmaceutical process validation. 3rd ed. Marcel Dekker, 2003.

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1942-, Berry Ira R., and Nash Robert A. 1930-, eds. Pharmaceutical process validation. 3rd ed. Marcel Dekker, 2003.

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Gail, Sofer, and Zabriskie Dane W. 1950-, eds. Biopharmaceutical process validation. Marcel Dekker, 2000.

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Pazhayattil, Ajay Babu, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, and Jordan Collins. Solid Oral Dose Process Validation. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-030-02472-7.

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Colloby, Jennifer. The validation process for EYPS. 2nd ed. Learning Matters, 2009.

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Colloby, Jennifer. The validation process for EYPS. Learning Matters, 2008.

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Colloby, Jennifer. The validation process for EYPS. 2nd ed. Learning Matters, 2009.

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Sofer, G. K., and Anurag S. Rathore. Process validation in manufacturing of biopharmaceuticals. 3rd ed. Taylor & Francis/CRC Press, 2012.

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Singh Rathore, Anurag, Hal Baseman, and Scott Rudge. Process Validation in Manufacturing of Biopharmaceuticals. 4th ed. CRC Press, 2023. http://dx.doi.org/10.1201/9781003143130.

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Book chapters on the topic "And Approaches of Process Validation"

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Haug, Michael, Eric W. Olsen, and Luisa Consolini. "Software Process Improvement A European View." In Software Quality Approaches: Testing, Verification, and Validation. Springer Berlin Heidelberg, 2001. http://dx.doi.org/10.1007/978-3-642-56612-7_1.

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Harrington, Alison C. E. "Validation of Process Analytical Technology Applications." In Practical Approaches to Method Validation and Essential Instrument Qualification. John Wiley & Sons, Inc., 2012. http://dx.doi.org/10.1002/9780470630716.ch4.

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Paetzold, K., and J. Reitmeier. "Approaches for Process Attendant Property Validation of Products." In Modelling and Management of Engineering Processes. Springer London, 2010. http://dx.doi.org/10.1007/978-1-84996-199-8_3.

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Shukla, Shiv Shankar, Ravindra Kumar Pandey, Beena Gidwani, and Gunjan Kalyani. "Process Validation and Its Types." In Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach. Springer Nature Singapore, 2023. http://dx.doi.org/10.1007/978-981-19-9002-1_10.

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Pazhayattil, Ajay Babu, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, and Jordan Collins. "Life Cycle Approach to Process Validation." In AAPS Introductions in the Pharmaceutical Sciences. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-030-02472-7_1.

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Shukla, Shiv Shankar, Ravindra Kumar Pandey, Beena Gidwani, and Gunjan Kalyani. "Approach to the Qualification Process." In Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach. Springer Nature Singapore, 2023. http://dx.doi.org/10.1007/978-981-19-9002-1_6.

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Hage, Hassan, Emmanouil Seferis, Vahid Hashemi, and Frank Mantwill. "SMC4PEP: Stochastic Model Checking of Product Engineering Processes." In Fundamental Approaches to Software Engineering. Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-99429-7_9.

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AbstractProduct Engineering Processes (PEPs) are used for describing complex product developments in big enterprises such as automotive and avionics industries. The Business Process Model Notation (BPMN) is a widely used language to encode interactions among several participants in such PEPs. In this paper, we present SMC4PEPl as a tool to convert graphical representations of a business process using the BPMN standard to an equivalent discrete-time stochastic control process called Markov Decision Process (MDP). To this aim, we first follow the approach described in an earlier investigation to
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Aschenbruck, Rabea, Gero Szepannek, and Adalbert F. X. Wilhelm. "Stability of Mixed-Type Cluster Partitions for Determination of the Number of Clusters." In Studies in Classification, Data Analysis, and Knowledge Organization. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-09034-9_6.

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AbstractFor partitioning clustering methods, the number of clusters has to be determined in advance. One approach to deal with this issue are stability indices. In this paper several stability-based validation methods are investigated with regard to the k-prototypes algorithm for mixed-type data. The stability-based approaches are compared to common validation indices in a comprehensive simulation study in order to analyze preferability as a function of the underlying data generating process.
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Liu, Jialin. "Chemical Process Fault Diagnosis Based on Sensor Validation Approach." In Intelligent Information and Database Systems. Springer Berlin Heidelberg, 2012. http://dx.doi.org/10.1007/978-3-642-28487-8_7.

