We all have that drawer in our homes — the one filled with tangled cables, outdated gadgets, and random items that you just didn't have time to sort properly. You get an instant headache the moment you realize that the thing you're looking for must be in there.
Straightening out your paper-based document control procedures can be just as frustrating. Your systems are usually a mix of things you need, things you don't, and things you just can't part with (even if you'd like to).
As an enterprise quality management system (eQMS) provider, most of our clients are moving to our software after they've had enough of their paper systems and all of the hassles that come with them.
You don't have to live with inefficiencies, low quality standards, and daily struggles to reach compliance. Let's take a look at some of the most common document control procedure problems that we've seen and how you can avoid them.
Straightening Out 5 Common Document Control Procedure Problems
Document control procedures are the processes that documents go through to provide information and a record of the manufacturing process for your product(s). Your procedures track every step, from the initial document preparation and handling through to the final stages of the product lifecycle and beyond.
Every action taken on the documents should be tracked, including who made a change, why a change was made, and when it was made. Companies like yours use these documents to avoid mistakes, improve quality, and achieve compliance.
Here are some common problems in document control procedures that you need to look out for.
1. Problems with Collaboration During Document Creation
One of the biggest challenges with paper-based systems is the lack of collaboration. There are quite a few documents that will need input from multiple team members and departments.
Many people will attempt to solve this problem with a variety of inefficient solutions. Two of the most popular are:
Every time a document needs to be collaborated on, the person responsible for that document will assemble everyone into a room to work together. It's easy to see why this is an impractical solution.
Hybrid Digital Solutions
Other people will combine digital documents created in software like Word with paper-based tracking methods. They will keep the document digitally and email it back and forth until it's "completed" and then they will print it and put it in the folder. The challenge with this is that it becomes increasingly harder to find the most up-to-date version of a document.
Solution: Use a document management system that is compliant with FDA 21 CFR Part 11 (like Qualio). This type of tool allows for easy and simple collaboration, effectively captures feedback and redlines, and delivers a seamless feed to training processes.
2. Problems with Document Approval & Distribution
When you're using a manual system, your paper documents and precious approval folders can be misplaced or lost in someone's inbox for weeks. If someone is out of the office for regular travel or last-minute personal issues, you might experience significant delays that will ripple across your entire organization.
You might also find yourself in trouble for off-label marketing — a fairly common problem in the life sciences industry. The materials that your sales staff uses to create presentations are also traveling through your document approval channels.
When your field-based staff can't find the on-label materials they need within the timeline they need them, they will resort to grabbing whatever materials are available. So, it's no surprise that this can often lead to them using off-label messaging in their presentations.
Off-label messaging has some serious consequences for your business, products, and reputation. In fact, in recent years, major pharmaceutical companies have been ordered to pay fines of $1.5 to 2.2 billion for off-label promotions.
Solution: Cloud-based QMS platforms make document approval a breeze because you can run approvals simultaneously, which speeds the process and keeps everything visible.
3. Problems with Change Control
Change control is essential to keep a full record of your documents and product(s). However, that does not mean that your entire team should have access to prior revisions.
In a paper-based system, it's a common problem for employees to be working off an out-of-date version of a document. There is no reliable way to disable their access to past documents since it's an impossible task to track down every piece of paper in every person's inbox across the whole company.
Solution: Theoretically, change control is feasible with a paper-based system, but for bigger process changes, an electronic system can make this so much easier. There are always documents associated with any system—whether it's an equipment file containing the manual and validation or a simple SOP change—and an eQMS makes it all visible to the required parties in real time.
Related Reading: Failure to Comply - Document Control in a Regulated Industry
4. Problems with Document Retrieval
Finding a document in a manual system can be time-consuming and complicated. Employees will often give up and go off memory or their own notes if they can't find a document they are looking for.
Also, approval folders can be notoriously hard to track down. These folders typically route around the office to get signed off on by everyone that's needed. Often, your redlines and justifications will be in those folders too—making recreation nearly impossible.
Solution: Legacy systems use the old "file structure" approach, which seems fine when you're small, but that approach doesn't scale well over time. Qualio's tagging system makes it so much easier to find the documents you need when you need them.
5. Problems with Obsolescence
Earlier, we talked about the importance of document revisions and retaining access to history. However, document retention can mean that you have folders and folders of paperwork that you no longer need.
This clutter in your system can make it even harder to find the right documents when you need them.
Solution: In a paper-based system, retiring documents has to be done manually, and it's easy to miss a document. With the "periodic review" process set up by a leading eQMS like Qualio, nothing gets lost, and documents are reviewed on schedule because the task is system-driven.
The Role of an eQMS in Solving Document Control Procedure Problems
As we've seen, paper-based manual systems and partially electronic systems all suffer from time-consuming and devastating problems.
Before regulations became so stringent and competition was less fierce, old-school manual systems were sufficient.
Now, they simply can't keep up.
You need an eQMS to help you keep up with your documents throughout your entire lifecycle. From initial collaborative creation through to production and supporting on-label sales, your system will streamline and control your documents.
At Qualio, we strive to help SMBs and emerging scale-ups in the life sciences industry improve quality and bring products to market faster with our industry-leading eQMS.
Schedule a custom demo with our team and let us show you how much better your company can run when you ditch paper and modernize your systems.
"Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process." - G2 Crowd Reviewer
"Coming from a manual paper-based system, it's amazing how it all just works. It is extremely easy to compare different versions of documents during review and approval. Qualio has forever-changed how we manage document control." - Tara F., Quality Manager