Change is inevitable in manufacturing. Controlling change effectively distinguishes industry leaders from quality-deficient, recall-plagued, and regulatory-troubled companies. As organizations are increasingly pressured to reduce costs while maintaining high levels of product quality, the drive to implement change plans with speed has never been greater. However, experience in highly regulated sectors indicates that a formal, systematic approach to change control is not only a regulatory requirement but also a business imperative.

The price of unmanaged change

When organizations implement changes without proper controls, they often fail to foresee the full cost of nonquality. Consider the following:
• A single-person product recall might cost a manufacturer $600 million, according to McKinsey. The medical device market alone incurs as much as $5 billion annually in recall expenses.
• A 2024 study shows 37% of pharmaceutical recalls are attributed to impurities and contaminants, and 28% have problems with control.
• Class I recalls, those with significant health consequences, are 14% of all activities and affect about 400,000 units per incident.

These figures underscore a bedrock fact: The value of implementing effective change control systems is high, and the cost is minimal compared to the cost of failure.

Learning from manufacturing challenges

A recent systematic review of drug change management indicates that validated changes shouldn’t compromise the quality, safety, or strength of drug products. Disregarding this can be lethal. For example, reformulating drugs without proper testing can lead to dosing errors, putting patients at risk of serious harm.

Case study: The sterilization supplier crisis

In 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. discovered that an industry supplier had falsified a sterilization record. Although the devices had been sterilized, the sterilization process couldn’t be guaranteed to be adequate. The MHRA issued warnings to 88 medical device manufacturers that had used this supplier’s services and required full risk assessments on affected products.

This incident illustrates how change control weaknesses can cascade throughout supply chains. More important, it illustrates why change control must reach beyond your organization’s walls to key suppliers and partners.

Digital transformation risks

A hypothetical example involves a midsize pharma company hit by a ransomware attack. Over three months, the attack encrypted most of the company’s networked devices and infected servers. This scenario demonstrates how digital transformation projects, if not properly coordinated through change control procedures, can create new vulnerabilities even as they aim to improve processes.

Key principles for effective change control

Industry experts recommend two proven approaches to manage changes in manufacturing.

The ‘lift and shift’ approach: Existing processes are relocated before any technology or operations enhancements are installed. This approach isolates variables and keeps things simple at transition.

Incremental change management: Each individual phase of transformation is completed and validated before moving to the next phase. This approach prevents cumulative risk caused by the simultaneous rollout of multiple changes.

The basic rule of both techniques is simple but commonly broken: Don’t change more than one variable at a time. Despite this recommendation, organizations tend to feel they can shorten project timelines by implementing a few changes at once, a decision that often proves problematic later.

Change control in pharmaceutical companies is defined by accurate guidelines and instructions. EudraLex Volume 4 GMP Annex 15 defines change control as a regulated plan through which authorized representatives check changes that may affect validated facilities, systems, equipment, or processes.

ICH Q10 defines the process of change management as a structured procedure to recommend, evaluate, approve, install, and audit changes.

Similarly, FDA 21 CFR Part 211 also recognizes change as procedures that must be written, reviewed, and signed by the responsible quality control personnel. The regulation is equally applicable to medical devices, in-vitro diagnostic, and pharma companies (and other FDA-regulated industries as well).

Changes are typically classified as planned or unplanned. Minor changes with less chance to affect product quality are planned changes, when significant alterations are performed only after thorough analysis and verification. These are critical changes that are likely to affect product quality, safety, or effectiveness. Planned changes can be executed transiently for process evaluation and optimization.

Unplanned changes primarily result from equipment failures or are due to safety needs, customer grievances, or procedural nonconformities.

Effective change control systems share many traits

Clear classification of changes

Changes must be classified correctly to enable appropriate review and approval procedures.
• Minor changes: Little likelihood of affecting product quality, with routine documentation and review required
• Major changes: Require careful analysis and validation before implementation.
• Critical changes: Significant potential to affect product quality, safety, or efficacy, requiring thorough review and validation.

Cross-functional change control committees

Members of effective change control committees would include:
• Quality assurance leadership
• Manufacturing operations
• Regulatory affairs
• Risk management
• IT/digital transformation specialists
• Process engineering
• Supply chain management

Systematic documentation and tracking

All changes must be recorded, and unambiguous procedures written, checked, and signed by authorized staff. These should include:
• Change description and rationale in detail
• Risk assessment and mitigation plans
• Implementation schedule and assignment
• Criteria for success and methods of validation
• Rollback procedures, if necessary

The technology advantage

Digital transformation is revolutionizing change control capabilities. The global quality management software industry is growing rapidly and is predicted to develop at a compound annual growth rate of nearly 13% from 2025 to 2030. Such software must provide:

Predictive analytics—Machine learning algorithms trained in manufacturing process data can anticipate issues ahead of time, enabling proactive instead of reactive change management.

Automated documentation— Computer-generated systems can produce necessary reports and documentation automatically, ensuring consistency and reducing administrative expense for quality teams.

Real-time monitoring—Computer-based quality management systems provide continuous monitoring capabilities, which serve as early warning systems that identify potential problems before they affect customers.

Improved traceability—Computer-based systems enable complete traceability of change over their lifetime, simplifying root cause analysis and continual improvement.

