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electronic signatures and approvals

  1. S

    How to make Single Sign On (SSO) Comply e-sig requirements?

    We have a training software that is part of multiple but independent software systems operating on Single Sign-On (SSO) access controls. In the training software, the trainee "reads and understands" the procedure. With the SSO in place, the trainee need not use his user name and password to...
  2. S

    Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant?

    Hi everyone, I would like clarification on the use of Adobe Sign to electronically sign QMS documents that is also 21 cfr part 11 compliant. Does anyone have experience with this? The link is this: Adobe Sign for Microsoft - Word/PowerPoint Add-in E-sign documents online, secure e-signature...
  3. S

    Paper-based QMS

    If a company stores only soft copies on its controlled server without printing out hard copies (to reduce the amount of paper to be printed), is it still considered a paper-based QMS? What is the best way to get approvals for such a system? Are digital signatures in compliance with 21 CFR Part...
  4. C

    Signature manifestations - 21 CFR Part 11

    Hi everyone, according to 21 CFR Part 11, timestamp, name of signee and meaning of an electronic signature has to be included as part of "any human readable form" of the record, including electronic display. I have had a look at several EDC systems recently and some of them only display a...
  5. M

    Electronic signature - name.lastname or equal to handwritten

    It´s ok to have only the name and the last name of the signer (and of course other information needed like hour, date...) or it needs to be equivalent handwritten signature... What im trying to understand is... If i have some document only with my name Micheli Lermen printed... it will be...
  6. M

    Electronic Signature - Certificate

    Dears, Thinking about the need for a digital signature you think it´s necessary for which situations? I mean, If I have a good audit trail and controls like: - confirmation - user and password - before approve/sign a document - the signature responsible, hour and date...
  7. I

    GMP 21 CFR Part 11 Electronic Records Compliance Project Help

    Hello World, I work in QA at a small biologics manufacturer and have been assigned to lead a 21 CFR Part 11 compliance project. I was told that I would need to create User Requirement Specification documents for our LIMS, QMS, analytical equipment and spreadsheets. Do I write the URSs per...
  8. M

    Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)

    Can anyone suggest a software solution for applying FDA CFR Part 11 compliant electronic signatures that: 1. Is simple to implement; and 2. Isn't going to break the bank. We're a small organization (< 10), however, people are often travelling or otherwise unavailable for handwritten...
  9. L

    Part 11 Certified to legally binding of hand written signatures

    My company is implementing Part 11, for the requirement of clause of 11.100c, persons using electronic signature, shall be cerified for legally binding equivalent of traditional handwritten signatures. is there a requirement for this re-certification on annual basis. As we are seeing some of...
  10. S

    Imaged signature is it Ok?

    Hello Dear fellows, I am organizing my internal & external claims reports . my routine of handling the claims documentation is to have a soft copy of the final report sent to customer on my drive (and I usually use picture of my own signature and company stamp I use cropped from the original...
  11. JoshuaFroud

    Addressing wet ink signatures when more than one site is involved

    Hi All First post here after lurking for a number of years. I have recently moved to a new job at a much smaller and less mature company and I am currently the only Quality Professional, due to this being asked a lot of "can we...." questions. Today's question I have not been able to...
  12. T

    Requirement of signatures anywhere in IATF ?

    Good morning, is there a shall in IATF in regards of certain documents needing signatures? I went thru the book and didn't see anything. We are trying to go paper less as much as possible, and set up electronic signatures for certain documents. I've identified myself what forms that...
  13. D

    21 CFR Part 11 - Electronic Signature Management SOP

    Anyone has an example of SOP to manage the electronic signature requirements in compliance with 21 CFR Part 11: in particular education and training 11.10(i)) and policy for use electroni signatures 11.10(j)?:thanks:
  14. G

    Auto electronic signature on Calibration Form

    We are working toward ISO 9xxx, but no audits or anything yet. We do some calibration for customers and issue a calibration certificate (in ISO 17025 format). We have the tech sign it , but the final check is done by a fellow that does not want to actually sign anything and the form always...
  15. V

    Use of e-records and e-Signatures in Clinical Investigations Under 21 CFR part 11 Q&A

    quick outline from first view., ER/ES for Clinical Investigations - Q&As ... Key points. ELECTRONIC SYSTEMS.... Electronic systems, including commercial off-the-shelf (COTS) and customized electronic systems owned or managed by sponsors and other regulated entities Electronic services...
  16. Z

    SAP Validation for Part 11 Compliance - Examples (executed protocols)

    Hello folks! Would someone be kind enough to share examples of executed protocols of SAP Validation for part 11 compliance. GAMP5 would be ideal but other will be helpful too. Thanks
  17. Q

    How to apply 21 CFR Part 11 and/or cGMP in the Life Sciences industry

    I work as the quality engineer for a fairly small service provider with many of our customers in the Life Sciences industry. Essentially what is provided by my Company is the system (Hardware & Software) that controls and automates the flows of material through valves, actuators and other...
  18. P

    Clarification for 21 CFR Part 11.100 - General Requirements

    I have been reviewing 21 CFR 11 requirements and feel stumped by section 11.100 - General Requirements (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization establishes, assigns, certifies, or...
  19. K

    21 CFR Part 11 (and EU) compliant Digital Signatures on a Production Line

    Hello, I have spent many hours reading around the subject of digital signatures and still do not have a good solution for implementing digital signatures in a medical device company that complies with FDA and EU regulation. My reading has included the thread on the Cove. My most recent...
  20. M

    Has anyone had their electronic system scrutinized in an FDA inspection?

    Hoping people can share how they handle electronic signatures, and more generally electronic systems access. Is there one system administrator with complete control? ...or are administration rights compartmentalized somehow to ensure security? Presently, for our (simplistic) system, we have a...
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