tarak_desai ☆ India, 2017-04-06 11:46 (2548 d 04:25 ago) Posting: # 17230 Views: 3,166 |
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Hello to all, Can anyone share regulatory guidance on spreadsheet validation? I have few questions and need guidance on it. who should do spreadsheet validation? user department or QA ? what should be role of user department and QA in spreadsheet validation in GCP environment? what all validation document required? Do we need to validate dose calculation sheet for clinical study? Thanks in advance Tarak |
ElMaestro ★★★ Denmark, 2017-04-06 20:47 (2547 d 19:25 ago) @ tarak_desai Posting: # 17231 Views: 2,703 |
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Hi tarak, in the early days of spreadsheets a few issues were identified (e.g. in relation to SD calculation for non.biological data) which caused some people to conclude that all spreadsheets are useless etc. There are many nuances. Like you I also believe spreadsheets have their place and most of the early issues have been well weeded out, not least because of opensource spreadsheets that had safer calculations. ❝ who should do spreadsheet validation? user department or QA ? As per your SOP. May be your clinical department, your metrology department, IT, or someone else. ❝ what should be role of user department and QA in spreadsheet validation in GCP environment? ❝ what all validation document required? What di you mean here? ❝ Do we need to validate dose calculation sheet for clinical study? Of course not, unless you think the dose somehow is important in relation to safety, efficacy or the subject's well-being. — Pass or fail! ElMaestro |
Helmut ★★★ Vienna, Austria, 2017-04-09 23:32 (2544 d 16:39 ago) @ tarak_desai Posting: # 17234 Views: 2,633 |
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Hi Tarak, ❝ Can anyone share regulatory guidance on spreadsheet validation? I’m not aware of any one specific for spreadsheets. For computerised systems the EMA’s GCP Inspectors Working Group recommended the guidelines issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Navigate to Publications and have fun with PI 011-3. ❝ Do we need to validate dose calculation sheet for clinical study? Sure! Dose is to most important independent parameter in PK. Otherwise you may end up with something like in this case. As an appetizer see Esch et al.* No, it is neither fun nor easy to do.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
vish14184 ★ India, 2017-04-16 22:56 (2537 d 17:15 ago) @ tarak_desai Posting: # 17242 Views: 2,510 |
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Dear tarak, refer below link of guidance for spreadsheet validation. https://www.fda.gov/scienceresearch/fieldscience/laboratorymanual/ucm174286.htm#4_5_2 first prepare validation protocol or SOP and define responsibility of validation team (IT, user department and QA), validation strategy depending on risk assessment and it's security. According to SOP/protocol execute validation activities. With Regards Vishal Nakrani |