EDM Submission Ref Model

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EDM Implementation Survey - Content (2 replies and 1 comment)

SEJ58
2 years ago
SEJ58 2 years ago

Hi,

To kick things off, here are some suggested questions.

Demographics

Company size

Company type (vendor, pharma, biotech, etc)

Answering for group, as an independent agent, or other

How many content management systems do you operate?

 

Target Questions

How familiar are you with the EDM?

Do you currently use the EDM?

Company wide

Selected systems (NOTE: for some companies, is there a separate system for SOPs and other non-submission bound documents?)

What difficulties have you encountered with EDM implementation?

EDM doesn't match our document structure or workflow

Lack of training or understanding

Steep learning curve or too complicated

Would take too long to implement

EDM map seems to change too frequently (unstable "standard")

No implementation guidelines

No regulatory need

Free text response

 

Please let me know what you think, especially those of you with clients. We might be able to generate questions off of their feedback.

michaeljasper
2 years ago
michaeljasper 2 years ago

Don't have any clients but I'll respond anyway.¬† ūüôā

One minor and one less minor comment -- I would be clear in survey that EDM is the EDM Model.  My first read of the above was "Do you use EDM - meaning Do you use an electronic document management system?".

 

How many content management systems do you operate?

That is actually a very big question.  I'm guessing that for any company other than a small start up, it won't be easy to answer. They have to agree on what content management is, and then look at all the systems operated by different parts of the company, each of which may not be publicizing what they're doing.

 

If you limit it to "regulatory submission content" management it will be easier - but if you intend to capture all content management (eg med info, med affairs, commercial), it gets pretty complicated fast.

 

Michael

SEJ58
2 years ago

OK, I'll work on refining the language on those points. Can you think of additional questions?

SteveScribner
2 years ago
SteveScribner 2 years ago

I feel that Michael had some good comments. Here are a few more of my own:

In the demographics section, perhaps we could also ask:

+ What location or region of the world do you live/work? (US/EU/Eastern EU/Japan/ROW)

+ What is the size of your company? # employees, Annual revenue?

+ What is your role in your organization?

+ Were you involved in setting up the EDMS for R&D or Submissions? Did you contribute to deciding on the document types and/or metadata to be included?

In the target section, perhaps it would be useful to ask about the type of EDM system that they work with (Regulatory Operations (including submissions), SOP, GMP, TMF, Sales/marketing or Other?)

+ What difficulties did your organization have in deciding which document types to include? Was the DIA EDM Reference Model a help? Which one? Then, I would include the types of troubles that you listed above. 

+ Did you find the DIA Reference Model(s) had a) too little, b) too much or c) just the right amount of detail?

+ Did you need to add document types that were not available in the DIA Reference Model? Did you delete some document types because they did not match your business model? Was that easy to do because of the simplicity of the model? What areas of the model did you add/delete?

+ Did you select your solution vendor because the DIA EDM Reference Model was already available within the solution? Did that prove to be an advantage to implementing the solution?

+ How long did it take your organization to implement the EDM? Is there anything we could do to make that easier or faster?

... Steve Scribner