QualityPro

5 Ways QMS Software Will Transform Your Food Manufacturing in 2025

Chirag Panjwani on May 8, 2025

QMS Software Trends for Food Manufacturing in 2025

Introduction

We are all aware that the food industry works with perishable products that directly impact the health and lives of those consuming them. Even the slightest lapse in product quality can lead to serious consequences such as contamination or illness. Therefore, manufacturers must uphold the highest quality standards before releasing any product to the market. 

But the story doesn’t end here. The food industry constantly faces an evolving set of challenges—complex global supply chains, rising consumer expectations, food safety concerns, and ever-tightening regulations. Fortunately, technology has stepped in to support food manufacturers, and leading the way is quality management software. 

This blog explores the top trends of food manufacturing quality management system and how a food quality management software is becoming a game-changer in 2025. 

Overview

Food production is one of the oldest yet most complex and fast-growing manufacturing sectors. It operates on razor-thin margins, navigates labor challenges, and handles perishable inventory with tight shelf lives. All this, combined with regulatory compliance, makes the food industry one of the most controlled sectors worldwide. 

With increasing cases of foodborne diseases and contamination risks arising from long and intricate supply chains, regulatory bodies like the FDA are tightening standards. They demand greater transparency and traceability throughout the food supply chain. 

Manufacturers are rising to this challenge by turning to QMS for food industry solutions that enable them to maintain food safety, meet evolving compliance requirements, and strengthen overall product quality. 

A robust food quality management system like QualityPro is no longer a luxury—it’s a necessity. 

Benefits of Using Quality Management System in Food Industry 

A modern QMS software for food industry provides key functionalities including Document Management, Change Management, NC and CAPA, Training Management, Audit Management, Complaint Management, and Inspection Management. These features allow manufacturers to centralize, streamline, and automate every quality-critical process. 

Additionally, implementing a robust QMS not only enhances food safety but also fosters a culture of continuous improvement across departments. It empowers cross-functional teams to collaborate using standardized workflows and shared data. This means fewer silos, better coordination, and faster decision-making—all vital for food businesses navigating evolving customer expectations and global standards. 

As digital transformation continues to redefine manufacturing, forward-thinking food businesses are leveraging advanced food QMS software to gain real-time insights, reduce manual work, and eliminate redundant documentation. This digital-first approach not only increases efficiency but also ensures audit readiness and traceability across the entire supply chain. 

5 Ways QMS Software Will Transform Your Food Manufacturing in 2025

1. Following Compliances and Regulations 

Compliance is non-negotiable in food manufacturing. Adhering to international standards, HACCP guidelines, and local regulatory mandates manually is error-prone and time-consuming. QMS software for food manufacturing simplifies this by automating compliance tracking, audit trails, and documentation. 

By leveraging eQMS Software, manufacturers ensure their final product meets all necessary requirements—minimizing legal exposure and penalties. 

2. Preserving Food Safety and Quality 

Consumers today want to know where their food comes from, how it’s made, and that it’s safe to consume. This demand for traceability and transparency makes trends in quality management for food manufacturing more critical than ever. 

A modern food manufacturing software enables manufacturers to trace raw materials, monitor critical control points, and ensure food safety across the supply chain. Real-time insights and digital documentation help ensure products meet desired quality levels at every stage. 

3. Syncing with the Go-Green Mission 

Sustainability is a growing focus in the quality management trends in food and beverage industry. By reducing food waste, minimizing rework, and automating quality records, a food quality management system supports your organization’s green goals. 

The software digitizes key processes—eliminating paperwork and enabling access to critical data on a centralized, secure platform. This leads to lower environmental impact, higher productivity, and improved quality culture. 

4. Determining Issues and Fixing Them Permanently 

Small quality issues, if left unresolved, can cause major disruptions and brand damage. For example, mismatched ingredients or allergens not declared on labels can be catastrophic. 

A QMS for the food industry identifies non-conformances, tracks root causes, and implements corrective and preventive actions (CAPA) to ensure issues are not repeated. The system ensures consistent product quality and regulatory compliance by solving problems at their core. 

