document control

  1. M

    Document Control - Revision Number in Document Names

    Hi, We currently use a document naming system whereby the document revision is included in a file name. While this is useful we are finding problems when we reference or link to documents because when they are updated the links break or the references are invalid. I'd be interested to know...
  2. T

    QMS - Documentation Cloud Storage

    Hi All, An organization using a cloud storage system for QMS documentation storing and easy access in everywhere (motive of save paper work). Is there any special requirements available or need to comply in this case like security/hacking related? Also this cloud storage system required...
  3. W

    Is it required to stamp obsolete hard copy DHR's "obsolete"?

    Question? Is it required to stamp hard copy DHR's "obsolete"
  4. I

    R&D prototype documents need to be controlled?

    I had a question from someone about when we need to start controlling documents. For example if you're writing a document that has a new idea for a prototype, and you want other team members to be able to view and collaborate on the document, do you put the document in a controlled environment...
  5. I

    First Time Implementing Document Control for ISO-9001 - how far back do you go?

    If you are starting document control for a company that did not use it before, how do you address years worth of documents (hundreds of them) they weren't approved and released properly? The time to do re-approve and release them would be prohibitive.
  6. I

    Document Control Workflow

    I'm currently looking at a process where I let employees update a document (MS Word, Excel, etc.) - then store them in a review folder, then I send them for e-signature and they come back as a PDF. All good, I publish the PDF file, but then next time they need to make a change I need to have...
  7. I

    Document Signature Software? (Certificate Authorities)

    Does anyone have a preferred digital signature solution for your document approval process? I want to get one installed to I can start having our team apply valid digital signatures to documents. The current process of just adding the signature line in MS Word still returns an error indicating...
  8. C

    Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update?

    Good Morning! We have almost everything completed in our ISO folder for our upcoming audit next month. My questions is do we need to make a new OFI for each document/form we update in our ISO folder? Ex: we updated our recruiting and on-boarding checklist, do we need to make an OFI for this or...
  9. J

    Control of Medical Device Marketing and Promotional Materials - EU regulation

    Does anyone know EU specific guidance or regulation specific to the control of marketing and promotional materials for medical devices? Thanks!
  10. I

    Document levels and approval requirements for lower level documents like work instructions, forms etc.

    I'm looking at a current document control system (manual) and the higher level documents (SOPs) all require approval, but as I go into the lower level documents like work instructions, forms etc. I see that do they don't have approvals for those individual documents. Is this normal?
  11. I

    Data Backup Plan - Document Reference

    This might be getting a bit into the weeds on document control, but I work for a company which is comprised of several sub-entities (formerly their own companies) and the data backup strategy that we all use is stored on a server at another company. I don't have access to that link, but I need...
  12. M

    Training template - controlled document?

    Hi, We are a small medical devices company and recently we have been debating if our training template should be a controlled document or not. If it should be controlled, why is that? If not, again, why? Looking forward to hear your opinions. Thank you.
  13. Q

    ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device

    The last paragraph of this clause indicates "documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization..." which appears to be setting a bar. It goes on: "but not less than the retention...
  14. 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...
  15. K

    Document Numbering (Identification) System

    I'm in the process of restructuring our document numbering system. Right now we have QCWF-1.1.1.1-01 (Name of Document). I think it's silly I want to change procedures to P001 and so on, Forms to F001 and so on, Work Instructions to WI001 and so on. We have a lot of other documents that don't...
  16. D

    Document Management System - Revisions & Out of Date Documents

    1. What happens when a document undergoes the revision process? Is the original document kept online until the revised document replaces it or does the original document get pulled until the revisions are complete (and thereby leaving users with no document to reference). 2. What happens...
  17. R

    ISO13485/ISO9001 Convenient Document Management System

    Hello everyone, I plan our future Doc Management System, we are working in electronics for industrial equipment and also plan to extend our business to Medical Device (we are a small company <20 persons). So our DMS must be ISO 9001 & ISO 13485 compliant ;) During previous experiences in Medical...
  18. D

    ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions

    Hello, I pretty much got thrown in the deep end here. I took over the quality department in our machine shop when our quality tech left for another job and our quality manager got laid off. I had no previous experience in quality and now we have an ISO 9001:2015 surveillance audit coming up. I'm...
  19. SelimStan

    How to enforce my colleagues to update SOPs?

    How to enforce my colleagues to update SOPs? as they ignore my and my Manager e-mail and the top management somehow didn't show support!
  20. R

    How to keep track of all FDA rules and regulations for medical device companies

    Is it just me or is there anyone else having difficulties keeping track FDA rules and regulations for medical device companies. The company I work at is going to apply for FDA 510k and CE mark. We follow all the guidelines, but it is getting harder and harder to keep track of all requirements...
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