Regulatory Compliance and Quality Assurance-II

2006 ◽  
Vol 31 (1) ◽  
pp. 8-10
Author(s):  
Arif Subhan
Keyword(s):  
Quality Assurance ◽  
Regulatory Compliance

scholarly journals Implementation of and experiences with new automation

2000 ◽  
Vol 22 (6) ◽  
pp. 199-202 ◽  
Author(s):  
Ifte Mahmud ◽  
David Kim
Keyword(s):  
Quality Assurance ◽  
Implementation Process ◽  
Regulatory Compliance ◽  
Contributing Factors ◽  
The Future ◽  
Industry Automation ◽  
High Level ◽  
Automation Technology ◽  
And Robotics ◽  
Testing Group

In an environment where cost, timeliness, and quality drives the business, it is essential to look for answers in technology where these challenges can be met. In the Novartis Pharmaceutical Quality Assurance Department, automation and robotics have become just the tools to meet these challenges. Although automation is a relatively new concept in our department, we have fully embraced it within just a few years. As our company went through a merger, there was a significant reduction in the workforce within the Quality Assurance Department through voluntary and involuntary separations. However the workload remained constant or in some cases actually increased. So even with reduction in laboratory personnel, we were challenged internally and from the headquarters in Basle to improve productivity while maintaining integrity in quality testing. Benchmark studies indicated the Suffern site to be the choice manufacturing site above other facilities. This is attributed to the Suffern facility employees' commitment to reduce cycle time, improve efficiency, and maintain high level of regulatory compliance. One of the stronger contributing factors was automation technology in the laboratoriess, and this technology will continue to help the site's status in the future. The Automation Group was originally formed about 2 years ago to meet the demands of high quality assurance testing throughput needs and to bring our testing group up to standard with the industry. Automation began with only two people in the group and now we have three people who are the next generation automation scientists. Even with such a small staff,we have made great strides in laboratory automation as we have worked extensively with each piece of equipment brought in. The implementation process of each project was often difficult because the second generation automation group came from the laboratory and without much automation experience. However, with the involvement from the users at ‘get-go’, we were able to successfully bring in many automation technologies. Our first experience with automation was SFA/SDAS, and then Zymark TPWII followed by Zymark Multi-dose. The future of product testing lies in automation, and we shall continue to explore the possibilities of improving the testing methodologies so that the chemists will be less burdened with repetitive and mundane daily tasks and be more focused on bringing quality into our products.

Practical Quality Improvement Applied to Toxicology Studies

1991 ◽  
Vol 10 (3) ◽  
pp. 387-391
Author(s):  
A. W. Waddell
Keyword(s):  
Quality Assurance ◽  
Quality Improvement ◽  
Cost Effectiveness ◽  
Regulatory Compliance ◽  
Good Laboratory Practice ◽  
Quality Assurance Program ◽  
Laboratory Practice ◽  
Good Laboratory ◽  
The Cost

Elements that are required for regulatory compliance can be used as powerful resources to achieve quality improvement. One such approach, using the output from a Good Laboratory Practice quality assurance program, is described and has produced marked improvements in the conduct and reporting of toxicology studies. The cost effectiveness of quality assurance programs under such circumstances is discussed.

scholarly journals Gap-analysis of DNA barcoding in ERMS reference libraries for ascidians and cnidarians

2020 ◽  
Author(s):  
Guy Paz ◽  
Baruch Rinkevich
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Dna Barcoding ◽  
Regulatory Compliance ◽  
Marine Biodiversity ◽  
Sequence Information ◽  
Reference Library ◽  
Knowledge Gaps ◽  
Ecosystem Monitoring ◽  
Wide Range

Abstract BackgroundAll-inclusive DNA barcoding libraries in the storage and analysis platform of the BOLD (Barcode of Life Data) system are essential for the study of the marine biodiversity and are pertinent for regulatory purposes, including ecosystem monitoring and assessment, such as in the context of the EU Water Framework Directive (WFD) and the Marine Strategy Framework Directive (MSFD). Here we investigate knowledge gaps in the lists of DNA barcoded organisms within two inventories, Cnidaria (Anthozoa and Hydrozoa) and Ascidiacea from the reference libraries of the European Register of Marine Species (ERMS) dataset (402 ascidians and 1200 cnidarian species). ERMS records were checked species by species, against publicly available sequence information and other data stored in BOLD system. As the available COI barcode data adequately covers just a small fraction of the ERMS reference library, it is of importance to employ quality control on existing data, to close the knowledge gaps and purge errors off BOLD.ResultsResults revealed that just 22.9% and 29.2% of the listed ascidians and cnidarians species, respectively, are BOLD barcodes of which, 58.4% and 52.3% of the seemingly barcoded species, respectively, were noted to have complete BOLD pages. Thus, only 11.44% of the tunicate and 17.07% of the cnidarian data in the ERMS lists are of high quality. Deep analyses revealed seven common types of gaps in the list of the barcoded species in addition to a wide range of discrepancies and misidentifications, discordances and errors primarily in the GenBank mined data as with the BINs assignments, among others.ConclusionsGap knowledge in barcoding of important taxonomic marine groups exist and in addition, quality management elements (quality assurance and quality control) were not employed when using the list for national monitoring projects, for regulatory compliance purposes and other purposes. Even though BOLD is the most trustable DNA barcoding reference library, worldwide projects of DNA barcoding are needed to close these gaps of mistakes, verifications, missing data and unreliable sequencing labs. Tight quality control and quality assurance is important to close the knowledge gaps of Barcoding of the European recommended ERMS reference library.

