The Importance of a Document Management System

November 20, 2023

There’s an old saying in regulated industries: if it isn’t documented, it didn’t happen.

In the past, maintaining fully compliant documentation meant handling a mountain of paper, creating extra work—and hidden risks—from a quality perspective.

Today, document management has become the bedrock of the quality management system (QMS), and is often the first solution companies roll out when implementing QMS software.

Below we explore the importance of a document management system, focusing on topics such as:

The risks of poor document control
Benefits of a document management system
What to look for in a document control solution
Key quality management system (QMS) integrations
How to use your document management system to identify process risks

Watch a free webinar on Document Management Best Practices for Life Sciences

Document Management: The Foundation of the Quality Process

A document management system is the foundation of the quality process. Trying to manage quality without a document management system is like building a house with no foundation, given its role in establishing and sustaining processes and standards.

Consider the Plan-Do-Check-Act process at the core of most major quality frameworks:

Plan: Define and document processes and objectives
Do: Execute processes according to plan
Check: Monitor results and assess performance against objectives
Act: Make adjustments and corrections as needed

Document management falls under the Plan step, where organizations set forth policies, procedures, specifications and more to guide their process. Having documentation in place is the first step in verifying that work meets standards—and making the necessary corrections to meet customer expectations.

The document management system itself is key to organizing those critical documents, ensuring they are up-to-date, easily findable and protected against unauthorized revisions.

Risks of Poor Document Control

Inadequate document control is a pervasive problem across many industries. For proof, look no further than the numerous U.S. Food and Drug Administration (FDA) warning letters citing food, medical device and pharmaceutical manufacturers over documentation issues.

Poor document control drives up risk in organizations in several ways, including through:

Added mistakes and costs
Regulatory compliance violations
Efficiency and productivity impacts

Below we look at each of these risks in more detail and what they mean for manufacturers.

Added Costs and Mistakes

Managing documentation on server drives, email and even three-ring binders is a common practice in organizations, where even small mistakes can potentially result in huge additional costs.

For example, without a centralized place for managing documentation such as product specifications, versioning errors can occur. This could mean not having the right materials on hand, leading to production delays and missed shipments. If process documentation isn’t updated, employees may assemble products based on the previous specification or procedure, resulting in defective products and complaints.

Let’s say, for example, an organization deploys a Failure Mode and Effects Analysis (FMEA) activity, where a new failure mode is identified and new detection controls implemented. If the results of the FMEA aren’t translated into an updated standard operating procedure (SOP), operators may perform testing incorrectly, allowing defective products to be shipped.

Compliance Violations

Having well-documented processes is a core pillar of compliance with regulations and industry standards, including FDA regulations and standards such as ISO 9001, ISO 14001 and ISO 45001.

For instance, “failure to establish and follow written processes” consistently appears in many FDA warning letters and 483 observations handed out to manufacturers. This underscores the prevalence of poor documentation in manufacturing today, a problem that can lead to recalls, fines and reputational impacts.

ISO, too, strongly emphasizes the role of process documentation in all of its standards. While ISO standards typically don’t prescribe how a process must be done, robust documentation can certainly benefit organizations as they work toward certification.

Efficiency Impacts

In many organizations, workers spend several hours each week just searching for information, which represents a huge efficiency and productivity drain.

It’s a common problem with manual documentation practices such as maintaining paper records or storing documents on server drives. When individuals pass documents back and forth via email, finding the most recent version can be time-consuming while increasing the risk of errors.

Benefits of a Document Management System

A document management system provides a secure central repository for organizing and managing documents across their entire lifespan. With an automated system, your team can collaborate on documents and reviews in a controlled environment, so you can:

Avoid versioning errors: The document library always provides the most recent approved version of documents, eliminating time wasted searching for up-to-date information.
Prevent unauthorized changes: Secure check-out/check-in allows users to view and/or edit documents based on their individual permissions.
Streamline document review: Organizations can customize workflows to route documents through draft, edit, review and approval stages, with automatic notifications for late or incomplete tasks. The ability to set review frequency for individual documents ensures documents meet compliance requirements and reflect current processes, reducing errors and document cycle times.
Meet compliance requirements: For regulated companies, an automated solution that ensures compliance with validation, audit trail, retention, traceability and change control process is essential. Having a single source of truth to pull up documentation helps streamline external audits, so you’re not left searching for documents when auditors request information.

What to Look for in a Document Management System

If you’re considering implementing a document management system, it’s critical to make sure the solution you choose is robust and flexible. Key features and capabilities to look for here include:

Industry-specific compliance: Regulated companies will want to make sure the system is fully compliant with relevant regulations, such as 21 CFR Part 11, FDA, and ISO requirements.
Microsoft Word^® compatibility: Most people are used to reviewing documents in Word, so you want a solution that allows you to work with Word editing features such as redlining.
Document search: You should be able to search documents using a variety of parameters. In addition to title and content, you should be able to search metadata, subject, and pertinence.
User-friendly homepage dashboards: Users should be able to view pending revisions, assignments and authorized documents from their home page, according to their permissions.

QMS Integrations

Document control touches every quality process. As such, your document management system should be integrated with other QMS solutions, the most important of which are:

Employee training: Staff should be automatically notified of new or updated documents, with any related training tasks also automatically assigned and tracked. Exams with multiple question types can also help verify that employees are fully trained on new processes.
Corrective action: Corrective actions often require updating procedures. You should be able to link document changes from the corrective action record, so your recordkeeping connects the two.
Change control: Controlled change management is central to compliance in FDA-regulated industries such as pharmaceuticals and medical device. Your document control solution should integrate with change management to ensure a closed-loop process that includes time-stamped audit trails, escalation rules and electronic signatures.

In addition to these core functions, you want a document management system capable of integrating with other QMS functions you may decide to implement. Other QMS processes closely connected with document management include:

Using the Document Management System to Assess Your Processes

In addition to helping better track and organize documents, your document management system can provide important clues around hidden risks in your processes. To uncover these risks, companies can create a frequency distribution or histogram comparing document age with the number of revisions.

As you look at the data, look for two specific scenarios: newer documents with many revisions, and older documents with few revisions.

What does this data tell you? For documents created recently that have undergone several revisions, you want to ask why the process has required such frequent change. Here the risk is that there’s some inherent instability in the process that requires attention at a higher level.

In the second scenario, you may have a number of older documents that have seldom (or never) been revised. In this situation, these processes should undergo review to see if they need updating. It may also mean that the documentation is out of date, and does not align with what operators are actually doing on the manufacturing floor.

In either case, a document management system with robust reporting will help expose these risks so you can build greater stability overall into processes and documentation.

Conclusion

Document control is the cornerstone of the quality process, setting the stage for the entire Plan-Do-Check-Act process. Without an effective document management system, manufacturers face risks ranging from recalls to compliance issues to lower productivity.

An automated document management system reduces these risks by providing a single source of truth for creating, tracking and managing documents. The result is a stronger quality process overall, especially when integrating document management with the larger QMS.

Download the AssurX Document Management brochure to learn more about how to simplify document control

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.