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Casaluce, Roberto, Andrea Burattin, Francesca Chiaromonte, and Andrea Vandin. "Process Mining Meets Statistical Model Checking: Towards a Novel Approach to Model Validation and Enhancement." In Business Process Management Workshops. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-25383-6_18.

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Conference papers on the topic "And Approaches of Process Validation"

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Akundi, Sahithi Srijana, Yuanxing Liu, Austin Braniff, et al. "Integrating Dynamic Risk Assessment with Explicit Model Predictive Control via Chance-Constrained Programming." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.176554.

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Maintaining operational efficiency while ensuring safety is a longstanding challenge in industrial process control, particularly in high-risk environments. This paper presents a novel Dynamic Risk-Informed Explicit Model Predictive Control (R-eMPC) framework that integrates safety and operational objectives using probabilistic constraints and real-time risk assessments. Unlike traditional approaches, this framework dynamically adjusts safety thresholds based on Bayesian updates, ensuring a balanced trade-off between reliability and efficiency. The validation of this approach is illustrated thr
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Herrera-Ruiz, Juan Federico, Javier Fontalvo, and Oscar Andr�s Prado-Rubio. "Hybrid model development for Succinic Acid fermentation: relevance of ensemble learning for enhancing model prediction." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.153338.

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Sustainable development goals have spurred advancements in bioprocess design, driven by improved process monitoring, data storage, and computational power. High-fidelity models are essential for advanced process system engineering, yet accurate parametric models for bioprocessing remain challenging due to overparameterization, often resulting in poor predictive accuracy. Hybrid modeling, combining parametric and non-parametric methods, offers a promising solution by enhancing accuracy while maintaining interpretability. This study explores hybrid models for succinic acid fermentation by Escher
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Aboagye, Emmanuel A., Austin L. Lehr, Ethan Shumaker, et al. "Machine Learning Methods for the Forecasting of Environmental Impacts in Early-stage Process Design." In Foundations of Computer-Aided Process Design. PSE Press, 2024. http://dx.doi.org/10.69997/sct.141240.

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Initial design stages are inherently complex and often lack comprehensive information, posing challenges in evaluating sustainability metrics. Machine Learning (ML) emerges as a valuable solution to address these challenges. ML algorithms, particularly effective in predicting environmental impacts of new chemicals with limited data, enable more informed decisions in sustainable design. This study focuses on employing ML for predicting the environmental impacts related to human health, ecosystem quality, climate change, and resource utilization to aid in early-stage environmental impact assessm
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Gurvich, Mark, Mark Robeson, and SeungBum Kim. "Progressive Damage in Rotorcraft Composite Structures as Random Process: Integration of Characterization, Modeling and Validation." In Vertical Flight Society 73rd Annual Forum & Technology Display. The Vertical Flight Society, 2017. http://dx.doi.org/10.4050/f-0073-2017-12165.

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This work is aimed to address the random nature of the progressive damage process (PDP) in laminated composite structures for enhancement of engineering solutions and decision-making based on damage tolerance assessment (DTA). A general approach integrating input characterization, output validation, and corresponding modeling solutions is suggested for understanding and quantification of inevitable randomness of multi-step PDP in laminated composites and components. A general modeling approach of probabilistic PDP is developed based on system definition of laminated composites consisting of el
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Kok, Yu Hui, and Yasuki Kansha. "Modelling of Wood Biomass Gasification for Process Optimization." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.122887.

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Biomass gasification is a promising technology for sustainable energy production. To date, extensive research has been conducted on biomass gasification, particularly focusing on the reaction models of the process. However, existing models are too complex to apply to the control system or to optimize the process operating conditions effectively, limiting their practical use for industrial applications. To address this, a simple reaction model for biomass gasification was developed and validated. A steady state simulation of the biomass gasification process is conducted to analyze gasifier beha
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Anderko, A., N. Sridhar, C. S. Brossia, et al. "An Electrochemical Approach to Predicting and Monitoring Localized Corrosion in Chemical Process Streams." In CORROSION 2003. NACE International, 2003. https://doi.org/10.5006/c2003-03375.

