Healthcare technology has celebrated major advancement over the last 20 years. From needle-free injection technology to laparoscopic surgery to bionic limbs, technology has advanced medicine in new and exciting ways.
While much of the technology has changed over the past two decades, one thing has remained the same: 21 CFR Part 11. 21 Code of Federal Regulations (CFR) Part 11 is the FDA’s law for how regulated drug makers, medical device manufacturers, biotech companies, and others must treat electronic records and electronic signatures. And since 1997, FDA-regulated companies have struggled to remain compliant with 21 CFR Part 11, as they advance their technology capabilities and electronic processes to remain competitive and cutting-edge.
Now, as technology embarks on its newest frontier — Cloud-based solutions and infrastructure — FDA-regulated companies will be forced to reconsider validation, security and output from the Cloud that will stand up to the rigor of regulators. While software solutions can provide essential validation, workflow, and archiving services, this is far from a complete picture. Drug and healthcare device companies will have to again adjust their thinking to keep up with emerging technology.
Dev IQ is a trusted partner for healthcare organizations and has deep experience helping companies develop HIPAA-compliant SaaS, PaaS and Cloud-based solutions that take into account 21 CFR Part 11. To learn more about how we do it, contact us.
Marketing Strategist, busy mama & blogger extraordinaire