Lost, damaged or even stolen research in 21 CFR regulated industries can be a nightmare. Most of the time, you’re working with a completely paper-based process or a manual process that takes up extra time and leads to mistakes.
Document scanning and business process outsourcing (BPO) have been a game changer for industries that are held to strict regulations. With more transparency, consistency and higher security standards, they are meeting compliance standards with less risk and without shelling out more of their own time. It’s time for you to take control of your research.
So where do you start, what do you look for, and who do you partner up with to outsource these responsibilities?
Begin with the requirements you have to meet
If you are going to be held accountable for X, Y and Z then so should your outsourcing partner. Start with a list of the compliance standards, turnaround times and accuracy rates that you are expected to uphold. Look for companies with experience in your industry and high-security profiles.
When they understand the processes you are held to and can back up that experience with the security certificates to keep everything in check, it’s a win-win. Look for security certifications like SOC2 Type II and ISO 27001 that bring you an extra level of protection.
Look into what you want automated, outsourced and still run in-house
You’re not required to give up complete control of every part of your processes but you also have that option if you want it. Meeting with your team and seeing what processes you could benefit from in automating, what you want to keep handling yourself and what you feel like can be sent off to be completed by your vendor is key.
Certain benefits of document scanning and working from a digital space may be extremely appealing to your team. Additional features and workflows like automated approvals, the ability to collaborate on a single document at the same time and mobile access on tablets or phones can boost your own productivity and make for a less stressful work environment.
There are so many ways you can build these solutions out. Get creative, set goals and throw them on a timeline with your vendor. As technology grows and evolves, you can move with it but only if you take the first step to accurately scan, store and retrieve your documents.
Learn more about document scanning for 21 CFR Regulated Industries by watching the video below!