If there was ever a time to move away from inefficient processes, it’s now. Nicola Brady outlines paper’s many pitfalls, new risks and unforeseen obstacles that have become much more glaring in the wake of a global pandemic.
The coronavirus outbreak has forced us to adapt and change our work practices overnight without any warning. Governments have issued mandates that only ‘essential’ business should remain operational and that, where possible, ‘remote working’ should be employed to minimise the risk and the spread of the virus.
Let’s face it; this is a new reality that we are all faced with and it is hard to know when or if we will get back to the office again and back to “normality”. And when we do get back to the office, what will the new normal be?
Adapting and changing work practices so quickly and without warning is a challenging thing to do, particularly for organisations that rely heavily on paper processes as part of their business and even more so for regulated organisations that need to maintain GxP compliance.
The risks and wastes associated with paper processes have always existed, even before the pandemic forced us all to take our laptops home and attempt to continue as normal:
- Transportation of paper documentation between people, locations, etc. How do you capture chain of custody? How do you preserve integrity of the paper documentation when it passes through so many hands?
- Storage of paper documentation in a secure manner and management of previous superseded or obsolete versions can result in a significant ‘storage’ waste in an organisation.
- The process for generation, review and approval of paper documentation can be slow and inefficient. If I am an approver but you have the document, then I can do nothing until you have completed your activity.
- Paper processes can be extremely error prone and correction of errors when they are encountered ultimately generates even more paper.
- Paper processes tend to result in underutilisation of skills in organisations, where highly competent and qualified individuals may spend excessive amounts of time scanning, printing and stamping documentation.
- Reconciliation of paper documentation when it’s time to make a final decision on something can be burdensome. How do you ensure that your final paper documentation pack is logical, organised, complete and compliant?
- Master documentation is not accessible if the secure storage location is not accessible. Some organisations make provisions for this by having scanned “true copies” of the documentation available, but this is not always the case.
- Your new remote working team may never have worked remotely before. They may not have access to printing and scanning facilities, and it would be impossible for any business continuity plan to include this for every employee.
- Review and Approval processes are difficult to coordinate remotely. How do you ensure attributability for reviews and approvals? How do you manage versions and copies? Where do you store everything? How do you protect the availability, integrity and confidentiality of your documentation / records?
These are just some of the pre-existing issues with paper processes. What about the new issues that present themselves in our “new normal”, as we try to coordinate and execute these paper processes “remotely”?
To support regulated organisations trying to coordinate GxP document approvals remotely, the MHRA have issued the following guidance: ‘Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak‘ , which goes some of the way towards assisting organisations that are trying to manage GxP documents during this time.
“An organisation that coasted along happily with their inefficient paper processes before their normal was turned on its head may gain a fresh perspective as they try to manage and coordinate these paper processes remotely”
But what about the future? What if this happens again? What if the new normal is social distancing and remote working as standard? An organisation that coasted along happily with their inefficient paper processes before their normal was turned on its head may gain a fresh perspective as they try to manage and coordinate these paper processes remotely. Shouldn’t organisations that rely heavily on disconnected paper process really think about moving forward and embracing available technologies that will only bring improved efficiency and compliance in the long term?
So during this time, why not think about adapting or moving your legacy paper processes to an electronic platform? Replace your paper processes with an efficient, cost effective electronic system and enjoy the benefits of accessibility, availability, integrity and, most importantly, business continuity.