Hi folks.
Let me just add in one other key consideration in my mind. While you are talking about a "small company" today with possibly very few, if any, documents needing eCTD....please also consider the future of what the company will look like 1, 5 or 10 years from now. Keep in mind, whatever your decision today, to obtain the best ROI for the solution it must be scalable, longitudinally manageable, and cost effective. Scalable I don't think needs a definition. Nor do I believe cost effective needs a separate definition in this case. What I mean by longitudinally manageable is that over time your needs, requirements, expectations, and processes are likely to change and often they will become more specific to your particular company, company culture and product types. In order for a good eCTD decision to be made regarding proper publishing process and therefore proper publishing choices, you need to consider that aspect as well. If you choose to go with the "simple" fix of outsourcing your process that will work for many types of companies but you must remember that you are still ultimately responsible for the information provided through your vendor and there are vendor acceptance requirements that will need to be met and audited. If you choose a more "complex" fix of bringing all of the information build in-house then you still have vendor requirements but you also have the need for additional support internally (or possibly outsourced - remember vendor requirements here as well) and the need to update/upgrade over time with patches, fixes, new options, etc.
So my point here is really be sure what you want to do with the programs and projects before you go deciding on how you will get there. Far too often in my personal experience have I been in a meeting 3 months into "implementation" or "validation" or "verification" programs only to find out that the company has not really understood what they plan to do, who is expected to do it, what resources are available, what the expertise of the individual contributors might be, and what the "true" costs of the system actually are. When you get to this point, you have a lot of capital sunk into the project already and most companies won't want to "abandon" the project at this point and start over which makes the project that much more difficult to manage and deal with. So know what you want, who you have, what capabilities are available on staff (or in potential increased headcount for the group) and seriously consider what you will need longer-term in order to get the best cost effectiveness out of your choice. Without knowing this when you embark on review and decision-making for this type of thing, you are unfortunately doomed to failure at some point - it might work just fine for a while even but it is going to come back to haunt the company in the long term if you don't understand these issues up front and make it a point of providing this information to any of the developers that you consider moving forward with to pricing, presentations and ultimately purchases.
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States
Original Message:
Sent: 16-May-2016 01:15
From: Daria Wain
Subject: In house eCTD publishing opinions needed
Hi Sarah,
It's possible to publish eCTDs, provided you have the right software solution for your company. If you don't have eCTD publishing software, there's many considerations you'll have to make regarding which software to purchase.
As a starting point, there are three obvious ways to access eCTD publishing software: a local installation of the software; a "cloud"/"software-as-a-service" hosted instance of the software; or outsourcing the publishing to a 3rd party vendor. Each of these solutions will be able to publish your eCTDs, however with different limitations, functionalities and, importantly for small companies, different price points.
You'll find it worthwhile to do some research to determine what will best suit your company's needs. I hope this information is a good base to start from.
Kind regards, Daria
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Daria Wain
Pharma To Market Pty Ltd
Queensland
Australia