Quality Of Compliance Research Articles

Connecting Water Quality and Ecosystem Services for Valuation and Assessment of a Groundwater Reserve Area in South-East Mexico

Even though the role of ecosystem services is known, the identification and assessment of water-related services is usually absent or often less represented as an ecosystem service. Progress in water quality indicator definition and compliance with regulations has been made; however, the relationship between water quality degradation and benefits to individuals and ecosystems remains little recognized. Here, we present an assessment of water quality and identification of ecosystem services in south-east Mexico. This study was performed within the geohydrological reserve zone of the Ring of Sinkholes, Yucatán Peninsula. Thirteen ecosystem services provided by the aquifer were identified. Water quality was evaluated in sinkholes based on national and international norms, considering different sinkhole uses. Results show a dynamic system, without saltwater intrusion and good to excellent water quality. The research demonstrates the relationship between ecosystem services and water quality, showing pressure in services related to uses for aquatic life protection and to a lesser extent those related to consumption. Current productive activities showed no pressure at this time. Principal Component Analysis (PCA) and Analysis of Variance (ANOVA) exhibited a significant difference in parameters and campaigns, but not between sinkholes. A long-lasting monitoring program for water quality is necessary to accurately evaluate the status of ecosystem services provided by the aquifer. Moreover, it is necessary to assess aquifers as ecosystems with economic, ecologic and socio-cultural importance. Effective water governance requires a balance of interests between all parties, within a legal and institutional framework.

Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials

BackgroundRisk-based quality management is a regulatory-recommended approach to manage risk in a clinical trial. A key element of this strategy is to conduct risk-based monitoring to detect potential risks to critical data and processes earlier. However, there are limited publicly available tools to perform the analytics required for this purpose. Good Statistical Monitoring is a new open-source solution developed to help address this need.MethodsA team of statisticians, data scientists, clinicians, data managers, clinical operations, regulatory, and quality compliance staff collaborated to design Good Statistical Monitoring, an R package, to flexibly and efficiently implement end-to-end analyses of key risks. The package currently supports the mapping of clinical trial data from a variety of formats, evaluation of 12 key risk indicators, interactive visualization of analysis results, and creation of standardized reports.ResultsThe Good Statistical Monitoring package is freely available on GitHub and empowers clinical study teams to proactively monitor key risks. It employs a modular workflow to perform risk assessments that can be customized by replacing any workflow component with a study-specific alternative. Results can be exported to other clinical systems or can be viewed as an interactive report to facilitate follow-up risk mitigation. Rigorous testing and qualification are performed as part of each release to ensure package quality.ConclusionsGood Statistical Monitoring is an open-source solution designed to enable clinical study teams to implement statistical monitoring of critical risks, as part of a comprehensive risk-based quality management strategy.

The Information Technology (IT) Infrastructure of the Multicenter Archipelago of Ovarian Cancer Research Biobank: A Potential Blueprint for Other Biobanks.

Objective: Biobanks play a crucial role in fundamental and translational research by storing valuable biomaterials and data for future analyses. However, the design of their information technology (IT) infrastructures is often customized to specific requirements, thereby lacking the ability to be used for biobanks comprising other (types of) diseases. This results in substantial costs, time, and efforts for each new biobank project. The Dutch multicenter Archipelago of Ovarian Cancer Research (AOCR) biobank has developed an innovative, reusable IT infrastructure capable of adaptation to various biobanks, thereby enabling cost-effective and efficient implementation and management of biobank IT systems. Methods and Results: The AOCR IT infrastructure incorporates preexisting biobank software, mainly managed by Health-RI. The web-based registration tool Ldot is used for secure storage and pseudonymization of patient data. Clinicopathological data are retrieved from the Netherlands Cancer Registry and the Dutch nationwide pathology databank (Palga), both established repositories, reducing administrative workload and ensuring high data quality. Metadata of collected biomaterials are stored in the OpenSpecimen system. For digital pathology research, a hematoxylin and eosin-stained slide from each patient's tumor is digitized and uploaded to Slide Score. Furthermore, adhering to the Findable, Accessible, Interoperable, and Reusable (FAIR) principles, genomic data derived from the AOCR samples are stored in cBioPortal. Conclusion: The IT infrastructure of the AOCR biobank represents a new standard for biobanks, offering flexibility to handle diverse diseases and types of biomaterials. This infrastructure bypasses the need for disease-specific, custom-built software, thereby being cost- and time-effective while ensuring data quality and legislative compliance. The adaptability of this infrastructure highlights its potential to serve as a blueprint for the development of IT infrastructures in both new and existing biobanks.

