3 reasons generic collaboration software doesn’t work for regulatory teams

But you’re not a general business. You’re a life sciences company. If you’re using generic collaboration tools for content collaboration, your process is likely not optimized or as stringent as it could be–and your regulatory and legal teams are drowning because of it.

Content collaboration is different for life sciences companies

Think of all the different types of content a life sciences company develops and utilizes: promotional content, medical/scientific content, corporate communications, internal communications, training materials, references, key claims, labeling design, technical documentation, contracts, grants, and investigator-initiated trials. 

For each, you have to bring together key experts from marketing, medical, regulatory, and legal to vet the content and ensure it is on brand and compliant. Your content review software needs to follow specific regulatory standards, like being in compliance with FDA 21 CFR Part 11 and EU Annex 11 for electronic records and eSignature. In the case of an audit, you need to be able to have an easily-accessible audit trail that tracks actions performed on a piece of content.

Your content collaboration software also has to be easy to use. Regulatory and legal teams are tasked with balancing thoroughness with speed–tools that slow down the process or create unnecessary frustration simply won’t work. 

Let’s review the specific pitfalls of generic collaboration tools for regulatory teams at life science companies and provide some insight on what to look for in a collaboration tool or software. 

Reason #1: It’s difficult to collaborate

Generic collaboration software like SharePoint and Documentum were not specifically created to help marketing, medical, legal, and regulatory experts at life science companies collaborate. 

As an regulatory reviewer, have you ever felt the pain of:

• not being able to link specific claims to references?
• felt lost in a review cycle, not sure where a piece of content is in the review process?
• not being able to meet your PRC or MLR goals such as first pass acceptance or a specific time to approval?

You need software that emphasizes speed to market and collaboration simultaneously. With a system that’s easy to use and navigate–like Pepper Flow–you can spend less time figuring out what’s on your to-do list and more time providing comprehensive reviews. Minimize frustrating back and forth during reviews by being able to discuss, vote, and provide clarity around feedback in real time. 

Reason #2: Compliance features are lacking

Generic content collaboration tools tend to lack features that support the GxP compliance needs of a life science team. Without specific compliance features, you’re not only putting your organization at risk but you’re also taking on the giant burden to fully validate generic tools for adherence to regulatory requirements and intended use.

With generic tools, you are likely finding yourself wishing you could do more with your technology. For example:

• does your team struggle to know and follow your defined SOP for content reviews? Does your content collaboration tool enforce your company’s process through configured workflows?
• does your generic system capture all of the required electronic records and electronic signatures in compliance with 21 CFR Part 11?
• does your team spend lengthy time on validation activities for your content collaboration tool or skip the software validation process entirely?

You need software from a team that understands that compliance doesn’t need to be complicated and is laser-focused on ensuring all regulated functionality consistently operates as intended, backed by a rigorous validation process that reduces the validation burden on your team. Alleviate concern and worry about maintaining your process compliance with life-science specific features like:

• eSignature in compliance with FDA 21 CFR Part 11 and EU Annex 11
• audit history
• version control
• document expirations
• claims and reference linking 

Reason #3: Training time too long or inconvenient

When a new person joins your team as a content reviewer, how long does training take? Does it take days to get them onboarded? If you’re working with different content collaborators like agencies and regulatory reviewers, you need to be able to onboard your team quickly to your system and process. The longer or more confusing the training process, the longer it will take you to move through your content review process.

You need software that’s as easy to learn as it is to use. Look for software options that don’t require lengthy training–ideally you can get up and running with just one training session. Ongoing support from your technology partner like resources, training, and user webinars are also something to look out for. Most importantly–the more intuitive the interface, the easier it will be to use the software and move through your content review process with speed and efficiency. 

Simply put, generic content collaboration tools aren’t purpose-built for the unique needs of life science companies and regulatory teams. They are a one-size-fits-all for all industries, and your teams are suffering because of it. But note: features aren’t the end all be all. Make sure to select tooling that comes with a software partner that is committed to your success and is there to support you every step of the way.