scholarly journals Gap analysis of DNA barcoding in ERMS reference libraries for ascidians and cnidarians

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Guy Paz ◽  
Baruch Rinkevich
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Dna Barcoding ◽  
Regulatory Compliance ◽  
Marine Biodiversity ◽  
Sequence Information ◽  
Reference Library ◽  
Knowledge Gaps ◽  
Ecosystem Monitoring ◽  
Wide Range

Abstract Background All-inclusive DNA-barcoding libraries in the storage and analysis platform of the BOLD (Barcode of Life Data) system are essential for the study of the marine biodiversity and are pertinent for regulatory purposes, including ecosystem monitoring and assessment, such as in the context of the EU Water Framework Directive (WFD) and the Marine Strategy Framework Directive (MSFD). Here, we investigate knowledge gaps in the lists of DNA barcoded organisms within two inventories, Cnidaria (Anthozoa and Hydrozoa) and Ascidiacea from the reference libraries of the European Register of Marine Species (ERMS) dataset (402 ascidians and 1200 cnidarian species). ERMS records were checked species by species, against publicly available sequence information and other data stored in BOLD system. As the available COI barcode data adequately cover just a small fraction of the ERMS reference library, it is of importance to employ quality control on existing data, to close the knowledge gaps and purge errors off BOLD. Results Results revealed that just 22.9% and 29.2% of the listed ascidians and cnidarians species, respectively, are BOLD barcodes of which 58.4% and 52.3% of the seemingly barcoded species, respectively, were noted to have complete BOLD pages. Thus, only 11.44% of the tunicate and 17.07% of the cnidarian data in the ERMS lists are of high quality. Deep analyses revealed seven common types of gaps in the list of the barcoded species in addition to a wide range of discrepancies and misidentifications, discordances, and errors primarily in the GenBank mined data as with the BINs assignments, among others. Conclusions Gap knowledge in barcoding of important taxonomic marine groups exists, and in addition, quality management elements (quality assurance and quality control) were not employed when using the list for national monitoring projects, for regulatory compliance purposes and other purposes. Even though BOLD is the most trustable DNA-barcoding reference library, worldwide projects of DNA barcoding are needed to close these gaps of mistakes, verifications, missing data, and unreliable sequencing labs. Tight quality control and quality assurance are important to close the knowledge gaps of Barcoding of the European recommended ERMS reference library.

scholarly journals Benchmarking as an Instrument for Continuous Improvement in a Regulated Higher Education Quality Assurance Environment

2018 ◽  
pp. 35-73 ◽  
Author(s):  
Fernando F. Padró ◽  
Michael Sankey
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Good Practice ◽  
Performance Standards ◽  
Regulatory Compliance ◽  
Leadership Role ◽  
Education Quality ◽  
Technology Enhanced Learning ◽  
Higher Education Quality ◽  
Education Quality Assurance

Benchmarking by higher education institutions (HEIs) has been evolving for some time in Australia and New Zealand. Earlier efforts were focused on improving reputation, but now benchmarking has become a required component of higher education quality assurance, or regulatory compliance schemes. ACODE's benchmarking framework and the ACODE Benchmarks provide Australasian HEIs with the ability to review their technology enhanced learning (TEL) practices and decision-making against what is considered “good” practice. The ACODE benchmarking framework and its benchmarks also allow HEIs to inform quality audit, or regulatory compliance reporting by HEIs to maintain institutional recognition and demonstrate performance against threshold or other specific performance standards. ACODE's benchmarking framework and benchmarks are recognized as influencers in benchmarking practice. However, there is a need to generate empirical data to demonstrate its leadership role and review the benchmarks for present purposes and to determine how they are used by HEIs. Thus, in effect, this case study represents a view of the increasing importance of benchmarking in higher education quality assurance schemes—at least in some national sectors—through the lens of benchmarking the benchmarks. The case presents the ongoing efforts, providing available data from one completed round and a still to be completed second round of what has become a biennial exercise. Findings so far suggest increasing interest in using the ACODE benchmarks to assist in determining performance within HEI TEL-related issues and in HEI participation in the benchmarking the benchmarks exercise as a means of learning from each other's practice.

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