5. Improving Supplier/Vendor Relationships 

Suppliers play a major role in maintaining product quality. A comprehensive QMS software for food and beverages industry helps manufacturers evaluate, monitor, and improve supplier performance. 

It tracks supplier certifications, previous audit results, delivery consistency, and more—all in a centralized location.

Whether it’s a small bakery or a dairy processor, managing supplier quality efficiently is critical, and QualityPro is also highly adaptable, making it a suitable solution for various sectors within the food industry, including specialized needs like those addressed by a QMS for dairy industry. 

How Can the Food Industry Benefit from QualityPro Software?

QualityPro is one of the most trusted QMS software for food manufacturing businesses that want to scale without compromising quality. 

It supports organizations in complying with global standards (like ISO 22000, FSMA, BRC) while improving operational efficiency and profitability. 

This web-based quality management software provides end-to-end visibility into the production cycle—ensuring quality, safety, and compliance are maintained across every stage, from raw materials to distribution. 

Key Modules Included

  • Non-Conformance Management – Captures, tracks, and manages non-conformances and root cause analysis. 
  • CAPA Management – Corrects and prevents quality-related issues with verification of effectiveness. 
  • Complaint Management – Manages customer complaints from logging to closure. 
  • Training Management – Tracks and automates employee training programs. 
  • Change Management – Controls, documents, and streamlines change processes. 
  • Document Management – Manages all critical quality documentation. 
  • Compliance Management – Ensures alignment with food safety and quality regulations. 
  • Risk Management – Identifies and mitigates risks affecting food production. 
  • Audit Management – Schedules, performs, and records internal/external audits. 

Upsides of QualityPro’s Food Quality Management System

QualityPro – One of the best QMS system software for the food industry that enables food manufacturing organizations to achieve the highest possible levels of quality, while maintaining production efficiency and profitability. 

Furthermore, it makes it simpler for producers to comply with regulatory standards by providing end-to-end visibility and traceability. 

QualityPro software for total quality management in the food industry is a closed-loop quality system. It includes a variety of standard and advanced features that allow food businesses to manage all aspects of product quality, safety, and compliance—from production to distribution across the supply chain. 

To Sum Up

In 2025, QMS software trends in food manufacturing industries are accelerating digital transformation. A smart, centralized, and agile QMS like QualityPro empowers food manufacturers to ensure safety, achieve compliance, and build a resilient, trusted brand. 

Whether it’s dairy, bakery, seafood, or beverages, modern food producers need integrated, intelligent systems like QualityPro to thrive. 

Discover how a QMS for manufacturing can help you lead in quality, not just comply. 

Choosing the Best QMS Software for Biotechnology Industry 

Chirag Panjwani on April 24, 2025

Best QMS Software for Biotechnology

In the biotechnology industry, innovation drives advancements at a breakneck pace, rapidly transforming the healthcare industry, among others, for the better. However, this growth has perennially come with increased challenges and complexities. And how exactly can the biotechnology industry cope with them in the modern times? 

Read this blog to figure out how you can choose the best QMS software for your biotechnology business to overcome complexities and ensure success. 

Overview 

Innovation is one thing you would always associate with the biotechnology industry. In fact, it is this innovative side of the industry that has played a major role in helping it expand to reach to the heights it has, today. However, it is not innovation alone that has driven this industry. 

If innovation is important, so is precision. When you talk about biotechnology industry, you are talking about sensitive research in the areas of new drug development, improved agricultural practices, and regulatory and environmental stability, among others. 

Add the pressure to reduce time to market, deliver safe & effective products, and address the lack of cross-functional visibility, and you have a whole lot of challenges and growth-related complexities on your hands. 

In such scenario, quality management isn’t just a choice for biotechnology businesses. It’s a necessity. 

A biotechnology quality management system, or a QMS software tailored for the biotech industry can help the businesses with majority of the things, if not all, mentioned above. For starters, it can help the biotech manufacturing businesses build a culture of quality across their organization, which in turn can address most challenges and complexities. 

To understand this, let’s consider the scenario of a biotech organization which is operating without a QMS. Let’s see what challenges they face in the absence of such system, and how its presence can make them a better operator. 

