I often speak to quality leaders and other executives who boast that their paper-based quality management system is “perfectly sufficient” to meet the needs of their business. I just nod and smile because I anticipate that I will be hearing from them (in a panicked state) in the very near future when they realize the limitations of a manual QMS.
Many businesses are still operating under the auspice that investing in technology- specifically software- is a cumbersome and expensive endeavor that only large, budget-rich companies can realistically pursue. However, thanks in part to the consumerization of IT and the advent of cloud computing software, that is no longer the case. And companies of all sizes now have access to affordable, easy to implement software solutions including eQMS.
But when is the right time to purchase and implement an eQMS? Here at ZenQMS, we advise quality leaders to look for the following indicators as signs of readiness to move from a manual to an electronic quality management system:Your business is being audited frequently
If your business is regularly being audited by your customers and/or the FDA, then you likely appreciate what a significant drain on resources each inquiry represents. It’s a burden, and the best facility in the world will be judged (sometimes harshly) by an auditor who sees people running for paper files that may have mistakes in them or waits too long for answers. We can roll our eyes but the truth is that professional auditors don’t have this experience everywhere they go. Put your best foot forward.Your training matrix is becoming too big to manage in spreadsheets
The training matrix is both a blessing and a curse for life science companies. It makes it easier to assign training based on job function or role and ensures that trainees are compliant but quickly becomes an administrative nightmare to maintain and scale. We see a breaking point for companies when they get > 20 employees and > 50 SOPs. It’s not that’s not possible...it just gets harder to manage and easier to make mistakes.
You lose or can’t easily find documents
We know it’s true. And it’s ghastly when it happens— losing a document in a sea of binders or behind a desk is a real thing. Even worse, losing track of the actual, final executed copy of a document in a sea of digital folders on your S-drive. And we can all agree it’s not a good look when an auditor or inspector is waiting.
Your workforce includes multiple locations and/or remote workers
The reality of the modern workforce is that you are likely to need to collaborate with workers located in different regions all over the world, in multiple office locations and with those who work from home. This is definitely true of start ups. Electronic document signature solutions are a no-brainer today but it is critical that regulated companies only use those solutions that are fully validated.
Your audits result in Major/Critical findings and/or warning letters/483 from the FDA
This one is pretty black and white— if you are getting called out for not demonstrating span of control around your documents, training program, CAPAs, Change Control or Audits/Supplier quality programs please know that an electronic system can help. I would add this personal note: I have seen too many times that implementing many manual workarounds and layering on more SOPs and structure into a manual system just creates more opportunities to fail. Asking for time to implement a new system is something that auditors will definitely make allowances for— before you hit the start line on 1000 other things, consider shoring up your base with a good electronic system to manage these critical to quality activities.
If you are experiencing any or all of the above, schedule a demo of ZenQMS today: