Document Management in Manufacturing

Manufacturing is a process and labor-intensive industry that requires thorough and complete documentation to keep the operations on track. Documentation can include anything from invoices, device manuals, and financial records to evidence of regulatory compliance and other executive management documents. In order to keep track of everything, manufacturers must deeply consider their document management practices to ensure everything is accounted for and easily accessible.

Before the proliferation of Industry 4.0, quality managers primarily worked with manual, paper-based documents and processes. In more recent years, document management has largely become automated and digitized, providing significant benefits to manufacturers.

However, many businesses have yet to take advantage of modern document management practices. Consequently, such manufacturing operations find it challenging to develop and maintain document integrity required for compliance to industry and global standards.

In manufacturing, document management isn’t just paperwork control. It’s how information moves through every part of production. When it fails, things slow down, errors spread, and compliance takes a hit.

A Document Management System (DMS) keeps those risks in check. It defines how procedures, batch records, and quality forms are created, reviewed, approved, and used on the floor. Each document has a job, and the DMS makes sure only the right version ends up in front of the people who need it.

Plenty of plants still rely on binders, spreadsheets, or shared drives. That might work for a while, but as operations grow and audits get tougher, it falls apart fast. Pages go missing. Old revisions resurface. No one’s sure who made the last change.

A DMS keeps that from happening. It locks down version control, tracks who approved what, and leaves a clear audit trail behind every document. In an FDA-regulated plant, that’s not just convenience, it’s compliance.

Manufacturers across a number of industries operate in a field where compliance with regulatory standards is necessary. Manufacturers of food and beverage products as well as life sciences manufacturers must be diligent about complying with relevant regulatory bodies to ensure that products are safe to use and consume.

As a result, significant documentation is necessary to provide evidence that materials and production processes adhere to the necessary standards. Batch records and device history records are just two examples of compliance records that manufacturers must keep track of in order to follow Good Manufacturing Practices as well as government regulations.

Over the years, we’ve worked with dozens of businesses that have historically used a paper-based documentation system. As we’ll discuss later in this post, there are a number of challenges and issues that can come with using pen and paper.

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Paperwork looks simple until it starts slowing you down.

A lot of factories still run on binders, shared drives, and spreadsheets built years ago. The system works, until it doesn’t. It’s enough to keep things moving, but it adds friction where precision matters most.

These are the issues that usually surface:

Missing or outdated records. When documents live on local folders or in paper binders, it’s easy to grab the wrong version. Sometimes the right one’s buried in an email chain or lost altogether.

Version confusion. Without structure, it’s hard to know who changed what and when. Revision history turns into guesswork, especially across shifts or departments.

Audit headaches. When inspection time comes, everyone scrambles to find complete records. Teams spend hours piecing together what should’ve been clear from the start.

Human error. Manual entry and retyping lead to small mistakes that snowball e.g. wrong numbers, missing signatures, unreadable handwriting.

Limited visibility. Once paperwork leaves the floor, it’s out of sight. There’s no quick way to see if procedures were followed or where a process got stuck.

According to Tulip customer benchmarking data, operators spend up to 30% of their shift managing documentation instead of performing value-added tasks. In regulated environments like medical devices, pharma, aerospace that wasted effort isn’t just a cost problem. It’s a compliance risk.

Let’s review some of the key benefits of establishing and adhering to document management best practices:

Streamlining workflows: Proper document management helps manufacturers streamline workflows by ensuring that work instructions and operating procedures are digitized and standardized across all departments and employees.

Leaning on a proper document management system allows management to instill consistency in all work across an operation. As a result, all employees are better able to perform their duties with significantly fewer errors, improving the business’ ability to comply with regulations.

Securing vital data: A loose control of documents provides various points of vulnerability for data breaches. In other words, if a manufacturer still heavily relies on paper documentation for crucial activities, there’s a chance that they could risk falling out of compliance with data security regulations.

Following document management best practices allows businesses to maintain the integrity of – and access to – their data.

Easier traceability for compliance auditing: Companies consistently need to audit their processes and ensure traceability across every stage of production to adhere to regulations in their specific industry. However, this can be challenging when manufacturers have loose control over their document management.