Comparison of Biotechnology QMS Software Usage vs Non-usage

Data and Document Chaos 

Critical documents such as the Standard Operating Procedures (SOPs), manufacturing batch records, training logs, etc. are scattered across various platforms or spreadsheets, in the absence of a dedicated QMS with document management system (DMS) in the biotech industry. This can lead to serious operational inefficiencies such as errors lost time, and even compliance challenges. 

These issues can be effectively addressed with a QMS which comes with integrated DMS. Such a system can streamline their operations by offering all the stakeholders access to a secure and centralized platform where they can manage the SOPs and other critical documents, and get up-to-date information.  

Among other things, it offers electronic document control with version history, and role-based access, which eventually facilitates compliance, reduces redundancies and errors, improves traceability, and enhances the organizational productivity. 

Regulatory Non-Compliance and Audit & Inspection Inefficiency 

It is a no-brainer that industries such as biotech are heavily regulated due to the critical safety and efficacy concerns tied to their products and processes. And in such industries, adherence to strict standards such as the FDA (Food and Drug Administration), ISO (International Organization for Standardization), and EMA (European Medicines Agency), among others, is critical. But, in the absence of an effective QMS, biotech organizations struggle to meet these stringent requirements, which leads to serious risks such as failed audits and product recalls.

However, a good QMS system, with its automated workflows and audit trails aligned with FDA, ISO and other standards, streamlines compliance and ensures that the biotech manufacturing organization is always inspection-ready. Also, through its inspection management feature, it offers organized checklists, templates, and inspection plans to standardize QC tests and expected outcomes. 

Together, they create a robust foundation for audit preparation, supporting all types of audits, and thus helping biotech organization in confirming adherence to set standards and assuring ongoing quality enhancement. 

Disabled Change Management 

In the absence of a quality management system software for biotechnology with change management functionality, biotech companies often encounter significant challenges in managing change. They fail to record change requests arising from different sources, say audit findings for example. This makes it difficult to trace their origin and/or evaluate their impact.

Additionally, this lack of traceability makes the process of tracking lifecycle of changes right from their initiation to implementation, error-prone and cumbersome. 

However, a good biotech QMS software can help address these issues with its dedicated change management function. Furthermore, it can offer a systematic approach to change management, facilitating process modifications initiated due to changes, while ensuring the change gets communicated across teams in a consistent manner so that there are no quality issues or uneven practices.

Unregulated Risk Management 

In the absence of a QMS software, biotechnology companies suffer with a fragmented risk management process, which is severely prone to oversight and inefficiency. The companies find it extremely difficult to identify, analyse, and address different types of risks, such as non-compliance or safety concerns, in the absence of a centralised system. This delay in identification of potential hazards increases the likelihood of regulatory penalties or compromised product quality. 

But a sound QMS for biotech companies with risk management module provides tools to systematically identify, assess and mitigate risks while maintaining detailed records. Its centralized platform enables proactive monitoring of potential issues by offering a consolidated view of critical risk information, empowering the biotech companies to assure their stakeholders that regulatory compliance is maintained, and legal complications are avoided, at all times. 

Ineffective Issue Resolution 

In the absence of a QMS system, biotech businesses struggle to efficiently record the events of non-conformances (NCs), or address the recurring issues. Incomplete or incorrect documentation and disorganized workflows prevent them from making corrective and preventive actions (CAPAs), which in turn prevent them from meeting regulatory standards or achieving other operational objectives. 

A good QMS software for biotechnology industry with NC and CAPA management feature streamlines quality issue resolution and ensures regulatory compliance. While NC management automatically logs non-conformance events and links them to the root causes, CAPA management uses structured workflows to document and track corrective actions with approvals and evidence. These features help biotech businesses such as pharma businesses prevent recurring issues, reduce risks, and maintain compliance. 

How to Choose the Best Quality Management Software for Biotechnology?

If you have stayed with us this far, you likely have a fair idea about what to look for in your prospective biotechnology QMS software, which is best suited for your biotech business. The capabilities discussed earlier, along with some additional features such as Training Management and Complaint Management, comprehensively address the quality management needs of your biotech manufacturing operations.

