Secure and Privacy-Respecting Documentation for Interactive Manufacturing and Quality Assurance

Emerging global privacy mandates enforce strict requirements for biometric data protection, requiring encrypted processing throughout storage and computation phases. While full homomorphic encryption (FHE)-based face recognition ensures security on platforms like Elastic Compute Service (ECS), three critical compliance gaps persist: 1) about 500 ciphertext expansion in high-dimensional facial features, exceeding practical deployment thresholds, 2) vulnerabilities in live verification scenarios documented by ENISA (83% failure rate in 2024 audits), and 3) absence of mechanisms satisfying IND-CPA and IND-CCA2 standards. These limitations collectively undermine both regulatory adherence and operational efficiency in practical biometric systems. To address these gaps, this paper proposes a Hybrid Encryption with Facial Data Integrity Verification(HEFDIVS) scheme, which combines dimensionality reduction and hybrid encryption algorithms. Specifically, the scheme first realizes facial feature similarity calculation in the ciphertext domain without decryption. Then, the ISOMAP algorithm is applied to reduce the dimensionality of the facial data, thus alleviating the computational complexity in the ciphertext domain. Finally, based on FHE, a hybrid encryption algorithm combining SM2 and SM4 is introduced to enhance the security of the scheme. Experimental validation on the LFW and Faces94 datasets demonstrates mean recognition accuracy rates of 95.45% and 96.98% respectively, with 89% faster ciphertext computation time (0.028s) compared to pure FHE implementations in the ciphertext domain. The proposed scheme surpasses existing methods in accuracy-efficiency tradeoff while complying with IND-CPA (NIST SP 800-57) and IND-CCA2 (ISO 19772) security standards through hybrid SM2-SM4 authentication mechanisms.

The Study of a Contaminated Colonoscope

Design for Metallic Additive Manufacturing Machine with Capability for “Certify as You Build”

This paper reports on the design, development and evaluation of a novel process for quality assurance of assessments for entire educational programmes. The process was developed and tested by multidisciplinary teaching staff and consists of five phases: inventory, analyses, evaluation, planning change and realising change. The process for quality assurance was evaluated in three diverse programmes. The results show that the process forms a solid base for decisions on short-term as well as long-term quality improvements. It was also found to encourage the development of a quality culture and had an improving effect on the curriculum design, enhanced internal quality work and supported documentation for external quality assurance. The results show that the process has the capacity to engage and involve teachers and other internal stakeholders in the quality development of a range of educational programmes, promoting engaged change for improved quality in a higher education institution.

A tool for modelling the impact of regulatory compliance activities on the biomanufacturing industry

Quality assurance is a routine and indispensable part of the work of the Medizinische Dienst der Krankenversicherung (MDK) (Medical Services of statutory health insurance bodies in Germany). To optimize the internal organisational processes, a quality assurance system (QAS), certified by EQ Zert, Ulm (an accredited certifier of the TGA), was implemented for the first time in one of the departments of the MDK, namely, the hospital department. Employees and management consider the advantages to be as follows: the aims of the department are clearly described. the processes are now self-evident and more strictly observed, overlaps to other fields of the company are defined. Both an Error Management System with follow up measures, and a Project Management System to control projects have been implemented. The documentation system was standardized, and consequently relocating documents has become more streamlined. An MDK self-evaluation was performed as part of an internal audit. The audit showed that the QAS of the hospital department of the MDK in Hesse is indeed highly developed. It is anticipated that gradually other fields of the MDK will also be certified, to comply with the changing requirements.

Introduction Two major trends have been observed in the Democratic Republic of the Congo (DRC) over the past decades: the increasing number of licences issued to open wholesale pharmaceutical establishments and the circulation of medicines of questionable quality. These trends raise serious concerns about population health. Purpose The aim of this study was to assess compliance with Good Distribution Practices (GDP) and ISO 9001:2015 standards among wholesale pharmaceutical establishments (WPEs) operating in the Democratic Republic of the Congo. Methods This cross-sectional study was conducted from January to June 2025 in the city of Kinshasa. Twenty-five pharmaceutical depots were randomly selected from a total of 110 wholesale pharmaceutical establishments listed by ACOREP in Kinshasa Province. Data were collected using two assessment tools (one for GDP and the other for ISO 9001:2015), direct observation of infrastructure, and semi-structured interviews with managers. The collected data were analysed using the chi-squared test to assess homogeneity and heterogeneity between establishments. Results Statistical analysis revealed significant heterogeneity among the studied establishments. Of the 25 pharmaceutical warehouses assessed, the reported p-values varied according to the evaluated standards and parameters. Regarding GDP, only one parameter demonstrated homogeneity, namely the documentation system (p = 0.622). All other parameters showed significant heterogeneity: quality system (p = 0.0239), personnel (p = 0.001), medicine storage (p < 0.001), and information technology systems (p = 0.0295). For ISO 9001:2015, homogeneity was observed for leadership (p = 1), planning (p = 0.854), and performance evaluation (p = 0.638). However, heterogeneity was identified in organisational context (p < 0.001), support (p < 0.001), operational activities (p < 0.001), and continuous improvement (p = 0.0716). Conclusion Compliance with GDP and ISO 9001:2015 standards remains insufficient in the Democratic Republic of the Congo, particularly with regard to ensuring the quality and safety of medicines. Continuous auditing and inspection of wholesale pharmaceutical establishments are required nationwide, especially in Kinshasa, where more than 70% of such establishments are located. Continuing professional education on GDP and ISO standards for pharmacists and their staff must be strengthened according to a structured schedule. The role of the responsible pharmacist should also be reinforced, and warehouse owners must make substantial contributions to quality assurance efforts. The observed operational heterogeneity among wholesale pharmaceutical establishments compromises medicine quality assurance in Kinshasa. Urgent action by health authorities is required to safeguard the health security of the Congolese population.

