A major goal of the life sciences community is to move away from paper-based systems, and it’s easy to see why. Some of the challenges posed by and waste associated with paper-based systems can be summarised using the acronym Tim Woods; not a real person, but full of real problems.
T – The “T” stands for “Transport”, which involves the physical movement of paper documentation around the office and around the business, starting at the printer where it is initially created. The documentation is passed around to testers, reviewers and approvers, transported from one person to the next; transported between functions and between physical locations. At the end of all of this, once all approvers have completed the approvals or the paper documentation has served its purpose, it is transported to its final destination, a folder perhaps or a document storage area. But in the life science industry we know that this paper document can be pulled at any time, for example during audits or to support investigations. And so the transportation starts again. Not alone is the transportation a huge waste, but how do you protect the document while it is being transported from file to folder and person to person? How do you assure that it will not be mislaid? How do you preserve the integrity of the document in terms of completeness, availability and retrievability?
I – The “I” stands for “Inventory”, or in this case the amount of physical documentation associated with paper processes. For example, physical retention of master copies of documentation as well as obsolete or superseded versions. The stack of physical paper doesn’t take long to become a mountain which poses challenges when it comes to long term storage and retention. Many companies within the Life Sciences sector end up outsourcing their long term storage solutions to third party which in itself introduces additional complexities around retention, retrievability and traceability.
M – The “M” represents “Motion”, which in the context of paper documentation not only relates to moving documentation around the business but also the movement of people. For example, if I need to work on the same document as you then you need the document to move to me or I need to move to the document to you or possibly someone else in the organisation.
W – The “W” stands for waiting. Only one person can work on a physical document at one time. Even if staff are co-located, there is an amount of waiting required for one person to complete their activities before the next person can perform theirs. For example, the review of a physical executed test script for a validation exercise can only be performed by one reviewer at a time. As such the next person in the chain has to wait for the previous person to complete their task.
O – The first “O” stands for Over-production and the second “O” stands for Over-processing. Paper processes, by their very nature, are often laden with inefficiencies. If you take the example of a physical documentation control process for standard operating procedures, the level of work associated with addressing a typo on a single page of a controlled SOP is often equivalent to the level of work associated with a more significant change.
D – The “D” is for “Defects”, which basically amounts to the waste associated with something going wrong. Take the example of the executed test script for a validation exercise. If the tester makes errors when recording test details in the paper documentation it necessitates a level of additional documentation, explanation and sometimes investigation and rework which ultimately generates more paper.
S – “S” is for “Skills”, when paper processes are abundant in an organisation it can often lead to the under-utilisation or poor utilisation of skills when so much labour from highly-skilled people is spent on waiting at printers, scanning documents, stamping documents, filing documents etc.
We’ve all had our own experiences with paper and its compliance and data integrity challenges, but the question remains; what does the future really look like beyond paper? One potential solution is the introduction of validated workflows. The aim of validated workflows is to eliminate GDP errors and have data integrity built in from the start, where you can’t progress to the next step until you satisfy specific workflow requirements. They have been and can be successfully used for the automation and management of validation activities, logbooks, documentation control – essentially anything that has an associated workflow.
This is exactly what we are planning to cover in our exclusive free webinar. On the 24th of October, Patrick Murray, the Compliant Cloud Technical SME for Pharma VIEW™ (Validated Integrated Enterprise Workflow) will discuss the merits of transforming regulated business from paper-based systems to validated workflows, using some common use cases as inspiration. Now is the best time to enter the world of validated workflows; the new paperless. Discover more here: https://compliantcloud.com/webinar/