{"id":812976,"date":"2020-07-08T10:10:42","date_gmt":"2020-07-08T08:10:42","guid":{"rendered":"https:\/\/biotrading.com\/?p=812976"},"modified":"2024-07-15T10:10:56","modified_gmt":"2024-07-15T08:10:56","slug":"data-availability","status":"publish","type":"post","link":"https:\/\/biotrading.com\/nl\/data-availability\/","title":{"rendered":"Data Availability"},"content":{"rendered":"\n

The last concept added to the ALCOA+\nprinciple is Data Availability<\/strong>.<\/p>\n\n\n\n

This point is a consequence of the previous one (Data\nEndurance), i.e. data must not only exist, it must also be accessible whenever\nneeded, during the whole data lifecycle.<\/p>\n\n\n\n

Availability ensures data meets its use, since it can\nbe used when needed. Data should be accessible at any time during the required\nlifetime. This also applies to any associated metadata. Additionally, data must\nbe made available, securely, for the people who need it. Undoubtedly, the most\nefficient way to achieve the availability principle is recording data\nelectronically.<\/p>\n\n\n\n

Let\u2019s look at an example of an FDA warning letter to\nbetter explain how the Availability concept should be applied to pharmaceutical\ncompanies:<\/p>\n\n\n\n

FDA Warning Letter 320-19-16 (March 2019)<\/a><\/strong><\/p>\n\n\n\n

Your firm failed to ensure that laboratory\nrecords included complete data derived from all tests necessary to ensure\ncompliance with established specifications and standards (21 CFR 211.194(a)).<\/em><\/strong><\/p>\n\n\n\n

You do not retain laboratory data\ngenerated by your analysts<\/em>. During our inspection, your staff\ntold our investigator that your firm\u2019s laboratory worksheets contain only final\nlaboratory results. You do not retain records of sample\nweights written on paper<\/em>. The papers are discarded after your\nstaff performs calculations.<\/p>\n\n\n\n

Due to your failure to retain laboratory\ndata, our investigator was unable to confirm the validity of your results.\nYou could not provide any rationale for failing to maintain the complete data.\nYour staff further stated to our investigator that if a sample preparation is\nnot good, it is thrown away and restarted. The staff does not retain that data.<\/em><\/p>\n\n\n\n

In response to this letter, provide:<\/em><\/p>\n\n\n\n