A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023

To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process.

Comparative analysis of diversification-marketing challenges faced by farmers in North India

This study delves into the dynamics of crop diversification, offers a comparative analysis, and explores the marketing challenges confronting farmers in northern India. Crop diversification has gained prominence as a sustainable agricultural practice necessitated by ecological concerns and market fluctuations. Drawing from a wide array of secondary sources, including government reports, academic literature, and agricultural data, this research investigates the evolution of crop diversification in different regions. We scrutinize the diversification trends in North India, highlighting the shifts in crop choices such as rice, wheat, pulses, and cash crops. In parallel, we address the multifaceted marketing challenges faced by farmers across these regions. This includes the influence of intermediaries, price volatility, logistical constraints, and quality compliance issues. We explore the varying impacts of government policies and schemes in alleviating these challenges. Furthermore, the research reveals that effective marketing solutions are pivotal for guaranteeing equitable returns for farmers diversifying their crops. The role of government interventions emerges as a critical factor in this context.

Power quality assessment and compliance of grid-connected PV systems in low voltage networks using microinverters

AbstractSolar PV has experienced unprecedented growth in the last decade, with the most significant additions being utility-scale solar PV. The role of grid inverters is very critical in feeding power from distributed sources into the grid. With the increasing growth of grid-tied solar PV systems (both rooftop and large-scale), the awareness of power quality issues has risen with new regulations and standards to ensure the stability of the power grid. The power quality of microinverters has been investigated under steady solar irradiation and PV power source and also under real outdoor conditions in compliance with the accepted solar PV integration requirements. The current total harmonic distortion (THD) measured for the studied microinverter under outdoor conditions far exceeded the current THD for the study under steady indoor conditions and was beyond the accepted standard. However, the voltage THD outputs for the two studied cases were in good agreement with the grid codes. The voltage and current THD for the 400 Wm−2 (60 Wp) and the 1000 Wm−2 (146 Wp) scenarios under the steady solar irradiation (solar PV power) were 2.24%, 13%, and 2.27, 6.93%, respectively. The voltage and current THDs for the outdoor study were 2.03% and 14.28% for Solarex (pc-Si module), 1.94%, and 27.43% for Juta (mc-Si modules), and 1.97% and 33.6% for Dunasolar (a-Si glass module). Results showed a strong correlation between the intermittence of solar radiation and the current THD. 67%, 54%, and 37% of the recorded power factor for Dunasolar, Juta, and Solarex modules, respectively, exceeded the limits prescribed by the standards.

A Comprehensive Review on Implementation of Quality by Design in Varied Pharmaceutical Formulations

This review article investigates how Quality by Design (QbD) ideas are used in different pharmaceutical development processes, such as the creation of analytical methods, formulation optimization, and nanoparticle production. In order to improve product quality, reliability, and regulatory compliance, it covers a variety of studies that use QbD approaches. Critical quality attributes and process variables are discovered and optimized to meet desired product characteristics through systematic methodologies such as central composite design, factorial design, and response surface analysis. The experiments demonstrate the adaptability and effectiveness of the QbD strategy in pharmaceutical development by examining a range of drug delivery systems, including lipid nanoparticles and fast dissolving tablets. The significance of QbD is emphasized in the article as a means of guaranteeing uniform product quality, fulfilling regulatory obligations, and enhancing patient outcomes.

How Tax Compliance, Audit Quality, and Financial Reporting Quality on Corporate Financial Performance in Manufacturing Companies

Within the framework of Indonesian manufacturing enterprises, this study explores the intricate links between tax compliance, audit quality, financial reporting quality, and firm financial performance. Using Structural Equation Modeling with Partial Least Squares (SEM-PLS), a sample of 175 firms was examined. The effect of these variables on financial performance was evaluated using correlation analysis, hypothesis testing, and descriptive statistics. The findings show a strong positive correlation between business financial performance, financial reporting quality, audit quality, and tax compliance. This study adds to the body of knowledge by providing complex insights specific to the Indonesian manufacturing industry. These insights can be used by investors, policy makers, regulators, and firm management to enhance decision-making procedures and promote sustainable financial practices in the sector.

