Working with Orcanos DMS (Document Control) and Dropbox

Rami.Azulay June 2nd, 2015 Posted by Rami Azulay( ) 21 CFR Part 11, Document control, FDA, ISO 13485

OVERVIEW

This article is targeted for medical device manufacturers SMB’s working with Dropbox as their main collaborative environment for document sharing. It describes the process of working with Orcanos Medical and Dropbox.

ORCANOS DMS BENEFITS

  • Import your existing QMS files and folders in one click
  • Part 11 compliant, automatic revisions control.
  • Obsolete documents – Assures that users don’t use obsolete revisions – Orcanos adds watermark “Obsolete” when a new revision of a document is added along with an effective date
  • Sign documents electronically, directly from your email, next singers are routed automatically
  • Ability to export entire DHF to file system with one click
  • Publish documents to PDF upon approval, and attach a cover letter
  • Organize documents hierarchically, and allow to share a document on different locations
  • Available anywhere, anytime

WORKING WITH DROPBOX

Advantages

  1. Easy to manage and configure
  2. Easy to share
  3. Available anywhere anytime

Disadvantages

  1. No revisions control (A, B, C…)
  2. No option to electronically sign documents, including routing process definitions, etc.
  3. Not part 11 complaint
  4. Each document has multiple instances per revision, for example, FMEA_A_1.docx, FMEA_A_2.docx, FMEA_b_1.docx. The Quality control manager needs to save an instance of the document after every change he wishes to publish, manually
  5. Hard to share all last approved documents, for example. This has some risks, as a user can work on an obsolete version of the document, without knowing there is a new version
  6. Signing a document is done in the old “Classic” way of printing the document and sign with a pen.
  7. Managing the routing process manually, while the organization is spread over the globe makes it harder to finish an approval process on time.
  8. A cover letter is manually built.

WORKING WITH ORCANOS DMS AND DROPBOX

Signatures and revision management and control are done in QPack DMS

  1. Establish a new tree structure with last revision of the document (or last edition of not approved)
  2. Clean document name format, so instead of FMEA_A_2_approved.docx, make it FMEA.docx
  3. Import entire tree to Orcanos DMS
  4. All documents will get revision A.1 automatically
  5. Sign documents on Orcanos
  6. Now export DMS content using Orcanos DMS Export for released revisions. Note that approved files of type WORD will be downloaded as PDF
  7. Share this tree in Dropbox
  8. Configure the Dropbox sharing options
  9. QA will refer to Orcanos DMS only
  10. Users keep working on Dropbox
  11. Whenever file needs to go through a signing process – it is uploaded to Orcanos and get controlled by Orcanos


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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