Integrity plus auto4/14/2023 Although in GLP we like to talk about reproducibility (a hold-over from our analytical backgrounds, perhaps?), we very rarely have the need to reproduce a GLP study but very often reconstruct them. We need to have enough evidence to be able to reconstruct 4 Notice I’m not using ‘reproduce’ here. ![]() For GLP studies and GCP trials, the product is the final report and we measure its quality in terms of the data supporting the report’s conclusions. You might measure software quality in terms of test coverage or defects per line of code. In a physical product such as pharmaceuticals or medical devices, the measure of product quality might be in meeting a specification, or in statistical terms such as the number of defects per batch. Consequently we as a society have decided that we require evidence to support that quality. Whether you’re working with non-clinical safety studies, clinical trials, pharmaceutical production, forensics, air traffic control software or medical devices, your product’s quality is directly linked to public safety. Though much of the context I’ll give comes from a GLP perspective, it will be applicable to quality systems in general. Then we’re going to explore each of the nine aspects of ALCOA+ in detail with a few illustrative (if not always realistic) examples to help us on our way. In this article we’re going to take a deep dive into ALCOA+, starting with what the regulations and guidance have to say on the topic. We commonly refer to this extended concept as ALCOA+.Ĥ Conclusion: ALCOA+ by Design Introduction This highlights data management requirements that were somewhat implicit in the original five. ![]() The European Medicines Agency (EMA) added another four items to round out the concept: Complete, Consistent, Enduring and Available 3 I believe it was in the 2010 “ Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials”, though I have no evidence that this was the first use of ALCOACCEA. ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. Woollen of the FDA’s Office of Enforcement in the 1990s 2 He tells the story of how it came to be in this SRCSQA newsletter article. Integrity Plus Autobody Collision and Specialties LLC is located at 6137 Enterprise Parkway Grove City, Ohio 43123.ALCOA is and mnemonic device 1 Wikipedia: A mnemonic device, or memory device, is any learning technique that aids information retention or retrieval in the human memory for the elements of data quality, particularly with respect to its use as evidence of regulatory compliance. This ensures a timely, quality oriented repair that we can be proud to put our name on. We work together with all insurance companies, always keeping our customers best interests in mind. Always providing them with Honesty, Craftmenship, Quality and Value, our goal, to serve our community with the highest standard of Excellence possible. The staff at Integrity Plus Autobody promises to address the individual needs of our customers. We also offer a full line of customizing and refinishing options, so regardless of the vehicle you may own or the type of repair needed Integrity Plus is put into every job. We are confident that your vehicle will be restored to it's pre-accident condition, and we W arranty it for as long as you own your car. Integrity Plus offers the most up to date computerized equipmentavailable combined with Automotive Service Excellence, (ASE) certified technicians. ![]() Small and personal, we feature 32 years of unriveled craftsmanship and experience in the autobody repair and refinishing industry. Integrity Plus Autobody Collision and Specialties LLC is a family owned and operated state of the art autobody collision repair facility.
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