FAIRness in digital forensics datasets’ metadata – and how to improve it

The availability of research data (datasets) and compliance with FAIR principles—Findability, Accessibility, Interoperability, and Reusability—is critical to progressing digital forensics. This study evaluates metadata completeness and assesses the alignment with the FAIR principles using all 212 datasets from NIST's Computer Forensic Reference DataSet Portal (CFReDS). The findings underscore deficiencies in metadata quality and FAIR compliance, emphasizing the need for improved data management standards. Based on our critical review, we then propose and discuss various approaches to improve the status quo.

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2023 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) are published in volume 16 of Bioanalysis, issues 8 and 9 (2024), respectively.

AI will change EA practice – but are we ready for it? A call for discussion based on developments in collecting and processing biodiversity data

ABSTRACT The opportunities and potential of advanced digitalisation involving the application of Artificial Intelligence (AI) in Environmental Assessment (EA) are often mentioned across international studies. However, it is essential for us in EA research and practice to comprehensively grasp the implications of this transformation and proactively prepare for the imminent changes. In this context and drawing on insights from biological sciences, this letter examines the established use, prospects and risks of these technological advances in the field of species, habitat and biodiversity related data and its analysis. We aim to initiate a thought-provoking dialogue across diverse groups of EA actors regarding the practical implications of AI for EA, highlighting new roles and evolving skills needed to guarantee quality and legal compliance. Central to this discussion is the origination of data, alongside the distribution of responsibilities across actors/stakeholders involved in EA with regard to data collection, sharing and interpretation. Key considerations regard the quality and integrity of AI-supported and systematically collected data and the prevention of potential manipulation. We emphasise the need to re-evaluate education and training programs, adapt practices, and enhance decision-making processes as initial steps toward establishing a focused research agenda.

Services Quality or Sharia Compliance? Factors which mostly Influence Customer Selection of Islamic Banks – The Case of Tanzania

In the realm of banking, Islamic banking concepts and practices may appear unfamiliar to certain customers, particularly those transitioning from conventional banking systems. The perception of customers is significantly influenced by the level of education and awareness imparted by the banks themselves. Moreover, it is widely believed that customer perception directly impacts their satisfaction levels. Within Tanzania, the Islamic banking sector has experienced modest growth in recent years. This study aims to delve into the perception held by customers regarding Islamic Banks’ adherence to Shariah principles in their operations. Also, it aims to understand the factors that attract customers to Islamic banks instead of conventional ones. This research focuses on the Islamic banking industry in Tanzania, covering both the mainland and the Island of Zanzibar. A total of 305 Islamic bank customers participated in this study by completing a close-ended questionnaire. Using a descriptive research design, this study examined four key factors: the banks’ compliance with Shariah principles, customers’ awareness of Islamic banking products and services, criteria used by customers when selecting a bank, and customer satisfaction with the quality of services offered. The findings showed that the majority of Islamic bank customers in Tanzania perceived these banks to be operating in accordance with Shariah law. This study also highlighted that Shariah compliance was the primary influencing factor in choosing an Islamic bank over a conventional followed by service quality. Therefore, Islamic banks in Tanzania should focus on providing more education about Islamic banking and ensuring that their products align with Islamic law.

Development of a single nucleotide polymorphism–based strain-identified method for Streptococcus thermophilus CICC 6038 and Lactobacillus delbrueckii ssp. bulgaricus CICC 6047 using pan-genomics analysis

The health benefits conferred by probiotics is specific to individual probiotic strains, highlighting the importance of identifying specific strains for research and production purposes. Streptococcus thermophilus CICC 6038 and Lactobacillus delbrueckii ssp. bulgaricus CICC 6047 are exceedingly valuable for commercial use with an excellent mixed-culture fermentation. To differentiate these 2 strains from other S. thermophilus and L. delbrueckii ssp. bulgaricus, a specific, sensitive, accurate, rapid, convenient, and cost-effective method is required. In this study, we conducted a pan-genome analysis of S. thermophilus and L. delbrueckii ssp. bulgaricus to identify species-specific core genes, along with strain-specific single-nucleotide polymorphisms (SNPs). These genes were used to develop suitable PCR primers, and the conformity of sequence length and unique SNPs was confirmed by sequencing for qualitative identification at the strain level. The results demonstrated that SNPs analysis of PCR products derived from these primers could distinguish CICC 6038 and CICC 6047 accurately and reproducibly from the other strains of S. thermophilus and L. delbrueckii ssp. bulgaricus, respectively. The strain-specific PCR method based on SNPs herein is universally applicable for probiotics identification. It offers valuable insights into identifying probiotics at the strain level that is fit-for-purpose in quality control and compliance assessment of commercial dairy products.

