Whether or not it’s Halloween, here at eLabNext, we like to tell spooky life science stories. Here’s one that got us all pretty frightened:
The year is 2023.
You’re a process scientist working in Big Pharma, and it’s your first chance to lead a commercial drug manufacturing campaign that could result in millions of dollars of profit for your company. You’ve done months, maybe years, of prep work and scale processing to prove yourself and your campaign, hoping it translates as smoothly as possible to the manufacturing floor.
The stakes are already high, with your job and reputation on the line. Then comes more stress: The FDA has decided to make a surprise visit.
Dun, dun, duuuun!
The audit process starts with a tour of the manufacturing suite: Auditors make several observations about the untidy and disorganized work environment and technicians not following SOPs or batch records.
Then, the FDA auditors bring into question the validity and origin of a particular piece of paperwork or file.
You know you have the original file somewhere. Or, rather, someone somewhere knows where the original file is. The question is, where is it, and who is that person?
Was it scanned into a computer somewhere, living in a data silo?
Was it filed away years ago and sent over to your records building?
Quality Assurance is now hounding you for proof of this one measly piece of paper, and you can’t do anything but hope and pray it turns up somewhere.
and all you find is…
Are you sweating yet? Because I am!
This horror story is obviously a worst-case scenario, but I’m sure many people reading this (myself included) have been in a similar situation. And unfortunately, this common occurrence is most likely due to the absence of proper tools that keep your data and workspace digitized, organized, and easily retrievable.
If you’re new to GMP, you may ask yourself, “Isn’t it 2023? Doesn’t big pharma and similar GMP industries have this figured out already?”
I’m sorry to report that most do not!
That’s not to say they’re incapable of following the necessary FDA guidelines for producing safe and effective products; they just tend to do it the old-fashioned way. As in, “we use excel to keep track of everything” old-fashioned way.
If this resonates with you, I have excellent news! There’s a solution to all of this:
A digital lab platform (DLP)!
Imagine all of your lab work – experimental data, sample information, lineage tracing, protocols, and inventory management tools – living on one cohesive platform. What if you never had to worry about finding that long-lost file from 15 years ago or had reports readily available for when the FDA shows up at your door? Sounds great, right!?
With digital lab platforms, you’ll have all the tools necessary to remain organized and compliant in any GMP facility.
There are a plethora of reasons to switch over to a DLP, but they ultimately boil down to 4 key points as to why your GMP facility should “go digital”:
Remember those data silos I talked about above?
The files within folders within folders within folders on someone’s laptop?
If you and your colleagues deal with this daily, you know how frustrating it is to find a specific Excel sheet containing raw or structured data through this computational rat’s nest.
Or maybe you have an inventory of thousands of samples, distributed across 20 different -80℃ freezers, and you’re struggling to find the location of a certain aliquot of a CHO cell line from last year’s campaign. Or maybe, you’re utilizing various modalities – digital and paper – to keep track of everything, and you’re struggling to juggle it all.
Sounds stressful, right?
DLPs serve as a central location for your entire workflow, offering a better way to manage your information and data.
From keeping track of projects, experiments, assays, and test results to maintaining a proper and structured inventory of samples, DLPs can be a one-stop shop to keep everything under one roof. No more data silos, no more questioning where a sample is living, and no more juggling multiple organizational tools! On top of this, many DLPs are also cloud-based, meaning you can access your work anywhere at any time.
Compliance has been a big part of my manufacturing career, as I’m sure it has with yours. And while you may think you have a decent handle on maintaining compliance, you can consistently implement tools to make GMP compliance more straightforward and certain. Audit trails and traceability of status tags, log sheets, batch records, process changes, etc., are among the most highly scrutinized aspects of an FDA audit. And unfortunately, many facilities cannot produce fully traceable change logs quickly or efficiently.
So, instead of trying to scrounge up this information yourself, let a DLP do it for you!
Many DLPs on the market offer automated audit trail capabilities, so you don’t have to worry about updating paper records.
Even better, “forgetting” to update these particular documents is a thing of the past.
Need to find who did what at a specific date and time? No problem, just search through your DLP – using simple keywords and defined search parameters – to find this exact information in seconds.
And let’s not forget about adherence to SOPs or batch records! Many compliance issues stem from technicians going rogue or working too fast and missing critical steps of a process. DLPs can be set up with digital workflows integrating SOPs and batch records. With performer and witness signatures, they can also be structured to ensure every step of an SOP is followed.
One thing that often goes hand in hand with compliance is security. But what does it mean to be secure in a GMP environment? I’m, of course, talking about the security of your data. If you’re in big pharma, your company likely has a very robust security system developed internally by your IT department. Therefore, security might not be too much of a concern for you.
But what if you don’t have these measures in place? Who’s protecting your information?
Jim, your colleague who took a coding class a few years ago, might have set up your firewall, but that won’t cut it (sorry, Jim!). When thinking about your data and protected GMP processing techniques, you should consider how this information will be kept securely. Luckily many DLP providers have done the hard work for you already!
Whether your DLP is cloud-based or not, you’ll want to be sure some or all of the following security measures are in place: a dedicated security team, third-party penetration tests, servers hosted at a site with on-site security, multiple data centres with encrypted backup servers, disaster recovery features, single sign-on, two-factor authentication, user roles and permission settings, and IP restrictions.
You’ll also want to look for the following certifications and compliances: ISO 27001 certification (this includes the system itself, not just the cloud hosting provider), 21 CFR Part 11 compliance, GDPR compliance, GxP compliance, HIPAA compliance, and FedRAMP compliance/certification. Your data is only as secure as the system it’s hosted on, so be sure to do your homework and make this a priority!
While centrality, compliance, and security are the backbones of any great DLP, one of the most beneficial impacts of instituting a DLP in your GMP environment is increasing efficiency in your day-to-day workflow. Aren’t you sick of wasting time looking for something that is unfindable? Don’t you wish you could automate basic tasks?
Think about everything you do throughout your average workday: Searching for reports, files, test results, or samples, checking inventory, stressing about compliance, organizing the manufacturing floor, and so on.
Does that take up most of your day? My guess is probably, at least, that’s how I felt!
When you lack the proper tools to do your job efficiently, much of that burden falls back on you.
Great DLPs make your life and the lives of your colleagues better! And I mean your actual life, not just your “work-life”. After all, if your “work-life” is more efficient and better organized, the rest of your actual life will be that much better.
I could go on and on about the benefits of DLPs and how they can transform the operations of your GMP-compliant facility. Still, the fact of the matter is the digitization of your organization is not up to me.
The only way to make your daily routine more organized, compliant, secure, and efficient is to take the initiative!
So, what are you waiting for?
It’s 2023. Go digital and try a 30-day trial of eLabNext’s DLP today!
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