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. It was easier to be higher up and fit more in frame than to upload heavy amounts of photos.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. Note: Yes, the console was used for some of the screenshots. ![]() For those interested, you can read the story here. The pictures are for clarification concerning the locations I refer to in the story. I've also included a few extra pictures of the islands I have built on up to this point, and have even started a short story based on my first experiences playing the game during the first week (been a while since I've gamed anything, so to go back to gaming on Valheim was really nostalgic). I've mentioned it here on reddit for others, as it has an excellent island for the spawn point. The seed I used for my world is Yggdrasil (the Tree of Life in Norse Mythology), and the topographical arrangement of the world has been nothing short of impressive to me (I love it). I've used this technique to create buildings elevated above the ground, with skirting around it for aesthetics, so that as to avoid the time and energy of grading the land(s)-plus it saves me stone as I don't need to raise the ground near as much having learned to build over it instead. Earlier today I was involved in a discussion wherein I made the point that so long as the beams were impregnated into the ground (meaning the beam, once placed, is to some extent below the ground level), this would act just the same as grading the ground to instead place the flooring.
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