Measuring success with key performance indicators

Organizations must track specific measures to gauge their change control initiatives’ effectiveness. These key performance indicators (KPIs) include:
• Implementation accuracy—changes implemented with no deviations
• Approval cycles—elapsed time from requested change to approved implementation
• Cost of quality metrics—total cost of quality-related activities vs. cost of nonquality
• Deviation rates—process deviation incidences in change stages
• Cycle time—elapsed time from change initiation to results validation

A three-phase approach to implementation strategy

Effective implementation of change control follows a systematic approach shown in the chart below.

Phase 1: Digital foundations—Develop cloud-based QMS systems that provide the underpinnings for systematic change management. This includes standardized workflows, document control systems, and core reporting functionality.

Phase 2: Smart analytics—Adopt AI-powered risk assessment systems that can compare proposed changes to the past and predict potential outcomes. Phase 2 provides predictive capabilities and additional decision-making functions.

Phase 3: Intelligent automation—Enforce full AI integration of change assessment, like automated risk scoring, suggested mitigation strategies, and best practices implementation sequencing.

The culture club of change control excellence

Technology alone won’t guarantee change control. Culture also has a key role to play. To nurture a culture of change, companies can implement the following.

Invest in training and engagement: Everyone at all levels should know not just the procedures, but also the underlying principles and rationale behind change control. Training sessions must cover technical specifications and real case studies.

Foster active risk management: Encourage teams to raise issues early and not let them become longer-term problems.

Balance speed and thoughtfulness: Change control requires introducing process steps, but organizations can streamline these processes to shed unnecessary delays without giving up completeness. The goal is to be “right the first time” instead of “fast and fixed later.”

Global standards and best practices

Organizations operating across jurisdictions must operate with diverging regulatory needs while seeking to deliver similar quality standards. International standards provide helpful guidance:
• The International Council for Harmonisation lays out globally accepted guidance for regulated sectors.
• ISO 9001 quality management principles apply worldwide across all sectors.
• Industry-specific standards provide additional guidance for specific applications.

Future trends and implications

The context of change control continues to develop quickly, given expectations for the medtech market to reach $886.68 billion by 2032, and the pharma market expanding at a projected 4.71% annually, reaching $1.45 trillion by 2029.

Artificial intelligence integration

The global pharma AI market is expected to grow from $1.94 billion in 2025 to $16.49 billion in 2034 (27% CAGR). In addition, just under 80% of pharma CEOs expect intelligent automation to significantly effect the industry in five years. AI adoption in quality management is on the rise, with 95% of pharma companies investing in AI capabilities. Furthermore, 80% of pharma professionals currently use AI for drug discovery.

This trend is extending to all sectors of manufacturing across industries. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are developing AI projects. But AI/ML aren’t yet part of GMP guidelines, and it will take some time to deploy them.

Increased regulatory support

In 2024, the FDA finalized guidance for the Advanced Manufacturing Technologies Designation Program, marking a significant agency move toward simplifying pharmaceutical manufacturing modernization. About the same time, the FDA issued draft guidance on Predetermined Change Control Plans for medical devices, allowing manufacturers to request preauthorization for postmarket changes, potentially avoiding the need for a new marketing application or FDA approval.

Supply chain digitization

As supply chains become increasingly digital and interconnected, change control systems must include changes to suppliers and their potential effects on quality.

The business case for successful change control

Building the right culture and processes around change control not only strengthens internal operations but also safeguards external partnerships throughout the supply chain. The value extends beyond compliance, and it creates a measurable business advantage.

Implementing effective change control systems has measurable business benefits.

Reduced risk: Proper change management reduces the likelihood of quality failures, recalls, and regulatory complaints.

Competitive advantage: Organizations with mature change control can implement beneficial changes quickly and more predictably than competitors.

Regulatory compliance: Controlled change ensures conformity to relevant regulations and standards to prevent penalties and maintain market access.

Operational excellence: Well-managed change processes improve overall operational efficiency and reduce waste.

Innovation: Ironically, formalized change control may accelerate innovation by creating a stable vehicle for experimentation and adoption of innovative ideas.

Conclusion

The quality management landscape continues to evolve at a rapid pace, driven by supply chain complexities, technological advances, and changing market demands. In this environment, the ability to manage change effectively has become a core competency that separates successful organizations from those that struggle with quality issues and operational disruptions.

Organizations able to fight the urge to make multiple changes at once and focus on systematic change management programs increase their likelihood to succeed. By merging established change control practices with new digital technology and AI capabilities, these firms can better manage challenges now while preparing for future growth.

Having an effective change control system is well worth the investment in terms of avoiding risk. Investment drives significant value in promoting operational excellence, improving innovation competence, and securing competitive advantages. As change continues to accelerate, organizations that have strong change control competencies will be well positioned to thrive in an increasingly complex and demanding marketplace.

The future belongs to companies that can balance the necessity for rapid adaptation of manufacturing changes with the seriousness of systemic change management. With the practices and principles outlined in this article, quality practitioners can help their organizations attain this necessary balance and realize the promise of innovation and optimization without jeopardizing what most truly matters—enduring product quality and enhanced customer satisfaction.