Simply put, manufacturers are more likely to find difficulties tracing activities and changes to documents like batch records, history records, and standard operating procedures (SOPs) if they utilize a manual, paper-based document management system.

Instant information access for flexible decision making: Modern document management systems function as more than a mere document repository. They also enable managers to respond to changing operating conditions more quickly with real-time visibility into production.

For instance, if a machine or piece of equipment develops an issue, it can back up the production line, affecting productivity. Additionally, it can produce defective products that don’t meet the necessary quality or regulatory standards.

With a more defined document management system, relevant personnel can quickly call up instrument manuals, SOPs, and guides to deal with the faulty machine. In so doing, downtime is reduced, and the line becomes productive again in a significantly shorter time.

Regulators expect every step to be documented, stored securely, and traceable. FDA 21 CFR Part 11, ISO 9001, and GMP all point to the same requirement: the ability to show what happened, when, by whom, and under what conditions. If there’s a missing link, the entire record is in question.

A digital document management system brings that traceability into daily operations:

Controlled versions. Only current, approved documents are available on the floor. Older ones are automatically archived so no one’s working from an outdated SOP.

Full logging. Edits, approvals, and access are all captured with timestamps and user credentials, creating a built-in audit trail that doesn’t rely on manual tracking.

Electronic signatures. Systems configured for FDA 21 CFR Part 11 compliance meet the same expectations for authenticity and accountability as traditional signatures.

Simpler audits. Teams can retrieve complete document histories in seconds instead of digging through binders or drives. What used to take days now fits into routine prep.

Connected records. Document activity can link directly to production data, operator entries, and equipment states, giving quality teams a clear picture of what actually happened on the line.

With a digital system in place, compliance stops being a last-minute scramble, and becomes a built-in part of how work gets done.

Tools that can help digitize document management practices give manufacturers a massive leg up when it comes to keeping various documents and compliance records in order. The adoption of such technology particularly helps make compliance efforts more seamless and manageable.

Here are some of the ways that digital solutions help streamline document management in manufacturing:

Central document repository: Traditional, physical document management makes it easy for paperwork to get damaged, lost, or misplaced. After all, the documents are spread across different departments and production sites, making it more challenging to find the information you need.

But when it comes to software, all documents are housed within a centralized database, allowing different departments to store their records as well as other relevant quality and compliance information.

Easier collaboration: Manufacturing operations consist of several interconnected processes that require collaboration between various departments. In a more traditional document management system, significant time would be wasted shuttling back and forth between departments.

However, most digital solutions contain collaboration features that enable widely spread employees in different sections to work on a given process via document management solutions. Consequently, communication integrity is maintained, allowing for seamless collaboration that improves productivity. For example, Tulip’s Workspaces functionality helps make communicating between multiple locations and teams simpler than ever.

Better access control: Because it’s easier to collaborate with different remote parties, some concerns might arise regarding access to sensitive documents. However, most digital document management systems will allow management to determine who has access to a given document.

Additionally, the software maintains a trail of different personnel who are granted access and the times that they viewed or edited specific documents.

Quality process automation: corrective and preventive action (CAPA) can benefit significantly from the automation features provided by document management software.

The software enables quality and compliance managers to keep track of relevant documents in one place regardless of the department of origin.

Accurate document tracking: In manufacturing, it’s common for businesses to update their processes in an effort to continuously improve their operations. However, this also means updating various document types to ensure processes are consistently validated.

Document management software automatically keeps track of all changes, providing managers with all versions and revisions of a particular document. This is crucial in audit trails, with the added benefit of identifying the individuals with a hand in those document revisions and approvals.

Paper systems are familiar, but they drag you down. Time gets lost in tracking versions, audits take longer than they should, and it’s hard to see what’s really happening on the floor.

A digital document system fixes that by putting control around how information moves. Every record is current, traceable, and easy to find when you need it. Teams stop chasing signatures and start focusing on production.

The change doesn’t have to be massive. Start with one process, prove it out, and expand from there. The result is steadier operations, fewer errors, and less stress when regulators show up.