QualityPro

Menu

Top 10 Quality Management System Trends to Watch in 2024

Chirag Panjwani on June 2, 2023

According to a report, the global quality management software market size was valued at USD 9.37 billion in 2022 and is expected to record a compound annual growth rate (CAGR) of 10.6% from 2023 to 2030.

The figures clearly indicate that due to the growing consumer awareness and demand for quality, more and more manufacturers are turning towards adopting this digital approach of maintaining “Quality” in their products.

The QMS Software market saw a slump in its growth, during pandemic, owing to financial restrictions. But, since the market has recovered to its original strength, organizations are more vigilant to serve the quality-seeking customers just what they need.

Moreover, the manufacturers are even focused on enhancing sustainability practices into their routine operations with a supreme goal of reducing waste and carbon footprint.

These and many such factors have set the base for QMS trends that will rule 2024.

So, the quality management strategy of the manufacturers seeking one should be based on the trends that are mentioned ahead in this blog.

Top 2023 Trends in Quality Management System

Increased Adoption of Lean Six Sigma-

The combination of these two fundamentally sound methodologies- Lean Manufacturing and Six Sigma, is taking a front stage these days.

Reason? It provides a streamlined framework to businesses to incorporate an improvement strategy focusing on managing

1. The flow of materials and crucial information between the processes,

2. Minimizing waste,

3. Addressing and removing the no-value-adding tasks.

This in turn helps bypass challenges like meeting customer expectations, cutting costs pressures, improving profits, and reducing lead times.

Aren’t these reasons enough to crown adoption of lean six sigma a top QMS trend of 2024.

Adoption of Lean Six Sigma

Growing Cloud Technology-

Businesses, to excel today must have flexibility, scalability, and transparency.

Holding on to the on-premises software solutions with huge infrastructure maintenance cost, slow performance, pending updates, location-dependent services, and much more, could be detrimental.

On the contrary, having remote and faster accessibility to all data, ability to collaborate multi-locations and multi-sites, scalability to new needs and norms and such capabilities ensure business not just survive but thrive in this digital world.

These capabilities are offered by Cloud-Solutions, and this makes it yet another top trend of 2024.

Increased Focus on Supplier Management-

Poor supplier performance impacts an organization’s product quality, finances, time, customer base, brand image in the form of lost sales, costly recalls, penalties for non-conformance, etc.

Thus, upgrading and maintaining the supplier quality—by partnering the suppliers capable of meeting regulatory & safety standards, would be an unavoidable trend to eye on.

Managing Cyber Security Risks-

In the era of tech dominance, cyber risks have become a major concern, specifically for the manufacturers that are data-dependent.

Hence, enhancing security to safeguard trade secrets like formulas/recipes, crucial documents and gaining complete operational control, etc., would be one of the major goals of the manufacturers this year.

More Transparent Production-

Consumers are increasingly interested in knowing about the items they purchase than ever before due to increased concerns about food safety, ethical sourcing, data security, and environmental impact.

“According to research, 94% of consumers are more likely to be loyal to a brand that offers complete supply-chain transparency, while 39% say they’re willing to switch to a more transparent brand.”

As a result, manufacturers will seek to implement robust tracking capabilities across their supply chains. Thus, from inception to consumption, 100% transparency will be a prominent trend this new year.

Prioritizing Quality Culture-

For a successful quality management program, quality culture is of paramount importance.

People often consider that only records, SOPs, and documentation, govern the ideology of “quality.” However, these factors account for 20–30% of maintaining quality.

The quality culture and mentality that you introduce within the organization will ensure that individuals truly adhere to the SOPs, comprehend them, and internalise them.

Hence, in 2024, instilling a culture of quality by deploying a good quality management software that allows the user to do the job right, will be a trend.

Making data-driven decisions-

What separates a thriving business from a declining one is the quality of decisions the management makes. And data proves to be the key to sound decisions.

For this, having a QMS software that offers robust functionalities like real-time view and operational insights of the business, helps manufacturers make data-driven decisions.

More Effective Training Programs-

A successful quality management program not only depends on improving processes using Quality Management Systems, but also enhancing involvement of and upskilling employees.

Hence, to accomplish the goal of delivering high-quality products and services, businesses need to invest in building effective training programs for their employees to reduce the possibilities of error— thus fixing a place in the top trends this year is Training Programs.

