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21 CFR Part 11 compliance and software validation usage in Design Control

Ricky Abreu
Ricky Abreu ✭
edited 12/09/19 inArchived 2016 Posts

I would like to request if there are MED device users to share their experience while working on medical device or pharma projects that are related to new product initiative filings requiring regulatory complaince in closed loop systems integration and security. Have you had to prove part 11 and validation compliance?

Your guidance is appreciated, thanks. Ricky

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Hi, <\/p>

Instead of applying the formula to \"Multiselect Text String\" row, did you tried with \"Multiselect Values\" row?<\/p>

=IF(HAS([Multiselect Values]@row, [Component ID]@row), \"MATCH\", \"NO MATCH\")<\/p>

Thank you,<\/p>"}]}},"status":{"statusID":3,"name":"Accepted","state":"closed","recordType":"discussion","recordSubType":"question"},"bookmarked":false,"unread":false,"category":{"categoryID":322,"name":"Formulas and Functions","url":"https:\/\/community.smartsheet.com\/categories\/formulas-and-functions","allowedDiscussionTypes":[]},"reactions":[{"tagID":3,"urlcode":"Promote","name":"Promote","class":"Positive","hasReacted":false,"reactionValue":5,"count":0},{"tagID":5,"urlcode":"Insightful","name":"Insightful","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":11,"urlcode":"Up","name":"Vote Up","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":13,"urlcode":"Awesome","name":"Awesome","class":"Positive","hasReacted":false,"reactionValue":1,"count":0}],"tags":[]},{"discussionID":109493,"type":"question","name":"I am having trouble using \"And\", \"OR\" & \"Countif(s)\" to build a formula.","excerpt":"Hello, I am attempting to come up with a sheet summary formula that counts cells if they meet at least one of 3 different statuses in the same column, AND also meet one of 5 different statuses in a separate column. So using the screenshot I've provided as an example (although it doesn't have 5 different statuses in the…","snippet":"Hello, I am attempting to come up with a sheet summary formula that counts cells if they meet at least one of 3 different statuses in the same column, AND also meet one of 5…","categoryID":322,"dateInserted":"2023-08-25T20:03:21+00:00","dateUpdated":null,"dateLastComment":"2023-08-26T00:34:49+00:00","insertUserID":165710,"insertUser":{"userID":165710,"name":"SmarsheetNewb","url":"https:\/\/community.smartsheet.com\/profile\/SmarsheetNewb","photoUrl":"https:\/\/us.v-cdn.net\/6031209\/uploads\/defaultavatar\/nWRMFRX6I99I6.jpg","dateLastActive":"2023-08-26T00:33:27+00:00","banned":0,"punished":0,"private":false,"label":"✭"},"updateUserID":null,"lastUserID":161714,"lastUser":{"userID":161714,"name":"Carson Penticuff","url":"https:\/\/community.smartsheet.com\/profile\/Carson%20Penticuff","photoUrl":"https:\/\/us.v-cdn.net\/6031209\/uploads\/userpics\/B0Q390EZX8XK\/nBGT0U1689CN6.jpg","dateLastActive":"2023-08-27T02:16:35+00:00","banned":0,"punished":0,"private":false,"label":"✭✭✭✭✭✭"},"pinned":false,"pinLocation":null,"closed":false,"sink":false,"countComments":3,"countViews":26,"score":null,"hot":3386005690,"url":"https:\/\/community.smartsheet.com\/discussion\/109493\/i-am-having-trouble-using-and-or-countif-s-to-build-a-formula","canonicalUrl":"https:\/\/community.smartsheet.com\/discussion\/109493\/i-am-having-trouble-using-and-or-countif-s-to-build-a-formula","format":"Rich","tagIDs":[254],"lastPost":{"discussionID":109493,"commentID":392692,"name":"Re: I am having trouble using \"And\", \"OR\" & \"Countif(s)\" to build a formula.","url":"https:\/\/community.smartsheet.com\/discussion\/comment\/392692#Comment_392692","dateInserted":"2023-08-26T00:34:49+00:00","insertUserID":161714,"insertUser":{"userID":161714,"name":"Carson Penticuff","url":"https:\/\/community.smartsheet.com\/profile\/Carson%20Penticuff","photoUrl":"https:\/\/us.v-cdn.net\/6031209\/uploads\/userpics\/B0Q390EZX8XK\/nBGT0U1689CN6.jpg","dateLastActive":"2023-08-27T02:16:35+00:00","banned":0,"punished":0,"private":false,"label":"✭✭✭✭✭✭"}},"breadcrumbs":[{"name":"Home","url":"https:\/\/community.smartsheet.com\/"},{"name":"Get Help","url":"https:\/\/community.smartsheet.com\/categories\/get-help"},{"name":"Formulas and Functions","url":"https:\/\/community.smartsheet.com\/categories\/formulas-and-functions"}],"groupID":null,"statusID":3,"attributes":{"question":{"status":"accepted","dateAccepted":"2023-08-26T00:33:25+00:00","dateAnswered":"2023-08-25T20:44:12+00:00","acceptedAnswers":[{"commentID":392662,"body":"

