As a life sciences company, how well you handle your document control can literally mean the difference between life and death.
That may sound a tad dramatic, but in some cases, your headaches can literally turn into headaches for your end users if your products don’t function as intended to provide relief.
You have a big burden on your shoulders — from your customers to your stakeholders — and you deserve a break.
Following a documentation trail doesn’t have to be so hard. Lean on our quality management industry veterans. We’ll show you some of the best document control tips that are guaranteed to make quality management at your company easier while improving your quality and saving you time.
9 Helpful Document Control Tips to Make Your Company Better
Chasing documents is never fun — especially at audit time. Use these nine tips to help you keep documents under control throughout the entire product lifecycle.
1: Give Paper a Retirement Party
We understand the chaotic comfort that your piles of paper bring. It might seem like a mess, but you know where everything is (most of the time).
Although it’s tempting to maintain the status quo, once you make the leap to a document control software, you’ll be very glad that you did.
Don’t take our word for it; see what others just like you have said after they left their paper systems behind:
“I didn't realize how much our manual system held us back. I can now accomplish 5X as much using Qualio.” — Elizabeth Fenna, Director, QA/RA, Accelovance, Inc.
“Coming from a manual, paper-based system, it’s amazing how it all just works. Qualio has forever-changed how we manage quality.” — Tara Fitzpatrick, Quality Manager, Rowa Pharma
Once you’ve migrated to a digital document control platform like Qualio, you’ll be ready to ship your documents off to Iron Mountain for storage through the life of your product and reclaim your “library” space to grow your company.
2: Focus Your Culture
Your team is a crucial part of your success in all aspects of your product. Before you can get serious about making a shift in how you control your documents, you have to consider how they will help (or hurt) your process.
Some team members will be set in their ways and will find change to be very difficult, while others will embrace the future with excitement.
It’s important that you take the time to get your team set in the right frame of mind. Help them understand why your company is choosing to focus on better document control and how their efforts are worth it. Making this shift is about more than just compliance. It’s about winning your market and making a positive impact on the lives of your customers.
RELATED READING: Quality vs. Compliance: These 5 Questions Will Determine Your Focus
3: Establish Your Workflows
Your documents need to move in a predictable and traceable way through your company from one department to the next. Every move must be documented.
Knowing how your documents should flow through your company is crucial if you want to maintain 24/7/365 audit readiness.
As you’re getting ready to map out your document workflows, ask yourself the following questions:
- How should document changes be updated?
- Who is responsible for reviewing and approving changes?
- Who will need to be notified of changes?
- Who will be responsible for each step in your new system?
4: Lean on Automation
An automated Part 11 compliant document management system can be a lifesaver (literally) when you’re in the life sciences industry. Human error can have a devastating and widespread impact on your products, your ability to achieve compliance, and how quickly you can make it to market.
5: Keep Roles in Mind
Each person in your organization has a job to do, and that applies to document control as well. You need to establish clear guidelines and rules for who is responsible for each phase of the document’s lifecycle.
The authors will be creating original documents, draughtspersons will be responsible for drafting technical drawings, and document controllers will be responsible for controlling documents and drawings through the process.
These roles and their corresponding responsibilities should be defined and clearly understood by your team.
6: Be Thorough
You should check your documents regularly for quality. Be thorough in your checks — don’t stop your check after a few errors.
As you review the documents, carefully document all discrepancies and non-conformities that need to be corrected at each stage.
7: Pick the Right Managers
It is true that every member of your team should be responsible for contributing to your document control processes, but you need to establish leadership.
Having a key contact that can make changes to the process and provide oversight will be vital to your ultimate success. This person will be on hand to troubleshoot possible issues, create templates, and keep documents flowing.
They will also be able to monitor staff and get people back on track who aren’t following the processes. Your process managers will be experts on your system and provide the pivotal point of reference that you need to maintain compliance and audit readiness.
8: Make Continuous Improvements
“Without continual growth and progress, such words as improvement, achievement, and success have no meaning.” — Benjamin Franklin
Every process has room for improvement. Set aside time on a regular basis to review your document control process and find areas for improvement. Be sure to account for the time needed to test your changes and train your team.
9: Choose the Right Quality Management System
Picking the right quality management system (QMS) can be a critical decision for the success of your company. The software that you choose will be instrumental in helping you control documents, improve quality, and meet compliance standards.
Plus, if you make the right choice, you’ll gain an advantage over competitors by being able to streamline your time to market through operating in an audit-ready state all day, every day.
But how do you choose the right QMS software for your company without frustrating your team and wasting money?
We’ll show you.
We’ve helped hundreds of organizations just like yours select the right QMS for them — whether it was Qualio or another provider. Our QMS is purpose-built for startup and scale-up life sciences companies with 5-500 employees. But we're not the right fit for every company, so we'll provide some insights into how to find the right solution.
We’ll show you the right questions to ask to help you might the right decision. Download your copy of 12 Questions to Ask Before You Buy an eQMS and set yourself on the path for success.