Better Audit Preparedness-

With an increase in globalization and technology, the manufacturing sector has become more vulnerable to the risks. Moreover, with time, even the norms and norm-makers have become stringent and stricter.

That said, performing manufacturing audits actually help identify the gaps, gain useful business insights, and improve company’s future performance.

And staying ready for such audits is not just a trend but a good business practice.

A Comprehensive Solution-

The world is coming on a platform called technology. Integrated solutions are the norm. We agree that best-of-breed software have better capabilities, but they come with a potpourri of drawbacks-

  • 1. Inconsistent workflow
  • 2.Increased time in integrating data
  • 3. Extra cost due to multiple implementations & maintenance
  • 4. Disconnected and spilled data 5. Errors and lag in data retrieving

An integrated solution, quite like a QMS with all-essential modules, on the contrary keeps the entire organization on a common platform.

It provides real-time, unified, and precise data without the need for uploads and downloads. These benefits have won a place for an integrated and unified QMS Software in prominent trends this year.

Final Words-

Though the impact of the above-mentioned trends could be different for different organizations but, making the right choice of the solution would be the defining factor in terms of growth & productivity.

One such solution that proves competent to all the quality management requirements even during the changing market trends is the QualityPro.

Being a next-generation, cloud-based software, it helps manufacturers streamline the key quality management processes—ensuring quality throughout the product lifecycle.

Difference between QMS and ERP: Key Aspects and Functionalities

Chirag Panjwani on March 17, 2023

QMS vs ERP system

Comparing QMS Software (Quality Management System) and ERP Software (Enterprise Resource Planning) is akin to contrasting apples and oranges. Both fall into the broader category of business software, yet their functions and importance diverge significantly, crucially enhancing businesses by streamlining operations in different ways.

Discover more about their unique capabilities, distinct features, and interconnectedness. The surprising conclusion might reveal an unexpected synergy between these two essential systems. Keep reading to explore their differences and their surprising connection!

Overview:

Businesses of all sizes and types can use QMS and ERP software. QMS software is crucial for companies that operate in highly regulated environments such as healthcare, aerospace and defense, the automobile industry, food and beverage industry, etc. Since these organizations typically have to abide by quality standards and rules like ISO 9001, they require a software solution to monitor and record their quality processes.

On the other side, businesses of various sizes, industries, and sorts need ERP to automate and streamline their operational procedures from start to finish along the complete supply chain. ERP software can help businesses make better decisions, and boost productivity and profitability to have a unified perspective of their business operations.

However, businesses often get confused if they should implement an enterprise resource planning system or deploy a standalone quality management system. As the features of these systems frequently overlap, there may be discussions among companies who have already implemented both systems over which system best meets a certain functional requirement.

But the key is, when it’s about managing the processes of regulated industries, it’s important for manufacturers to deploy a solution that can oversee quality and is also suitable for their regular business operations, procedures, and outputs. It should be a blend of the quality and their supply chain functionalities.

What is a QMS?

A formalized system that documents processes, procedures and responsibilities for carrying out quality policies and objectives is known as a quality management system (QMS). A QMS helps in organizing and directing an organization’s operations to satisfy the customer and regulatory requirements and continuously enhance effectiveness and efficiency.

Benefits of QMS:

  1. Streamline and automate end-to-end business operations
  2. Centralize data for a single source of truth
  3. Rapid responses to critical business issues
  4. Gain comprehensive business insights
  5. Accelerate company and financial reporting processes
  6. Ensure compliance with legal requirements through enhanced visibility
  7. Unified platform for data storage and integration with shared databases
  8. Optimize stock levels and inventory management
  9. Efficient warehouse management to support operations

What is ERP?

Enterprise resource planning (ERP) is a modular business management software that organizations use to manage day-to-day business activities such as accounting, procurement, project management, human resources, compliance, and supply chain operations, etc. A complete ERP software suite includes enterprise performance management, planning, budgeting, predicting, and reporting on an organization’s financial health.

ERP systems allow for the exchange of data between various business processes and bind them all together. They avoid data redundancy and ensure data integrity with a single source of truth by gathering an organization’s shared transactional data from several sources. The new-gen ERPs are available on different platforms- cloud ERP, on-premise ERP, and hybrid ERP.