Try this:<\/p>

=COUNTIFS([Item Number]:[Item Number], OR(@cell = \"C001\", @cell = \"COO2\", @cell = \"COO3\", @cell = \"COO4\"), [Status]:[Status], OR(@cell = \"Green\", @cell = \"Yellow\", @cell = \"Red\"))<\/p>"}]}},"status":{"statusID":3,"name":"Accepted","state":"closed","recordType":"discussion","recordSubType":"question"},"bookmarked":false,"unread":false,"category":{"categoryID":322,"name":"Formulas and Functions","url":"https:\/\/community.smartsheet.com\/categories\/formulas-and-functions","allowedDiscussionTypes":[]},"reactions":[{"tagID":3,"urlcode":"Promote","name":"Promote","class":"Positive","hasReacted":false,"reactionValue":5,"count":0},{"tagID":5,"urlcode":"Insightful","name":"Insightful","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":11,"urlcode":"Up","name":"Vote Up","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":13,"urlcode":"Awesome","name":"Awesome","class":"Positive","hasReacted":false,"reactionValue":1,"count":0}],"tags":[{"tagID":254,"urlcode":"formulas","name":"Formulas"}]},{"discussionID":109500,"type":"question","name":"Auto-populate emails on a \"contact list\" column","excerpt":"I have a Form created for internal employees where they can submit request tickets to my department. We all have an account with Smartsheet. One of our columns (\"Requestor Name\") is in the Form where they type in their names. The \"Requestor Name\" column is a Contac List column. My issue here is, how can I have Smartsheet…","snippet":"I have a Form created for internal employees where they can submit request tickets to my department. We all have an account with Smartsheet. One of our columns (\"Requestor Name\")…","categoryID":321,"dateInserted":"2023-08-25T21:43:36+00:00","dateUpdated":"2023-08-25T21:44:14+00:00","dateLastComment":"2023-08-25T22:14:15+00:00","insertUserID":164850,"insertUser":{"userID":164850,"name":"ocanel","title":"Analyst","url":"https:\/\/community.smartsheet.com\/profile\/ocanel","photoUrl":"https:\/\/us.v-cdn.net\/6031209\/uploads\/defaultavatar\/nWRMFRX6I99I6.jpg","dateLastActive":"2023-08-27T06:55:05+00:00","banned":0,"punished":0,"private":false,"label":"✭"},"updateUserID":164850,"lastUserID":165374,"lastUser":{"userID":165374,"name":"Shanky Paul","title":"Project Manager","url":"https:\/\/community.smartsheet.com\/profile\/Shanky%20Paul","photoUrl":"https:\/\/lh3.googleusercontent.com\/a\/AAcHTtcAdE60g-MBEj1rR28GVz9zn6RmbZsmEQm5EiEV=s96-c","dateLastActive":"2023-08-27T08:29:18+00:00","banned":0,"punished":0,"private":false,"label":"✭✭"},"pinned":false,"pinLocation":null,"closed":false,"sink":false,"countComments":1,"countViews":25,"score":null,"hot":3386002071,"url":"https:\/\/community.smartsheet.com\/discussion\/109500\/auto-populate-emails-on-a-contact-list-column","canonicalUrl":"https:\/\/community.smartsheet.com\/discussion\/109500\/auto-populate-emails-on-a-contact-list-column","format":"Rich","tagIDs":[204,247,334,448,527],"lastPost":{"discussionID":109500,"commentID":392677,"name":"Re: Auto-populate emails on a \"contact list\" column","url":"https:\/\/community.smartsheet.com\/discussion\/comment\/392677#Comment_392677","dateInserted":"2023-08-25T22:14:15+00:00","insertUserID":165374,"insertUser":{"userID":165374,"name":"Shanky Paul","title":"Project Manager","url":"https:\/\/community.smartsheet.com\/profile\/Shanky%20Paul","photoUrl":"https:\/\/lh3.googleusercontent.com\/a\/AAcHTtcAdE60g-MBEj1rR28GVz9zn6RmbZsmEQm5EiEV=s96-c","dateLastActive":"2023-08-27T08:29:18+00:00","banned":0,"punished":0,"private":false,"label":"✭✭"}},"breadcrumbs":[{"name":"Home","url":"https:\/\/community.smartsheet.com\/"},{"name":"Get Help","url":"https:\/\/community.smartsheet.com\/categories\/get-help"},{"name":"Smartsheet Basics","url":"https:\/\/community.smartsheet.com\/categories\/smartsheet-basics%2B"}],"groupID":null,"statusID":3,"attributes":{"question":{"status":"accepted","dateAccepted":"2023-08-27T06:55:03+00:00","dateAnswered":"2023-08-25T22:14:15+00:00","acceptedAnswers":[{"commentID":392677,"body":"