A ternary nucleotide-lanthanide coordination nanoprobe for ratiometric fluorescence detection of ciprofloxacin.

Ciprofloxacin (CIP) is a widely used broad-spectrum antibiotic and has been associated with various side effects, making its accurate detection crucial for patient safety, drug quality compliance, and environmental and food safety. This study presents the development of a ternary nucleotide-lanthanide coordination nanoprobe, GMP-Tb-BDC (GMP: guanosine 5'-monophosphate, BDC: 2-amino-1,4-benzenedicarboxylic acid), for the sensitive and ratiometric detection of CIP. The GMP-Tb-BDC nanoprobe was constructed by incorporating the blue-emissive ligand BDC into the Tb/GMP coordination polymers. Upon the addition of CIP, the fluorescence of terbium ion (Tb3+ ) was significantly enhanced due to the coordination and fluorescence sensitization properties of CIP, while the emission of the BDC ligand remained unchanged. The nanoprobe demonstrated good linearity in the concentration range of 0-10 μM CIP. By leveraging mobile phone software to analyze the color signals, rapid on-site analysis of CIP was achieved. Furthermore, the nanoprobe exhibited accurate analysis of CIP in actual drug and milk samples. This study showcases the potential of the GMP-Tb-BDC nanoprobe for practical applications in CIP detection.

Visible particles in parenteral drug products: A review of current safety assessment practice

Parenteral drug products (PDPs) are administered extensively to treat various diseases. Product quality plays a critical role in ensuring patient safety and product efficacy. One important quality challenge is the contamination of particles in PDPs. Particle presence in PDPs represents potential safety risk to patients. Differential guidance and practice have been in place for visible (VPs) and subvisible particles (SVPs) in PDPs. For SVPs, the amount limits have been harmonized in multiple Pharmacopeias. The pharmaceutical industry follows the guided limits for regulatory and quality compliance. However, for VPs, no such acceptable limit has been set. This results in not only quality but also safety challenges for manufacturers and drug developers in managing and evaluating VPs. It is important to understand the potential safety risk of VPs so these can be weighed against the benefit of the PDPs. To evaluate their potential risk(s), it is necessary to understand their nature, origin, frequency of their occurrence, safety risk, the risk mitigation measures, and the method to evaluate their safety. The current paper reviews the critical literature on these aspects and provides insight into considerations when performing safety assessment and managing the risk(s) for VPs in PDPs.

An Economic Model of Media Ethics

Ethics and economic profits are considered to be trade-offs to one another. Akin to other disciplines, private media face the same dilemma. Pursuing more economic profit through increased viewership, advertising rates, or other practices usually comes at the cost of diminished ethical compliance. However, many studies highlight the importance of ethical guidelines in increasing revenues and profits in media organizations. This article aims to reconcile previous scholarship on the subject and develop an economic model of media ethics. The model is based on the literature and methodology of public economics, particularly that of public goods and externalities. It predicts that private media firms, when left to the perfectly competitive market, produce a greater quantity of news that may not be socially desirable and is of low quality and poor ethical compliance. When the social cost of producing ethical and quality media products is considered, the revenue of the private firms decreases, thereby suggesting an inverse relationship between ethical compliance and profits. This demands a case for libertarian paternalism, nudges, or incentives to restore private firms to the socially optimal equilibrium to ensure independent, ethical, free, and sustainable media.

Hierarchical Component Model Approach on Tax Fairness, Public Governance Quality and Tax Compliance: A Mediating Role of Tax Morale

This study assesses the effect of tax fairness, public governance quality on tax compliance of MSEs in North-Eastern States of Nigeria through tax morale. The study population is 124,231 registered MSEs in North-Eastern states of Nigeria where sample of 527 MSEs was used. PLS-SEM was employed to ensure data analysis and hypotheses testing. Internal consistency reliability and validity checks were carried out to ensure that the measurement instrument is reliable and valid for data collection. The findings of the study revealed that direct assessment tax compliance is found to have been positively influenced by public governance quality and tax morale while, tax compliance was not significantly explained by tax fairness. Moreover, tax morale mediated the effect of public governance quality on tax compliance while no mediation was experience on tax system fairness and direct assessment tax compliance. Hence, the study contributed to the existing body of literature and tax authorities were adequately provided with an insight into improving tax compliance of direct assessment taxpayers through tax morale by public governance quality .