Additionally, choosing the right QMS for biotech companies requires careful consideration of other few key criteria. You must look for a system that’s tailored for your biotech workflows, and not one that’s adapted from another industry. It should be scalable, must offer ease of use, and should be from a vendor that provides robust support, and training, to maximize your investment. 

QualityPro by TecWork: Best QMS Software for Biotechnology Industry

This brings us to the concluding part of this blog, where we reveal the best QMS for your business in biotechnology industry. Hands down, it has to be QualityPro by TecWork Global Business Solutions.  

QualityPro comes loaded with everything mentioned above, and more, providing your business with a competitive edge and a strategic advantage that drive innovation and success. A modern and feature-rich solution, it not just covers your business’ quality management needs for today, but future-proofs your business for the needs of tomorrow as well. 

Ready to take the next step? Feel free to connect with our sales team to schedule a demo and learn more about how our QMS software can benefit your organization. 

Top 10 Quality Management System Trends to Watch in 2025 

Chirag Panjwani on April 17, 2025

Manufacturing QMS Software Trends in 2025

Introduction

According to market analysis, the global quality management software industry is projected to exceed USD 15 billion by 2030, with an annual growth rate of over 10%. 

This rising curve reflects how crucial it has become for manufacturers to adopt quality management software solutions that are not just compliant but also agile, scalable, and intelligent. 

The post-pandemic era triggered major operational shifts. Today, manufacturers are not only enhancing product quality but also reshaping their digital infrastructure with QMS system software that brings better traceability, reduced waste, and optimized performance. 

A modern quality management system in manufacturing industry does far more than track defects — it supports continuous improvement, supplier collaboration, and strategic quality decisions across the entire value chain.

And in this transformation, 2025 is expected to be a pivotal year. Here’s a look at the QMS trends in the manufacturing industry that will shape quality strategies this year. 

Emerging Quality Management Systems (QMS) Trends for 2025

Quality Management Software (QMS) Trends for 2025

1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) in QMS

The incorporation of AI and ML into QMS is revolutionizing how manufacturers approach quality control. 

These technologies facilitate predictive analytics, enabling organizations to anticipate defects before they occur and implement corrective actions proactively. AI algorithms can analyze vast datasets to identify patterns and anomalies that might elude human inspectors, thereby reducing the incidence of defects and rework. 

This proactive approach not only enhances product quality but also leads to significant cost savings. 

Moreover, AI-driven QMS solutions can automate routine tasks, freeing up human resources for more strategic activities. As AI and ML technologies continue to evolve, their integration into QMS will become increasingly sophisticated, offering even more robust tools for quality management. 

2. Embracing Cloud-Based Quality Management Systems

The shift towards cloud-based QMS solutions is gaining momentum as manufacturers recognize the benefits of scalability, flexibility, and remote accessibility. 

Cloud-based systems allow for real-time data sharing across multiple locations, facilitating better collaboration and faster decision-making. This is particularly beneficial for organizations with geographically dispersed operations. 

These solutions come with lower upfront costs compared to traditional on-premises systems and offer enhanced security features. As remote work becomes more prevalent, the ability to access QMS data from anywhere becomes a significant advantage, making cloud-based solutions essential for modern manufacturers. 

Additionally, many manufacturers are turning to robust eQMS Software to manage documents, CAPAs, training, and audits — all within a secure, centralized cloud environment. 

3. Focus on Environmental, Social, and Governance (ESG) Compliance

Sustainability and ethical practices are now central to quality management strategies. Manufacturers are integrating ESG metrics into their QMS to monitor and improve their environmental and social impact. 

This includes tracking carbon emissions, ensuring fair labor practices, and maintaining transparency in sourcing and production. By embedding ESG considerations into their quality strategies, companies can enhance their reputation, meet regulatory requirements, and appeal to eco-conscious consumers. 

Operational efficiencies gained through ESG compliance also result in cost savings and better risk management. 

4. Adoption of Internet of Things (IoT) for Real-Time Quality Monitoring

IoT integration in manufacturing processes enables real-time data collection on equipment performance and product quality. 

Sensors embedded in machinery detect deviations from standard operating conditions, allowing for immediate corrective actions. This reduces downtime, prevents defects, and enhances operational efficiency. 

