Congratulations! So, you’ve decided to adopt a compliance software tool for your life science organization. However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?
1. Determine the Scope of Implementation
How wide is incorporation going to stretch in your organization? This is a vital question to answer as you look toward adopting any new compliance software tool. While each life science business handles scope in its own way, there are -a few common approaches. You can decide to incorporate tools by:
- Department
- Project
- Team
- Development activity
- Product lifecycle stage
Whichever approach you choose to apply, a new software tool also depends on your business’s maturity in the marketplace, portfolios, size, project timelines, and so on. All of these factors influence your organization’s capabilities to adopt and use new tools, and should be evaluated early on in the process.
2. Get Buy-In
Getting buy-in on compliance software needs to happen at both management and development team levels. Higher-ups want to see how the tool improves efficiencies, reduces costs, and so on. Development team members—who will be using the tool daily—need to understand its value for their work and how it impacts their activities.
Essentially, you can consider management and development teams as stakeholders whose needs you are trying to meet. Approaching both groups with this frame in mind can get them on board with adopting the compliance tool.
During the process of obtaining buy-in, it’s worthwhile to keep the discussion open, listen to concerns, and address questions people may have. As implementation kicks into gear, you can incorporate any feedback you get into that process. This can better align the tool to people’s expectations, unify goals for using the tool, and identify areas for future improvement.
3. Assess for Risk
Risk assessment is one of the most critical activities your organization can undertake when adopting compliance software, as it helps you understand the tool’s impact on your development activities. Assessing for risk is also necessary for compliance. Because the software inevitably enters your quality management system, ISO 13485 and regulatory authorities like FDA require the software to undergo risk evaluation.
4. Plan for Validation
Along with risk assessment, validation is another compliance activity that must be done when incorporating new software into your quality management system. Prior to full operation, your team should plan to run validation exercises to ensure integrity and performance. After that, establishing timelines, technical needs, and responsible parties for future validation allows you to manage this aspect of regulatory compliance.
5. Coordinate with the Vendor
Engaging in collaborative efforts with vendors of compliance software tools can get your organization headed toward smoother, more robust operations. Vendors know their tools best, and likely have experience from working with other life science organizations that you can leverage. Coordinating with vendors on things like validation, implementation timelines, scope, etc. can identify possible areas of concern as well as potential opportunities. Their perspective and experience can only benefit your organization’s efforts.
6. Evaluate at Regular Intervals
While all these best practices and tips are aimed at making compliance software tool use easier to manage, the process is almost never smooth. Hitting bumps in the road should be expected; looking back at them allows your team to learn and adjust more easily. Conducting regular evaluations generates insight into:
- The dynamics of software tool usage
- Compliance activity improvements and challenges
- Adoption rates
- Issues that need to be managed
From these, you can build on the things that are going well in adoption and come up with solutions for things that need improvement. Sharing these perceptions with the vendor is worthwhile, too; they may have thoughts or ideas that you may not have been able to see. They can then assist you in adjusting your version of the software to accommodate challenges and solutions that improve compliance activities in your organization.