Quality Assurance with BADO - A New Documentation System

Nursing care systems face significant challenges due to demographic changes, a workforce shortage, and rising demand for care services. Digital assistive technologies offer potential to address these challenges, but systematic and standardized nursing data are essential to evaluate both innovations and broader care processes. The Nursing Minimum Data Set (NMDS) provides a foundational framework for capturing structured information on nursing care, yet there is no international consensus on its core content, development, and practical use. This scoping review aims to map current international literature regarding (1) the core content elements of NMDS, (2) methodological approaches used in NMDS development, and (3) implementation and use of NMDS in different nursing settings. Following the JBI (Joanna Briggs Institute) methodology and Arksey and O'Malley framework, a systematic search was conducted on July 2, 2025, in the MEDLINE (via PubMed) and CINAHL (via EBSCO) databases using the term "nursing minimum data set." Inclusion was restricted to studies in English or German focusing on the content, development, or implementation of the NMDS. The research team reviewed studies in an independent and double-blinded fashion for eligibility based on predefined criteria, with discrepancies resolved by consensus. Eligible studies were narratively summarized, with extraction structured into categories based on the review's research questions. From 1908 initially identified articles, 26 (1.4%) studies met the inclusion criteria. Considerable heterogeneity was found in the structure and scope of the NMDS, with datasets comprising 16 to 145 items. Despite variation, 4 central domains consistently emerged: patient demographics, medical care information, nursing care elements, and institutional or organizational data. NMDS development typically followed a participatory, multistage approach involving literature analysis, stakeholder consensus building, and validation through pretesting and real-world application. Implementation and use of the NMDS serve multiple functions, including documenting nursing care processes, supporting workload measurement and resource planning, quality assurance, benchmarking, and demonstrating nursing's contribution to patient outcomes. However, successful implementation depends on technical, legal, organizational, and educational strategies. Core challenges include a lack of standardized terminology, inconsistent legal frameworks, and varying levels of staff training and acceptance. The NMDS provides a robust basis for standardized nursing documentation, quality assurance, and health system planning, but international variability and ongoing challenges in harmonization, integration, and acceptability persist. Advancing the NMDS requires collaborative efforts for interoperability, investment in digital infrastructure, and targeted education. Further research should focus on comparative effectiveness, cross-context validation, and strategies to reduce documentation burden while maximizing data utility.

Critical electronics used for isotopes production have become outdated and difficult to manufacture. In particular the alpha-particle and neutron detection electronics (commonly referred to as Q2809A-9 and -11) which are used to monitor effluent activity in ORNL Building 7920 were designed and deployed in 1966-67. These electronics are still used but some parts are no longer available for purchase. In addition, the printed circuit boards used in the Count Rate Monitor (CRM) module have no fabrication files or quality assurance documentation. In light of this, a project to modernize the modules for ability to manufacture with modern parts was undertaken. Both the preamplifier and CRM were modernized with new printed circuit boards and parts which are current catalog parts. In addition, QA documentation was generated which allows the manufacturer to assure proper operation prior to delivery.

Robotic laboratory equipment malfunctions may affect the performance of integrated laboratory instruments. Thus, the qualification of robotics is necessary to ensure adequate performance of complete integrated systems. In this JALA Tutorial, we adapt the methods used in production processes to laboratory robotics and propose guidelines for performing the various steps required for qualification (i.e., installation, operational, and performance qualification), while emphasizing specific aspects of laboratory robotics. We think that the application of such guidelines will help in standardizing the acceptance of robotic equipment, facilitate their operation and performance evaluation, and improve traceability with quality assurance documentation.

5.9% of the Austrian population is affected by diabetes mellitus. Disease Management is a structured treatment approach that is suitable for application to the diabetes mellitus area and often is supported by information technology. This article describes the information systems developed and implemented in the Austrian disease management programme for type 2 diabetes. Several workflows for administration as well as for clinical documentation have been implemented utilizing the Austrian e-Health infrastructure. De-identified clinical data is available for creating feedback reports for providers and programme evaluation.

Quality assurance of polyethylene liners

How to build a quality-related documentary system

Canadian family physician knowledge and attitudes toward laboratory utilization management