The data collected also supports trend analysis and continuous improvement, making IoT a vital component of smart, responsive quality management. 

5. Implementation of Digital Twins for Process Simulation

Digital twin technology creates virtual replicas of physical assets or processes, allowing simulation and analysis without disrupting real operations. 

Manufacturers can test different scenarios, identify potential issues, and optimize processes before implementation. This leads to more efficient and effective quality management with reduced trial-and-error costs. 

By using digital twins, companies can ensure better process validation, improved product design, and minimized quality risks. 

6. Strengthening Supplier Quality Management

With complex and globalized supply chains, managing supplier quality is increasingly important. Robust supplier quality management includes regular audits, performance evaluations, and improvement initiatives. 

Ensuring suppliers meet high-quality standards maintains product consistency, reduces defects, and fosters reliable partnerships. 

Clear communication of expectations and ongoing monitoring are key to effective supplier quality practices. 

7. Enhancing Cybersecurity Measures in QMS 

As digital QMS platforms store sensitive data, cybersecurity becomes critical. Manufacturers are investing in measures like encryption, multi-factor authentication, and regular security audits. 

Robust cybersecurity ensures data integrity, prevents breaches, and supports regulatory compliance. With the rise of digital transformation, secure QMS systems are a necessity. 

8. Promoting a Culture of Quality Within the Organization

Quality isn’t just about systems—it’s about people. Embedding a culture of quality across the organization is essential for long-term success. 

Modern QMS platforms support this by enabling better SOP adherence, real-time task tracking, and quality performance visibility. 

When quality becomes a shared responsibility, outcomes improve at every level. 

9. Strategic Training and Upskilling Through QMS Platforms

Training is key to consistent quality. In 2025, more organizations will use QMS software to track certifications, deliver digital learning, and assess employee readiness. 

Effective training reduces human error, boosts SOP compliance, and builds a workforce that supports continuous improvement.  

By investing in the right QMS system software today, manufacturers can unlock long-term advantages that go beyond compliance. Organizations that align quality processes with digital transformation are not only better equipped to adapt to change—they lead it.

10. Transition to Unified QMS Platforms

Disconnected tools create data silos and inefficiencies. Manufacturers are shifting to unified QMS solutions that bring together CAPA, non-conformance, audits, training, and document control. 

Platforms like QualityPro offer integrated environments that streamline operations, improve communication, and enhance decision-making. 

These platforms provide real-time access to reliable data, ensuring all stakeholders are aligned and informed. 

Final Words

The QMS landscape is evolving rapidly. To remain competitive in 2025, manufacturers must align with these emerging trends and invest in future-ready solutions. 

By leveraging technologies like AI, IoT, digital twins, and cloud-based platforms—and embedding ESG and quality culture into their strategies—companies can achieve operational excellence and customer satisfaction. 

As manufacturers move toward unified systems, selecting the best QMS software for manufacturing becomes a strategic decision. Integrated platforms help ensure compliance, minimize risk, and provide a competitive edge in fast-paced markets. 

In 2025, quality can no longer be an isolated department. It is deeply integrated with sustainability, cybersecurity, training, and data. Businesses that embrace this shift are building resilient, efficient, and trustworthy brands. 

The future of manufacturing belongs to those who treat quality not as a checkbox, but as a strategic driver of growth. Those who implement a comprehensive, cloud-based, and AI-augmented QMS will reap the benefits of improved performance, stronger customer satisfaction, and sustainable success in a competitive market. 

How to Choose the Best QMS Software for Your Dairy Business?

Chirag Panjwani on March 31, 2025

Quality Management Software for Dairy Production

Non-conformities are Bound to Happen!

Have you ever had your milk curdle because you accidentally left behind a tiny trace of detergent in the vessel? A seemingly small mistake can ruin the entire milk.

Now, imagine this happening on an industrial scale. In large-scale milk processing, even minor inconsistencies or non-conformities can pose serious risks.

For milk manufacturers, ensuring product quality is a constant challenge. Contamination can occur through physical, chemical, or microbiological hazards, as well as through processing equipment. With so many potential risks around non-conformities are bound to happen.