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Abstract A general model for predicting the occurrence of localized corrosion in chemical process streams is described. The model predicts the repassivation and corrosion potentials based on input chemistry of a system. The model predictions are compared to experimental data. Initial data from a validation study using a multielectrode array sensor at a process plant is described.
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Rogers, Alexander W., Amanda Lane, Philip Martin, and Dongda Zhang. "AI-Driven Automatic Mechanistic Model Transfer Learning for Accelerating Process Development." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.167600.

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Accurate mechanistic models provide valuable physical insight and are crucial for efficient process scale-up and optimisation, but their identification requires lengthy experimental data collection, model construction, validation and discrimination. Traditional black-box machine learning transfer methods leverage prior knowledge but lack interpretability and physical insights. To address this, we propose a novel approach using artificial neural network feature attribution to automatically locate corrections and symbolic regression to make structural modifications to an inaccurate or low-fideli
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Kensy, Mark Dennis, Ingor Baumann, Jonas Zajaczkowski, Leif Hagen, and Wolfgang Tillmann. "Optimization of Cr?C?-NiCr Coatings Using ID-HVOF: A Statistical Approach to Key Process Parameters." In ITSC 2025. ASM International, 2025. https://doi.org/10.31399/asm.cp.itsc2025p0287.

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Abstract This study investigates the application of a commercially available Cr?C?-NiCr powder using the ID-HVOF coating process. A central composite design within a design of experiments framework was employed to analyze the effects of key process parameters—kerosene flow, hydrogen flow, oxygen flow, and the powder feed rate—on the coating performance. The validation test successfully produced a coating that matches the predicted parameters from the design framework.
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Monaco, Jeffrey, Mark Davis, Roberto Semidey, Jason Hull, Raymond Beale, and Mark Glucksman-Glaser. "Maneuver Generation for Regime Recognition Design and Validation." In Vertical Flight Society 74th Annual Forum & Technology Display. The Vertical Flight Society, 2018. http://dx.doi.org/10.4050/f-0074-2018-12771.

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Accurate characterization of fleet and individual aircraft usage spectrums would allow component retirement times to be based on actual aircraft usage rather than on an assumed worst case usage spectrum used in a traditional time-based maintenance approach. A key enabling technology for such a Usage or Condition Based Maintenance (UBM/CBM) program is Regime Recognition (RR). The development and validation of such algorithms commonly employs flight loads survey data, which captures critical regimes and the corner points of the operational envelope. Such maneuver examples are flown precisely and
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"PROCESS MODEL VALIDATION - Transforming Process Models to Extended Checking Models." In International Conference on Evaluation of Novel Approaches to Software Engineering. SciTePress - Science and and Technology Publications, 2010. http://dx.doi.org/10.5220/0003016602140220.

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Reports on the topic "And Approaches of Process Validation"

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Cetin, Ali, and Rainer Dahlmann. Recyclates for sustainable food contact method development for the validation of migration barriers. Universidad de los Andes, 2024. https://doi.org/10.51573/andes.pps39.ss.cep.3.

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Ideological changes in industrial approaches require greater ecological thinking. Regarding plastics, the integration of plastic waste into the circular economy arises from the urgent need to design and develop sustainable alternatives. The primary objective of a recycling process is to ensure that the quality of recycled plastics consistently matches that of the original product. Regional authorities and regulations require the assessment and prevention of the potential safety hazards of possible contaminants in recycling streams, recycling processes, and recycling technologies. The specific
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Kuhn, W. L., M. R. Toland, and B. A. Pulsipher. Process simulation and statistical approaches for validating waste form qualification models. Office of Scientific and Technical Information (OSTI), 1989. http://dx.doi.org/10.2172/6238707.

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Fitzlaff, Milan, Gibran Khoury, Moritz Käß, Martin Werz, Bernd Gundelsweiler, and Stefan Weihe. Investigations on injection mold inserts with reduced thermal masses using additive manufacturing. Universidad de los Andes, 2024. https://doi.org/10.51573/andes.pps39.gs.im.3.

