1. Q

    Signatures on C of Cs (Certificate of Conformity)

    All, We are a contract manufacturer of PCBAs. One of our customers reviewed some of our quality records and documents for one of their assemblies and noticed that a C of C we received for components from an authorized distributor did not have the "requisite" signature. Most if not all of...
  2. 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...
  3. J

    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...
  4. N

    Original signed IQ/OQ/PQ missing - but have data - Do we do it over?

    Hi All - During an audit, I found that our IQ/OQ/PQ report for moving a machine from one side of the facility to the other was missing all the approval signatures. The IQ/OQ/PQ was done in 2011. I have the template still filled in with all of the data. But I can not find the...
  5. 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...
  6. B

    Quality Records - Should any record be signed?

    Hi I have a question about quality records. we are register to ISO 13458 and ISO 9001. Should any record be signed? We don't have an electronic signature. If I want to save purchase order from the ERP should it be signed? or can I keep it in the computer without signature? Thanks in advance
  7. T

    Stamps vs Signatures - Stamps as inspection/approval sign-off vs. Initials

    I am new to the company I work for and have learned that some of our divisions use stamps as inspection/approval sign-off while others use initials/signature. I would like to get every division using the same system. I would like to solicit your input on the pro's and con's of stamps vs...
  8. R

    Wet Signature Document Attachments in SAP - Risk on Data Integrity issue?

    is wet signature document that is uploaded to SAP Notification considered to be at risk on Data Integrity issue? is this common practice in Pharma industry. any comments would be appreciated. Thanks.
  9. Printerman

    Document Control - Do hard copies of documents need to be signed?

    Hi i have a question regarding the above. Do hard copies of documents actually need to be signed? My old employer never did this and i was never pulled up about it by an auditor. My new employer does do this but its a pain with signing, scanning etc... I'm thinking if i am the...
  10. B

    Does Anyone utilize MS Outlook Read Receipts

    as records? Scenario: a minor revision(s) to an SOP in which mostly remote co-workers involved need to know about the revision, but re-training is not required. An Outlook delivery receipt confirms delivery - but - not that the recipient has read or seen the message. A read receipt confirms...
  11. Q

    Does ISO 9001 Requirement for Document Approval (a service organization)

    Hi, I work in a small ISO 9001 service organization that generates a lot of specs and plans that require customer approval. I'm getting a lot of push-back on implementing a requirement for customer 'wet' signatures of all specs and plans calling for customer approval. My previous history...
  12. G

    Procedure to define Signing Authority for Procurement Limits

    Hi folks, For medical devices do I need a procedure to define signing authority for procurement limits then also for QMS activities such as document approvals, records, contracts, DHR, etc. I've seen very simple examples of an approval matrix but not sure if it should cover purchasing...
  13. S

    Should we get Quality Policy re-signed if the signatories leave?

    Our Quality Policy is signed by the CEO and the VP-Quality Assurance. We now have a situation where the VP-Quality Assurance has resigned and a new VP is in place. Should we have our Quality Policy re-signed by CEO and the new VP or we could stick with the Policy and train the new VP to the...
  14. D

    Anyone Practicing Approval Signatures on Every Page of a Doc?

    I am confused as to whether or not approval signature(s) must be on every page of a document in an facility under ISO 13485 and 21 CFR. There is no requirement in either regulation but I know of someone whom said they mediated between FDA and a company - the company made approval signatures on...
  15. S

    Clinical Trial Informed Consent Forms ("retro-signing")

    Hello, Is there any action which might be taken in order not to lose participants who inappropriately signed the ICF? Maybe having the participant sign on a statement stating he/she fully understood the content of the ICF and are willing to allow the trial team use the data collected on them...
  16. R

    Questions about editing a form because no one is signing it.

    Hi all, first time questioner here, so please do inform me if there's anything I should do differently. I have a question about a specific form we're using, but it affects our QMS as a whole, if this ever comes up again. As far as background, we are in the process of becoming ISO 9001...
  17. T

    Test Report - Customer Signature - Customer did not witness test

    Our customer - an inspection body - brought a sample to be tested. he didn't witness or perform any kind of testing, but he is requesting to sign the test report under the title "Third Party Inspection". is it ok if we made him do that? what other solution you may suggest. thanks
  18. L

    Must the Signature on a Quality Record be Legible?

    Simple question I suppose, but when a signature is part of a quality record must the signature be legible? Section 4.2.4 of ISO 9001-2008 says quality records must be legible, and I have always taken that to include the signature, but I wanted to see if this is more of my own pet peeve or do...
  19. D

    FDA required (mandatory) Signed Records

    Hello, We are a medical device manufacturer and we are going to submit o 510k for our device. Until now, we are a using a document management tool to store our documents and an issue management tool to handle CAPAs, non conformities and complaints. Because these tools are not 21 cfr 11...
  20. D

    21 CFR 11 Tools Validation - Electronic Document and Records Control

    Hello, We are a small medical manufacturer company (<50 employees) and our plan is to get FDA approval of our product. We are using open source tools for document management (Alfresco) and for issue tracking (Redmine and JIRA). In order to comply with the requirements of 21 cfr 11, we have...