That said, maintaining milk quality from processing to delivery is critical for dairy processors. But how? How can dairy manufacturers safeguard the quality of their products throughout the production process and beyond?

The Need for Quality Management Software in Dairy Production

Ensuring product quality in dairy production requires strict adherence to standardized processes across the organization. However, a critical challenge remains: Who will drive a culture of standardization while ensuring compliance at all times?

This is where Quality Management Software (QMS) for Dairy Production plays a vital role. It helps dairy manufacturers maintain process consistency, adhere to regulatory standards, and ensure product quality from sourcing to distribution.

However, the bigger challenge lies in selecting the right food QMS software. To put it simply—just as you check essential details like price, manufacturing date, and expiry date before purchasing a packet of milk, you must also evaluate key features and capabilities before choosing a Dairy Quality Management Solution.

Steps to Selecting the Best QMS Software for Dairy Industry

Steps to Selecting the Best QMS Software for Dairy Business

Here’s a comprehensive guide to help you make an informed decision.

Step 1: Identify Your Business Needs

The selection of any software or tool primarily depends on the specific needs of a business. For the dairy industry, it is necessary to determine what type of quality-related challenges your operations are facing.

Do you need standardisation, better traceability, automated compliance, or improved supplier quality checks? List out your priorities before shortlisting software options. List down modules and capabilities that are needed to meet the chalked-out requirements.

Additionally, it is required to identify all the relevant guidelines, quality standards, and industry regulations to which your company must comply.

Step 2: Compare Different Vendors

Look at various QMS providers and compare their offerings. Consider aspects like:

  • Industry experience (Do they specialize in the dairy and food industries?)
  • Customer reviews & testimonials (This gives insights into the real-world experiences of other users)
  • Scalability (Can the software grow with your growing business needs?)

Additional Information to Ask for From a Vendor

  • Request for Information- It is a document containing information related to products, services, features, and pricing models.
  • Request for Quotation- It is a document requesting specific pricing information from the potential vendors for a defined set of product features, implementation strategies, no. of users, etc.
  • Request for Proposal- It is a document sent to a list of shortlisted vendors asking to submit proposals explaining how they’re going to meet the requirements outlined by the proposal-requesting company.

Step 3: Request a Demo & Trial

Before finalizing, request a demo to see the software in action. Many vendors also offer free trials, allowing you to test usability and functionality before making a commitment.

The demonstration should be justifiable allowing you to assess the eQMS software on every front, including user interface, functionality, and compatibility with the company’s goals and objectives.

Carry out multiple meetings and ask if they could offer you a trial to explore and ensure that you get all the specific modules you are looking for.

Moreover, it is recommended to ask the shortlisted vendor to provide a demonstration tailored to address the unique cases/scenarios that are relevant to the company’s daily operations. For example, a dairy manufacturer may request a demonstration of how the dairy QMS software ensures milk quality control throughout the production cycle.

This could include features like real-time monitoring of pasteurisation parameters, automated quality checks for fat and protein content, and compliance tracking with food safety standards like FSMA and HACCP.

Step 4: Check Pricing & Support Services

A good QMS system should fit within your budget while offering robust customer support.

Consider:

  • Upfront costs vs. subscription models- Ensure that the proposed pricing from the vendor’s end aligns with your company’s budget and provides value for money.
  • Training & onboarding support- Discuss the level of support services your shortlisted vendor will provide in terms of availability and response times for addressing technical issues.
  • Implementation Timeline- Decide a realistic timeline for the implementation of the new QMS software, considering factors such as data migration, training, system configuration, etc.
  • Future Updates- Assess the future roadmap of your vendor for regular updates ensuring that your system remains aligned with the evolving market needs.

What to Look for When Choosing a Dairy Quality Software Solution?

  • Modules & Capabilities that meet the organization’s need- a comprehensive solution is always a better choice. As opting for stand-alone best-of-breed solutions may later lead to integration issues and data isolation.
  • Security & Authentication with Encryption and Role-Based Controls
  • Comprehensive Audit Trails with Time-Stamped Records
  • Intuitive & User-Friendly Interface for Seamless Navigation
  • Cloud-Enabled Accessibility with Web-Based Capabilities
  • Efficient Document Management for Centralised Control
  • Proactive Risk Assessment & Mitigation for Compliance Assurance

Get the Competitive Advantage with the Best QMS Software for Dairy Industry

Selecting the right QMS software for dairy business is a crucial decision that impacts product quality, regulatory compliance, and overall efficiency.