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This work examined previously developed injection mold inserts with reduced thermal mass, with regard to lightweight construction approaches. These were optimised for oil-variothermal temperature control using simulative support. Additive manufacturing (AM), with its high degree of freedom in design, enables the implementation of individual, conformal cooling channels and can additionally support the efficiency of the variothermal process. The thermal mass of the injection mold is often a limiting factor in terms of process efficiency, which is also addressed in the analysis and optimisation c
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Wimart-Rousseau, Cathy, Marine Fourrier, and Fiedler Björn. Development of BGCArgo data quality validation based on an integrative multiplatform approach. EuroSea, 2022. http://dx.doi.org/10.3289/eurosea_d7.2.

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This report presents the results of Task 7.3 on “Development of BGC-Argo data quality validation based on an integrative multiplatform approach”. Observing changes in ocean conditions on the spatiotemporal scales necessary to constrain carbon uptake is a challenge. Defined as an Essential Ocean Variable (EOV) by the Global Ocean Observing System (GOOS, e.g., Tanhua et al., 2019), pH is relevant to assess numerous crucial questions regarding the oceanic evolution in response to the current global changes. However, the large spatiotemporal variability of this carbonate system parameter requires
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Palkovic, Steven, Yasamin Salamat, Brendon Willey, and Simon Bellemare. PR-610-183867-R01 Fracture Toughness via In-ditch Non-destructive Testing - Validation. Pipeline Research Council International, Inc. (PRCI), 2020. http://dx.doi.org/10.55274/r0011802.

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A challenge for many pipeline operators is missing or incomplete records for sections of their transmission pipeline networks, especially regarding fracture toughness properties. These toughness values are necessary for performing fitness for service calculations and engineering critical assessment. New regulations for gas transmission pipelines stipulate conservative default values for applicable assets when traceable, verifiable, and complete (TVC) records are not available. The new rules allow for the use of nondestructive techniques within material verification programs to measure the actu
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Ferguson, James. PR676-233801-R03 Circumferential Crack Hazard POF Analysis Process. Pipeline Research Council International, Inc. (PRCI), 2025. https://doi.org/10.55274/r0000140.

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Pipelines that traverse areas of active ground movement may be subject to Tensile Strain Demand (TSD) due to soil-pipe interaction. Independently, the pipe may have locations with reduced Tensile Strain Capacity (TSC) stemming from construction practices or due to pre-existing pipe wall defects, girth weld anomalies, or Circumferential Stress Corrosion Cracking (CSCC). The confluence of elevated TSD and reduced TSC presents a susceptibility to Loss of Containment (LOC) due to circumferential cracking. This study provides a methodology to identify segments and sites with circumferential crackin
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Huang, Haohang, Erol Tutumluer, Jiayi Luo, Kelin Ding, Issam Qamhia, and John Hart. 3D Image Analysis Using Deep Learning for Size and Shape Characterization of Stockpile Riprap Aggregates—Phase 2. Illinois Center for Transportation, 2022. http://dx.doi.org/10.36501/0197-9191/22-017.

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Riprap rock and aggregates are extensively used in structural, transportation, geotechnical, and hydraulic engineering applications. Field determination of morphological properties of aggregates such as size and shape can greatly facilitate the quality assurance/quality control (QA/QC) process for proper aggregate material selection and engineering use. Many aggregate imaging approaches have been developed to characterize the size and morphology of individual aggregates by computer vision. However, 3D field characterization of aggregate particle morphology is challenging both during the quarry
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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis,
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Kanninen, M. F. L51718 Development and Validation of a Ductile Fracture Analysis Model. Pipeline Research Council International, Inc. (PRCI), 1994. http://dx.doi.org/10.55274/r0010321.

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In close cooperation with the Centro Sviluppo Materiali (CSM) and SNAM of Italy, with several years of support from the PRCI NG-18 committee, the Southwest Research Institute (SwRI) has developed and validated a "first principles" predictive model for ductile fracture in a gas transmission pipeline. In particular, the coordinated SwRI and CSM projects for the PRC -supplemented by work contributed by SNAM - has established a theoretically valid methodology and an accompanying line pipe material characterization procedure for gas industry use. This progress provides a theoretically sound framewo
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Lewis, John E., Christine M. English, Joshua C. Gesick, and Saikrishna Mukkamala. Validation Process Methods. Office of Scientific and Technical Information (OSTI), 2018. http://dx.doi.org/10.2172/1416523.

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