IMPLEMENTASI SISTEM MUTU INTERNAL UNTUK MENINGKATKAN MUTU PENDIDIKAN DASAR

To implement state education goals, internal quality assurance is carried out in relation to national education standards. Internal quality is now applied not only to higher education, but also to primary and secondary education. We continue to ensure and lead educational quality assurance and compliance in primary and secondary school units. The aim of this research is to determine and describe the implementation of the internal quality system cycle. The techniques used in data collection are: Observation, interviews, documentary research. The results of the research show that the quality improvement steps implemented at Bawamai Pontianak Elementary School are in accordance with the SPMI cycle steps including: First, school self-evaluation based on education quality certificates; second, a plan to improve quality through the formation of a quality committee and analysis of the results of the Kermbali School self-evaluation; Implementation of quality improvement, fourth, evaluation of follow-up and results of quality improvement after quality improvement, and fifth, return to next year's quality plan. The results of implementing internal quality assurance influence a more innovative learning process, student and school performance, satisfaction and success of internal and external customers. Eight national education standards.

Enhancing Indoor Air Quality and Regulatory Compliance: An In-Depth Comparative Study on Ventilation Strategies and Their Impact on SARS-CoV-2 Transmission Risk

Enclosed-space ventilation plays a pivotal role in enhancing indoor air quality (IAQ). Various regulations and guidelines determine minimum fresh air requirements, varying by the application, country, etc. The present study employs real-time indoor CO2 measurements to calculate the actual air change rate (ACH) and models the building’s compliance with Chartered Institution of Building Services Engineers (CIBSE) guidelines to assess its impact on IAQ. The contaminant considered is the SARS-CoV-2 virus with multiple infectors, and the study calculates the virus’s transmission risk under different scenarios. Fresh air is assumed to be provided by mechanical or hybrid ventilation. The results reveal that the current building conditions are unacceptable, showing a significant gap from the recommended guideline rates. Meeting CIBSE recommendations ensures indoor air safety in terms of CO2 concentration. However, in extreme conditions with five infectors, findings show a 14% reduction in mechanical ventilation efficacy. Among the hybrid ventilation scenarios, combining CIBSE rates with natural ventilation, with a 30% door and window opening from the class outset, proves most effective in reducing the virus’s transmission risk, with a 58–70% reduction from the building’s current condition. Furthermore, implementing supplementary measures like air cleaners resulted in an additional 28–50% reduction in transmission risk.

Developing Innovative Nanomaterials as Adsorbents for Water Treatment and their Environmental Impact

Water treatment is paramount in tackling the increasingly pressing environmental issues associated with water contamination. The present study investigates the progression of novel nanomaterials as exceptionally effective adsorbents for water purification while also evaluating their potential ecological consequences. The significance of water treatment cannot be overstated when it comes to protecting the environment and ensuring public health. This is due to the intricate and varied pollutants that are brought into water sources from many sources of waste, such as household, industrial, and environmental concerns. Adsorbents are crucial in capturing and immobilizing contaminants, making them essential instruments in this particular setting. Nanomaterials have garnered attention as potential adsorbents owing to their notable specific surface area and adjustable features. These materials possess a large surface area, reactivity, and configurable surface chemistry, rendering them intriguing candidates for adsorption applications. This manuscript presents the Innovative Nanoparticles for Water Treatment Framework (INM-WTF). This innovative approach utilizes state-of-the-art nanoparticles to improve water treatment processes' efficiency significantly. The outcomes of the INM-WTF experiment include the following parameters: Pollutant Removal Efficiency of 96.5%, Permeate Flux of 395 L/m²h, Adsorption Capacity of 155 mg/g, Photocatalytic Degradation Rate of 85%/hour, Membrane Filtration Efficiency of 97.5%, and Water Quality Compliance of 1.7 µg/L. The results indicate significant progress in water treatment capabilities, emphasizing nanomaterials' potential to tackle environmental issues, enhance water quality, and guarantee adherence to rigorous regulatory benchmarks.