By focusing on essential features that support quality, compliance, automation, and ease of use, you can invest in a solution that helps your business thrive.

Ready to take your dairy quality management to the next level? Explore QualityPro—a robust Quality Management Software for dairy production developed by TecWork solutions.

The Importance of Change Control in the Pharmaceutical Industry

Chirag Panjwani on February 12, 2025

Change management in pharma industry

‘Complexity’ is one term that is omnipresent in every stage of pharmaceutical manufacturing.  

The entire process—from choosing raw materials to processing them in a controlled environment, packaging without sacrificing quality, and delivering the products—must comply with stringent regulatory standards.  

Adding a layer to this complexity is the occurrence of any change. Change may be in the process, documentation, machinery, facility, vendor, or any other.  Any change brings an array of adjustments, a torrent of confusion and the risk of quality deterioration.  

Here comes the importance of change control in the pharmaceutical industry. It acts as a shock absorber on the bumpy road of the pharmaceutical business. We’ll dig deep into the importance of change control, but first, let’s understand it better.

What is Change Control in Pharma?

Change control in pharma is a systematic process that involves careful evaluation, documentation, and approval of changes to pharmaceutical processes, equipment, facilities, suppliers, documents, change management system, SOPs, and even personnel.

Change control intends to minimize risk and ensures that any change is smooth throughout the organization without negatively affecting the quality, efficacy and safety of the products. Moreover, change control ensures that the outcome is as compliant as its predecessor.

Generally, changes occur in the following areas:

Production

  • Change in location
  • Change in equipment
  • Change in batch size

Engineering

  • Change in equipment
  • Change in facility area
  • Change in part of equipment

R&D

  • Change in specification of raw materials 
  • Addition/deletion of raw materials in the product 
  • Change in quantity of raw materials in a product 
  • Change in shelf life 
  • Change in environmental conditions 
  • Change in storage conditions 
  • Change in stability protocols

Quality Control

  • Change in method of analysis
  • Change in hardware /software of the analytical instrument
  • Change in stability protocols
  • Change in specification of in-process/ intermediate materials

Quality Assurance

  • Change in the sampling plan 
  • Change in documentation/SOPs 
  • Change in the validation process

Cleaning process

  • Change in cleaning steps 
  • Change in cleaning aids 
  • Change in cleaning agents

The above list is just suggestive and not exhaustive. The list is mentioned to give you a fair idea of the scope of changes in the pharmaceutical manufacturing industry.

Cycle of Change Control:

Cycle of change management
  • Step 1– Change originates
  • Step 2– Submit a request for change  
  • Step 3– Review the change request 
  • Step 4– Impact assessment 
  • Step 5– Approval 
  • Step 6– Implement change
  • Step 7– Review and reporting 

Types of Changes:  

Changes are broadly divided into two groups:  

Unplanned Change:

Any unexpected modification that requires immediate action is termed as Unplanned Change. These are generally the result of any unforeseen event, like equipment failure, deviation from set procedures, etc. 

Planned Change:

An intentional and pre-defined change or modification that is implemented with proper evaluation and authorization falls under the category of Planned Change. These changes are carefully considered, and every dimension of safety, efficacy, and quality is assessed before implementation.

Importance of Change Control in the Pharma Industry:

Change control importance in pharma industry

On a macro level, change control is important to pave a smooth path for change in the organization. It ensures that changes don’t trigger quality loss, safety threats, or efficacy deterioration.  

Let us broaden the lens and see the importance of change control in the pharmaceutical industry.  

Regulatory Compliance:

Pharmaceutical manufacturing organizations must adhere to various national and international compliance norms set by regulatory bodies like FDA, EMA, DHA, CDSCO, MHRA, etc.

Change control ensures that the organizations meet the guidelines laid by these bodies and adhere to cGMP (Good Manufacturing Practices). 

