If a tree falls in the forest, and no one is there to see or hear it, did it really fall?
Well according to FDA rules, and othersimilar, strict interpretations of health authorities, the answer is an emphatic NO.
Even if the inspector can observe the tree on the ground, there would still be doubt about how it got there, if there is no documentation.
According to the regulators, events occur or take place only if they are well documented, as required. If you cannot produce documented evidence of certain events and actions, then the assumption is the event or action did not occur, according to FDA.
Let me say that again. If you cannot produce documented evidence of certain events and actions, then the assumption is the event or action did not occur, according to FDA.
In our world of Pharma and Life Sciences, this is an accepted fact of life and quite understandable but what if we could reduce the impact of the documentation steps on cycle times and time lines? What if there was a way of working that produced the documented evidence of actions as a by-product of the actions that were executed?
My colleagues at FDA Law Blog, in their recent article did a great job pointing out the "black & white" nature of the regulators' thinking around the importance, as well as the explicit and implicit nature of documentation of activities required by the predicate Quality System Regulations and cGMPs. I love the color they added with quotes from the movie, "A Few Good Men."
It's somewhat appropriate that the movie referenced is from 1992. All this talk about documentation as discrete steps and actionsÖto document and prove the actual underlying actions and activitiesÖthey sound so 80's and 90's. Actually, this type of discrete documentation activities date much further back, to the turn of the previous century! Seriously! Who still does "paperwork?"
Well. Most of us in Pharma still do "paperwork." I just visited a prospective customer yesterday and they described a process that included going through a check-list. First, they must find the right checklist for the task at hand. Then they print it, collecting a wet-signature at completion. Then, they send the signed form to get imaged, shredding the paper version, while sending the electronic image to a file repository. Wow! What a labor intensive process.
Haven't we advanced? Have we not been able to invent and develop technology that integrates the documentation steps right into the processes and activities?
Well, as a matter of fact. YES. The marrying of data and process, in a way that permits an organization to log these activities and document the steps and actions "in flight" is what Business Process Management does so beautifully and seamlessly.
Moreover, Appian has developed and perfected the utilization of what wecall "records." Appian Recordsconverge all process and data from across the organization on a single topic. These are the verbs and nouns of your organization; the assets you care about and manage, with actions and decisions, while taking your journey with your customers.
When you marry process and data, smarter actions are takenÖthe right data is always available without the time you currently expect for searchingÖand all those antiquated processes (you know, the paper ones!) become automated. Paper processes and data trapped deep in legacy systems represent the truth at many Life Sciences organizations. It's time that we decide we "can't handle the truth." Right? :-)
Practice Lead, Life Sciences
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