I had an interesting phone call today with a company named ZenDoc — www.getzendoc.com — a software company, headquartered in Dublin, Ireland.   The company contacted me to introduce me to their “new” document management software that in their words, is “new and different” from what is currently being offered for FDA-regulated companies. Although I was busy, some of the things that the gentleman said in his pitch resonated with me.   Easy to use.   Open source tools.   Web-centric.  I had to hear more. New and different — not something that this industry segment is known for.

So, during the call, I found myself one again reflecting on how much change is still needed in the software solutions offerings to FDA-regulated companies.  I see it every day:  companies using systems that no-one owns;  no-one understands;  no-one is willing to change; and no-one want to use.  As an example, I work with a client that has thousands of people as licensed users of a multi-million dollar document management system and shockingly, almost no-one really knows what documents exist inside of the system.  People can’t find documents;  they don’t know what documents apply to their particular business process or immediate need; and no-one has visibility to whether the documents work well together, in an integrated fashion.  it’s really quite troubling.  Ask about the problem and the response is invariably the same — it’s validated so we really can’t change it.   There are lots of other issues also:   poorly organized documents, lack of good metadata, no good tag library, no innovative drafting and review methods, etc.   So, after spending some time on the phone with ZenDocs today, what did I learn, what old document management demons came back to haunt me, and what are the lessons for FDA-regulated companies:

First, ZenDoc is not the future — at least not for some time.  They seem like a very ambitious, albeit very young company with good ideas and an understanding of the issues.  They are really targeting small and medium size companies, so, to be fair, they are not trying to compete head-to-head with Qumas, EMC-Documentum, SharePoint, etc.   However, they have a huge set of hurdles to overcome relative to market acceptance, technology architecture, functionality and features, and build-out of additional quality system modules that are really necessary for baseline acceptance in today’s market.

Second, I think Zendoc’s focus on a true cloud computing offering in this space is innovative; however, I think that there will be plenty of resistance with this model by potential clients for some time.   The real problem is the Agency.   From what I have seen, their Investigators are still not embracing true risk-based principles during inspections, resulting in compliance Russian-Roulette for regulated manufacturers.   Although Investigators should really be looking at the application of Part 11 and CSV in context, they unfortunately still look at these topics as risk-equivalent from a “compliance perspective” to product build controls, specification deficits, laboratory issues, etc.   In my opinion this wastes precious resources without commensurate benefit.   As your proximity from the product and the patient / consumer decreases — i.e., as you look at upstream business processes and systems, your risk is proportionately lower — not zero, but lower.

Third, I continue to believe that industry needs to do a better job framing its compliance documentation and messaging when scoping and implementing computer-based quality systems.  By that I don’t mean more validation documents.   I mean a better analysis of risk — to patient, to consumer, to product, to public health — that is incurred through implementation of systems.  However, I believe the GREATER risk is very often not having an adequate control framework for the underlying business process(es), and that risk has to be considered too.   I always say that I would MUCH rather take a hit on a 483 for a Part 11/CSV deficiency than for not having a robust control framework / system in place for the underlying business process(es) — and in today’s world — that means computer-based systems.

There is one thing though that I think I can state with certainty:   although FDA-regulated industry may not be the most innovative and creative in applying contemporary technology to regulated operations, there will continue to be change, evolution and improvement in the use of computer-based quality systems.    There is just too much broken out there for the current systems to remain static.   Investments will need to be made and new products introduced and implemented.

That is the future.

For help with computer-based quality systems and business process improvement, please contact us at 888-734-9778, or info@compliancearchitects.com.