In the regulated pharma environment, “what is not documented is not done”. While many organisations in the pharma industry have been using paper to document work, there has been a growing need for a leaner, more efficient, time-conserving method. This need has been answered successfully by the adoption of digitisation in pharma CQV.
Here is a first-hand account by a No deviation team member of how digital tools are helping to remove repetitive, mundane GMP documentation tasks.
Hi there! My name is Dave, and I work as a Manager of CQV Digital Transformation with No deviation. The world of work is filled with too many mundane, repetitive tasks. Digital tools aim to remove the robotic parts of most people’s daily jobs.
In my first job out of college as a freshly minted enthusiastic Mechanical Engineer on a large and exciting project, I was tasked to annotate a large number of paper test evidences to an Autoclave qualification. I remember asking myself, “Is this what I spent 4 years in university for?”, as I wrote page 1 of 98…on each page, along with the document number and signed, with the date to follow!
I am relieved to see the advances made in digitisation in the CQV world. No longer will junior engineers need to spend demoralising hours in the back office annotating attachments. They can now be simply scanned and appended to digitally executed protocols.
The pharma industry is at the start of this journey and harmonisation still has many discussions to overcome in relation to how paper and electronic evidences can be appended to test protocols in terms of the level of True Copy Verification to be applied. More conservative organisations initially required a second person to verify that that evidence was scanned/attached digitally. More recently, there has been a move away from this practice and putting the onus on the CQV engineer only.
Furthermore, in terms of standard protocol format sections, the traditional “Attachments Section” of a protocol may become a relic of the paper age, never to be seen again, as digitally executed protocols allow engineers to directly insert evidences into the test line item.
This also opens the question as to what to do with paper evidences which remain without a home on your desk after the digital protocol has been fully executed and approved.
There is much activity in the CQV digital execution space currently…
Tune back soon!
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