Opening Pathways to Interoperability
T-minus 21 months until DSCSA Nov 27, 2023......
While much has been and continues to be done to move the industry towards a path for secure and electronic interoperability, to quote an 80's movie theme song:
"We've got a long way to go and short time to get there!"
It's not an unreasonable reaction to feel the panic kick in as many big questions remain but there are already things that all this work is making clear, interoperability does not work without alignment and eventual adoption.
This is very easily said but much work is involved in answering:
- What is the industry aligning on to enable a secure, electronic and interoperable manner?
- How fast minimally is "promptly" facilitating the gathering of information in the event of potentially harmful product?
- How does adoption happen across an incredibly diverse ecosystem of systems?
The Explore and Pilot Approach:
Looking back at an article we did a couple years ago to help the pharmaceutical industry better see the need for collaboration for patient safety and compliance with DSCSA. While the most important work continues to be done in cross industry work groups, we should not lose sight on the need for each segment to align their peers as well. We are proud to have helped a small group of leading manufacturers highlight some important issues but more hopeful that the process we outlined can be leveraged in work both within each segment and in cross industry groups.
We encourage our clients, peers, partners and yes, even competitors, to see the need to move the industry from a zero sum game approach that delays a path to interoperability and creates room for bad actors into a realization that the industry is better and patients are safer as the data moves securely with product.
Please let us know if you have any questions and as always, we welcome your feedback and comments!