Pharmaceutical Product Website Management: Helping IT and Compliance Do Their Jobs
Overview: An outline of recommendations for managing development, editing, approval and publishing of pharmaceutical product marketing websites.
For: Website developers, in-house IT teams, in-house marketing teams, in-house compliance teams.
Like all product websites, pharmaceutical product websites have to meet the sales, marketing and IT needs of their parent companies. But they also come with a bunch of other requirements that are unique to regulated industries (particularly if the products are non-OTC).
Legal, compliance and regulatory teams and agencies may need to review, approve, “roll back” or completely eliminate specific content, pages or entire websites – and it often needs to be done immediately. This can be a surprisingly difficult (and potentially costly) process if you aren’t prepared.
So, after putting out a few fires and assisting frantic IT teams, here are our recommendations for managing pharmaceutical product websites.
1. Full backup upon every major site edit, and backup archive.
First, regulators may ask to review your full site as it existed on a specific date. Second, your legal department may require the same thing. Finally, you may be required to “roll back” the website content and functionality to a previous version on a site-wide level. So make sure you have a full backup that you can present online if necessary.
2. Four functional copies of the website for different purposes and stages in the development, approval and publishing process.
First, the live/production site that is visible to the public.
Second, a password-protected “validation” site that will be used by compliance, regulatory and legal teams to review and approve the site before it is published and replaces the existing live site. Once this is approved, this site is moved to production.
Third, a password-protected “test” site for marketing and IT teams to review content edits made by the marketing team and technical edits made by the development team. Once these teams approve this website, it is moved to validation.
Fourth and finally, a development site dedicated to your development team to work on and test technical edits.
3. Rapid shut down process and assets.
This is the worst-case scenario: your compliance team or a regulatory agency requires massive or site-wide content edits and the existing site simply cannot be visible to the public until a new website and content is approved. Some people call this a “kill switch” or a “shut down site.” No matter, you need to be prepared for the worst. Please see our blog post dedicated to the process of taking a website down (the “kill switch” process).
4. A content management system (CMS) so you can quickly edit content and “roll back” content on specific pages.
A good CMS makes it easy to edit content and, if required, “roll it back” to a previous state if issues arise. A CMS will also keep track of when edits were made and who made those edits. Finally, it can make it easier to manage “moving” the site through the various sites in the approval process.
5. SVN system for the development team.
This is a little geeky, but it helps the development team track technical changes and when those changes were made across all your websites. An SVN is an invaluable tool to keep things coordinated and manageable.
Some folks may think that this set up is excessive or too time-consuming, but non-compliance or regulatory errors can be extremely painful for a company. Also, Eric Weidner recently spoke with a corporate insurance attorney who mentioned that insurers are starting to look more seriously at how pharmaceutical companies maintain website assets and the processes they have in place for potential emergencies. This is definitely a case where “an ounce of prevention is worth a pound of cure.”
If you have additional ideas, think your business has a great way of handling website management, or think we missed something, please let us know. We’d love to hear from you!
Yours, Gleb Aksyutchenko and Eric Weidner
This entry was posted on Thursday, December 1st, 2011 at 6:56 pm and is filed under Biotech & Pharma, Technology. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.
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