For example: When the need for a change arises, it is first evaluated and approved. A proper plan is devised and concerned stakeholders are informed about the change. The whole process is documented and the documents in respective departments are also modified accordingly.

Thus, the whole process ensures transparency, and accountability besides fulfilling the documentation requirements necessary for regulatory compliance.   

Risk Management:

Change control helps in mitigating risk in advance. By proactively evaluating the impact of the proposed change, it can foresee the risks. This foresightedness can help manage risks with due care and dampen their impact on the organization.  

Documentation and Accountability:

Meticulous documentation of all changes is the key process involved in change control. Additionally, it involves documentation of the rationale behind the change and decisions made throughout the evaluation process.

The whole documentation serves as a transparent record for various regulatory requirements. These documents identify the approving authority, fostering accountability within the organization. 

Continual Improvement:

Improvement is at the core of any proposed change in an organization. This improvement can be in the processes, manpower, equipment, or any other.

Change control helps to bring improvement in a regulated and systematic fashion within pharmaceutical organizations.  

For example, if a pharmaceutical organization upgrades a tablet coating machine, it does so with the intention of offering better precision and efficiency.

Change control not only results in an upgraded machine, but it also affects (improves) the overall processes related to a new machine’s upgrade such as its working procedure, material required, lead time, resources, SOP, and so on.

Product Consistency:

Change control aids in maintaining product quality and consistency. Pharmaceutical manufacturing is critical, and even a slight change can deviate the final product from the set standard.

By implementing a robust change control system, organizations can ensure that every change is evaluated, documented, and tested to maintain product consistency. 

Operational Efficiency and Cost Savings:

By managing changes systematically, organizations can avoid downtime or production delays. Change management can also help avoid regulatory penalties and product recalls, thereby protecting the company’s image and financial health. 

Better Communication and Coordination:

A change control system promotes communication and collaboration among various departments of the organization. It ensures that every department is aware of the change, its impact, and implementation strategies.

If the need arises, departments can raise issues, suggest alternatives, or voice their apprehensions to foster better communication and coordination within the organization for improved decision-making. 

These are some of the important functions of change control in any pharmaceutical industry. Let us now take a bird’s eye view over ideal practices to make the change control effective.

Best Practices for Effective Change Control

To implement an effective change control process, pharmaceutical companies should consider the following best practices: 

  • Establish Clear Procedures 
  • Involve Key Stakeholders 
  • Conduct Thorough Impact Assessments 
  • Maintain Detailed Documentation  
  • Review and Approve Changes  
  • Monitor and Review Changes Post-Implementation   

While adopting these best practices is crucial, leveraging technology can further enhance the efficiency and accuracy of change control management.

Role of QMS Software in Streamlining Change Control Management:

Traditionally, change control is done manually using paper-based systems, leading to errors, repeated work, and delays in updating everyone involved.  

An Electronic Quality Management System (eQMS) offering built-in support for change control is the key. Change Control management software can digitize the entire change process and centralize all the information in one system.

The system helps record, manage, review, verify, validate, approve, and update the change to all stakeholders thereby meeting compliance.

Key Functionalities of the Change Control System are:

  • Change Request Initiation: Initiate and document change requests for processes, documents, or systems.
  • Impact Evaluation: The module evaluates the potential effects of changes on processes, compliance, and operations.
  • Automated Workflow: It automates the entire change management process, from request initiation to implementation and closure.
  • Cost measurement: Evaluate the proposed change by measuring the costs associated with the change.
  • Compliance Assurance: It ensures adherence to regulatory standards by maintaining a detailed audit trail for all changes.
  • Collaboration and Communication: Help Identify departments affected by the change intimating them of the same through alerts & notifications.
  • Documentation: Maintains a centralized repository for all change-related documentation.
  • Verification and Closure: Ensures changes are verified post-implementation for effectiveness before closure.
  • Training on Changes: identifies who needs to be trained for the change and schedules the training on same.

If you are a pharmaceutical organization, looking forward to injecting electronic capabilities of change control, then QualityPro QMS for pharmaceutical is software you should look forward to. 

To know more about it, write to us at sales@tecwrk.com.