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by QT9 Software on January 15, 2026
In 2024, the Manufacturing Leadership Council reported that 70 percent of manufacturers surveyed still entered data manually. Though the council's 2025 report indicates that tide is changing, the truth is that many organizations still manage quality with spreadsheets and shared drives, creating hidden compliance risks and hindering audit readiness and operational efficiency.
Manual methods can work at the outset of your quality endeavors, but they can also stymie growth and feed inaccuracies that hurt your business in the long run. In a recent episode of the QT9 Q-Cast, Angela O’Sullivan, Director of Operations for QT9 EU, unpacks the hidden costs of paper-based, manual, fragmented quality systems and describes how modern, integrated QMS platforms shift quality endeavors into a driver of business growth.
Contents
Why paper-based quality systems persist and why they're risky
Impact on audit readiness and compliance
Three levels of QMS maturity and why you should skip Level 2
Understanding the true cost of quality
A mindset shift for quality leaders
Turn quality into a strategic advantage with an integrated eQMS
Why paper-based quality systems persist and why they're risky
What keeps manufacturers stuck with inefficient quality systems? Despite increasing regulatory complexity, many organizations still rely on paper-based or partially manual systems for a variety of reasons.
O’Sullivan says it is often driven by fear of change, lack of buy-in, budget concerns and misunderstanding about return on investment. For new businesses, especially, paper-based quality management may appear “good enough.”
But the hidden costs can be significant. “Any manual process has a risk of human error,” said O’Sullivan. “Using the incorrect version of a document - you’re making the wrong parts. Using equipment that’s out of calibration - you’re talking about defective products.”
Beyond inaccuracy, paper logs introduce data integrity risks that are easy to overlook: ink fades, documents degrade and physical records are vulnerable to loss from fire, flood or simple misfiling. These mistakes can cascade into recalls, audit findings or, worse, patient and customer safety issues.
In contrast, electronic QMS platforms provide controlled access, document version control and secure data retention, reducing both operational risk and long-term cost.
Impact on audit readiness and compliance
A major impact of disconnected manual quality processes is on audit readiness. “You have very limited visibility as to where you stand with regard to the audit,” said O’Sullivan. “It’s a little bit like not being able to see the wood for the trees.”
With manual systems, quality teams don’t get real-time visibility into important data, such as open CAPAs, audit findings, training records and document linkages. Preparing for an audit becomes an exercise in cross-referencing spreadsheets, binders and folders, making it difficult to retrieve documents during an audit.
Retrieving the right document revision or demonstrating traceability across CAPAs, training and document updates becomes significantly harder when systems aren’t connected. An integrated QMS changes this dynamic by making relationships between records visible and retrievable in seconds.
“With an eQMS you can put your hands on the data really quickly and give that confidence to the auditor that everything is where it should be,” said O’Sullivan.
Three levels of QMS maturity and why you should skip Level 2
More and more, regulatory bodies stress the importance of developing a mature quality system. O’Sullivan categorized quality system maturity three ways:
Level 1: Hybrid Manual Systems
Hybrid systems utilize a combination of paper, electronic spreadsheets, word processing documents and other disconnected files, which form the backbone of the QMS. This is the most basic, risk prone and least scalable model.
Level 2: Islands of Software
At this level, organizations add stand-alone software tools for various functions, such as complaints, calibration, document control and risk management. Each system operates independently, creating silos and user fatigue.
Level 3: Fully Integrated QMS
At this level, all quality processes live in a single, integrated, connected platform with shared data, workflows and reporting.
O’Sullivan’s advice: If you’re at Level One, skip Level Two and go directly to Level Three. “Level Three is the most efficient way to manage your QMS,” she said. “Ideally go from Level One to Level Three and do not go through that Level Two hybrid period.”
Moving directly to an integrated QMS reduces long-term cost, simplifies user adoption and improves compliance visibility across CAPA, document management, training and audits. Moving through disconnected software systems often increases cost, complexity and resistance to change. A direct move to an integrated eQMS delivers faster value and avoids long-term inefficiencies.
Getting to Level Three often involves taking a hard look at your current Cost of Quality (COQ) as well as potential return on investment (ROI).
Watch the QT9 Q-Cast podcast and learn how a fully integrated electronic QMS gives you a competitive advantage.
Understanding the true cost of quality
Every organization pays for quality, whether intentionally or through failure. O’Sullivan broke this down into two categories:
Cost of Good Quality: Prevention and appraisal activities such as training, calibration, audits, inspections and process controls.
Cost of Poor Quality: Internal failures (scrap, rework, downtime) and external failures (customer complaints, recalls, warranty claims, lost business).
While internal failures are expensive, external failures are often the most damaging. Beyond direct costs like travel, screening and replacements, reputational damage and customer trust erosion are difficult to quantify. These losses often far exceed the original cost of prevention.
An electronic QMS supports better tracking, root cause analysis and corrective actions, helping organizations shift spending toward prevention rather than cleanup. This visibility also makes it easier to demonstrate ROI when justifying QMS investment to leadership.
A mindset shift for quality leaders
O’Sullivan emphasized the necessity of quality leaders to embrace a change in mindset. “There is this thing called founders bias, where people get attached to something that they’ve created … and they don’t want to look at any other solution,” said O’Sullivan. “But as we know, in business, if you stay still, you’re actually falling behind.”
Continuous improvement is built into standards like ISO 9001 and ISO 13485. Embracing new tools and more connected ways of working isn’t about change for its own sake, it’s about staying resilient, scalable and competitive.
Turn quality into a strategic advantage with an integrated eQMS
Quality conversations need to focus on how organizations view quality overall. “Quality will always have a cost,” noted O’Sullivan, “but the smart companies turn that cost into a competitive advantage and look at new ways of doing things as a way of doing that, such as an eQMS”
By improving visibility, reducing risk and enabling proactive decision-making, an integrated eQMS helps quality teams move beyond putting out fires and into a strategic role. When quality is managed well, it supports growth, protects reputation and strengthens customer trust.