As a life sciences company, your responsibilities are vast. You have investors, inventors, regulatory agencies, and consumers that are counting on you to be at your best. Your products will change lives and advance healthcare for people everywhere.

You are at the forefront of innovation — yet you may still be relying on paper-based systems to track your work, even though you know the risk of human error is high.

When your systems are outdated, errors are unavoidable. It’s not a matter of if there will be an error; it’s simply a matter of when. Failure can result in you losing certifications and disappointing your customers ... or worse. Low-quality products give your competitors the chance to surge ahead and will cost you market share.

We've seen a lot of document control system problems. That's one of the reasons we exist. We built our software to help save you from bad and inefficient practices that could delay your product coming to market.

Let's look at some of the common mistakes and how you can build in checks to keep them from happening.

6 Common Document Control System Screw-Ups That Hurt Life Sciences Companies

Efficient document control is an ongoing struggle for life sciences companies. If you fail to keep track of everything, your risks are substantial.

If you’re modifying, correcting, or setting up your document control systems, keep these common blunders in mind to avoid making them yourself.

Blunder 1: Letting Versioning Get Out of Control

It's important to maintain clean records of your specifications, purchase orders, and other important documents. However, it’s easy to get carried away and store too many versions of your files.

Having too many copies can lead to costly errors such as incorrect orders being placed, delayed production schedules, unplanned downtime, reduced operational efficiency, and even a delay in your time to market.

If you are using paper-based document management, it’s going to be significantly harder to keep your paperwork in order and keep track of everything. Switching to a more efficient automated system with versioning controls is one of the easiest ways for you to tame your rogue documents.

However, just upgrading your systems isn’t the only way to avoid problems. You also need to set procedures for “self-destructing” obsolete documents and have a way to ensure that everyone is always working on the most up-to-date versions.

Also see: What Is a Document Control System and Why Does it Matter?

Blunder 2: Not Organizing Your Document Lifecycle Management

In a paper-based document management system, document routing is one of the most time-consuming and physically demanding chores your team will tackle. Shuffling paperwork from one department to the next for approval, archiving, and distribution is tedious and prone to errors.

Your management team also loses the ability to keep track of the progress of the documents — resulting in disorganization so severe that it can threaten your compliance. Vital documents are often scattered across a multitude of departments and stored in a wide variety of different file formats.

Switching to an enterprise Quality Management System (eQMS) can alleviate many of the issues that you face in a paper-based system. eQMS software allows any authorized user to view documents regardless of department. Users are able to easily see the full document record, examine past versions, view approvals and approval process, and determine the present state.

Blunder 3: Not Having an Efficient Process for Administration

One issue that we see in legacy systems is the lack of process and document management. Administrators and other users are often confused about which steps the documents need to go through in their lifecycle.

Paper-based systems typically rely on paper-based processes. These can be hard to understand and complex for new employees to comprehend. Often, only the people that created them originally fully understand the document management process from beginning to end.

When information is trapped in the brain of one user, you run into potential issues with compliance and employee training.

Instead, digital systems give you the ability to implement document workflows. These workflows are intuitive and easy to follow so users are never left guessing what the next step should be. New managers can easily go through training inside the platform to get up to speed very quickly.

Blunder 4: Spreading Your Information Across Multiple Systems

Over time, many users recognize the inefficiencies of paper-based systems. So, they begin looking for more efficient alternatives. This often results in discrete pieces of the document control system being migrated into disparate systems.

For example, you may choose to implement a revision control system. You may be manually scanning your documents in different versions and allowing it to keep up with your revision history.

Later, you may decide that having a digital document archive is beneficial. When documents reach the end of their lifecycle, you assign someone to scan them.

What you ultimately end up with is a system of disconnected data. Employees and management have trouble finding the documents because they don’t know where to look. It can also be very challenging to gather the full history of a particular document when it has moved through multiple systems.

RELATED READING: 4 Part 11 Compliant Document Management Systems You Should Know About

Blunder 5: Not Planning for Change

Most companies are in the process of continual growth. From one year to the next, their products, systems, employees, marketing, and many other aspects of their business will change.

Most companies plan for this change for specific parts of their business. They will discuss future goals with marketing teams, plan ahead for hiring, and set projected revenue goals, but they’ll forget to plan for their document control needs.

As you grow, your document control needs are going to change with you. You will go from managing just a few documents for a few products to managing thousands of documents and revisions across all of your product lines. Your document control system planning needs to not only account for your immediate needs, but also needs to consider future needs with room for unexpected changes.

Blunder 6: Picking the Wrong eQMS

As you’ve probably realized, your document control system is incredibly important. How you manage your documents defines the quality of your final products. It determines whether or not you will be able to achieve compliance in your sector.

Moving from paper-based systems to digital is a big step. Choosing the right software is at the top of your list. Different quality management systems provide different sets of features. It’s important for you to review and consider what those features are and how they can help your company succeed.

Start by compiling a list of your immediate needs as well as your current struggles. What steps in your process are leaving you vulnerable now? How can a software system help alleviate that pain?

If you manage quality for a life sciences company with 5 to 500 employees, Qualio may be a good fit for you. The best way to determine if our eQMS is your best option is to schedule a demo.

Our demos are more than just a 20-minute software pitch. They are custom-tailored to your needs and designed to address your questions. Ultimately we want to make sure that you are going to be satisfied with our platform.

Book your demo now and see everything that Qualio has to offer.

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Published by Robert Fenton September 3, 2019
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