Digital and GxP compliance - a topic that is in high demand and interest these days. The general skepticism and misunderstanding of people in the quality functions of life sciences manufacturing companies is simply put; the biggest barrier currently in digital adoption. I spend so much time explaining and trying to convey the potential in digital technologies and why they are much more compliant than any paper based documentation method. The paper mindset is a shackle that all pharma and biotech companies have to cut off, now and fast otherwise the implications are dire! And, this is not news; regulators know it, executives know it, operations know it, even the quality leadership in most companies know it. That is why such concepts and guidances as Pharma 4.0, Control Strategy, CSA, Continuous Validation, etc. are being introduced and advocated.
The industries dependency on paper as a mean of documented evidence for compliance is so engrained that it more than a solution it has become weaved into the culture. The selected attempts to introduce electronic solution for compliance such as eBR, LIMS, QMS, etc have been so painful, expensive and unwieldy that they have left us grasping and finding comfort in the paper based solutions. This has left the industry is in a constant dilemma where we know we need to step into the digital era (the unknown) but feel most comfortable staying in warmth of the paper world (known). While some opt for the compromise of traditional systems as an alternative (another known).
Pharma and Biotech operations and processes are inherently dependent on data. Unlike other industries where the products are physical and you can see problems and defects, the processes can in most cases only be seen or observed through data. Yet we choose to observe by capturing this data mostly on paper and resist the adoption of digital means - why? Because of preconceived notions of compliance and painful experiences with other systems? This is mind boggling - its like someone with poor vision refusing to get a pair of glasses or contacts with obscure excuses that its "not allowed" (reference to regulatory guidance).
In other manufacturing industries operational excellence is the only way to stay profitable. In the life sciences industries the profit margins allow some leeway in productivity levels but of course have the additional burden of compliance. It means that the opportunity to gain significant productivity improvements are very high, e.g. in the CPG industry productivity increase of less than 1% are welcome. In life science not many will make an effort for such a again. With that in mind think about "the waste of documentation" in most processes - I would venture to say that there is more than 10% productivity increase potential by digitizing all paper records across most operations.
With this I am making a plea to all my peers in the life sciences manufacturing industries. Adopt a "digital anything" mindset and start the transformation. If you see a piece of paper being used that is your opportunity to start digitizing. It does not have to be an intricate complicated "system" that needs IT and top down approvals. Start small and digitize a paper a day, one paper at a time and you will become digital faster than you have ever imagined. Yes there are regulatory implication but do no use that as an excuse, start the digitization process where the skepticism (or maybe fear) is greatest, e.g. the QA or documentation departments.
If one thing you should take aways from the changing paradigm is that transforming paper to digital is not only a must but also significantly easier than it was in the past. I have said this many times, there are no excuses not to start adopting digital technology, and that means the improvements can be incredibly rewarding. Eliminate paper there are easier way to capture evidence in the digital world!