Hi, <\/p>

Add a \"Created By\" column in your sheet and turn on \"Required smartsheet login to access your form\" in your form setting. So that whoever fills out the form, their email id will be automatically captured in \"created by\" column. This will replace your \"Requestor Name\" column. <\/p>

Thank you!<\/p>


<\/p>

\n
\n \n \"Screen<\/img><\/a>\n <\/div>\n<\/div>\n
\n
\n \n \"Screen<\/img><\/a>\n <\/div>\n<\/div>\n


<\/p>"}]}},"status":{"statusID":3,"name":"Accepted","state":"closed","recordType":"discussion","recordSubType":"question"},"bookmarked":false,"unread":false,"category":{"categoryID":321,"name":"Smartsheet Basics","url":"https:\/\/community.smartsheet.com\/categories\/smartsheet-basics%2B","allowedDiscussionTypes":[]},"reactions":[{"tagID":3,"urlcode":"Promote","name":"Promote","class":"Positive","hasReacted":false,"reactionValue":5,"count":0},{"tagID":5,"urlcode":"Insightful","name":"Insightful","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":11,"urlcode":"Up","name":"Vote Up","class":"Positive","hasReacted":false,"reactionValue":1,"count":0},{"tagID":13,"urlcode":"Awesome","name":"Awesome","class":"Positive","hasReacted":false,"reactionValue":1,"count":0}],"tags":[{"tagID":204,"urlcode":"forms","name":"Forms"},{"tagID":247,"urlcode":"contacts","name":"Contacts"},{"tagID":334,"urlcode":"automations","name":"Automations"},{"tagID":448,"urlcode":"workflows-in-smartsheet","name":"Workflows in Smartsheet"},{"tagID":527,"urlcode":"columns","name":"columns"}]}],"initialPaging":{"nextURL":"https:\/\/community.smartsheet.com\/api\/v2\/discussions?page=2&includeChildCategories=1&type%5B0%5D=Question&excludeHiddenCategories=1&siteSectionID=0&sort=-hot&limit=3&expand%5B0%5D=all&expand%5B1%5D=-body&expand%5B2%5D=insertUser&expand%5B3%5D=lastUser&status=accepted","prevURL":null,"currentPage":1,"total":10000,"limit":3},"title":"Trending Posts","subtitle":null,"description":null,"noCheckboxes":true,"containerOptions":[],"discussionOptions":[]}">

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