Benefits of ERP:

  1. End-to-End Process Optimization: Streamline operations from start to finish
  2. Unified Data Repository: Obtain a reliable single source of truth
  3. Rapid Decision-Making: Prompt responses to critical business issues
  4. Comprehensive Analytics: Deeper insights for informed decisions
  5. Accelerated Reporting: Expedite company and financial reporting
  6. Enhanced Compliance: Maximize visibility to meet legal requirements
  7. Centralized Data Platform: Single platform for data storage and integration
  8. Optimized Inventory: Improved stock levels and control
  9. Efficient Warehousing: Streamline warehouse management operations

Key Functionalities of ERP & QMS:

Here’s more clarity on the type of modules these software offers:

Major difference between ERP and QMS Modules

Difference Between ERP and QMS

Difference between ERP and QMS System

The Potential of Combining QMS & ERP

Disparate systems and quality control procedures can rapidly silo crucial enterprise as well as quality data, resulting in complexity, limiting visibility and standards, both inside and between the facilities.

An ERP solution can enable enterprise integration and meet a variety of manufacturing needs. And a QMS can ensure quality at each step. However, adoption of integration of an ERP system and a QMS, will make it possible for the two systems to communicate with one another and exchange data, seamlessly, reducing duplication and delays associated with manual upload and download.

And so, to compete, expand, and innovate, manufacturers should adopt a cloud-based enterprise resource planning system with quality management features.

  • Integrating the two softwares can help businesses automate quality workflows into operational processes resulting in thorough application of quality processes across the entire supply chain cycle.
  • Improvement in quality and compliance drives the ability to standardize, streamline and simplify processes.
  • Businesses can predict trends and risks on the company by analyzing real-time data stored centrally which will drive them towards continuous improvement.
  • By automating quality procedures, it becomes possible to promote and apply best cGMP practices in all operations that enhances the quality of the final output.
  • QMS and ERP together speed audits and keep manufacturers away from legal obligations and fines without compromising on quality.
  • Streamlining workflows and synchronizing them between quality and manufacturing reduces cycle times, throughput value and resource requirements.

Combining a QMS and ERP system can result in improved data accuracy, better collaboration, increased efficiency, enhanced visibility, and improved compliance. By leveraging these benefits, manufacturers can drive performance improvements, respond more quickly to changing market conditions, focus on innovation, preserve capital and remain competitive in a rapidly evolving industry.

Summarizing thoughts

Understanding the needs of the business and all the associated functional groups is essential to choose the best solution. In light of the needs of the business, the capabilities of the various systems must be assessed.

The focus should be on the actual demands of the business rather than personal preferences or previous experiences. It’s crucial to determine and document the needs of each functional group participating in the business process, and to obtain their explicit agreement that this document fully and accurately satisfies those demands.

The true capabilities of both systems can be evaluated through research and vendor demos. With a clear understanding of the capabilities of each system, companies can weigh the pros and cons of various approaches.

It is critically important that all the individuals involved strive to be objective and reach consensus across all functional groups. So, it completely depends on the need of businesses that they want to integrate the system or want to use it as a standalone.

If you still have any questions about it, we would be pleased to help. Contact us by sending an email at sales@tecwrk.com  with any questions or requests for a demo.

What is Non-Conformance Software?

Chirag Panjwani on February 16, 2023

What is non conformance management system

What if a food processing plant finds that the packaging of one of its products was contaminated with bacteria during production? Or, the pharma company finds that the manufactured drug batches have the wrong dosage prescribed.

In situation like these, the possible consequences that might come across the manufacturers will be – re-work on the product, scrapping out the wrong ones, time & resource wastage and many a times wrong word of mouth for the brands which could also lead to unsatisfied customers and legal penalties.

Long story short, inability to determine non-conformance is the whole-sole reason manufacturers face situations like these. Keep on reading the blog to explore what it is and how manufacturers can prevent themselves from sliding into situations like these.

Table of Contents:

  • What is Non-Conformance?
  • What consequences does non-conformance have?
  • Non-conformance management as per ISO 9001 standard
  • Tips for mitigating non-conformance
  • How to tackle Non-Conformance?

What is Non-Conformance?

Non-conformance is an indication that a service, process, product, or even the system has went wrong because it didn’t meet a specified set of requirements. A non-conformance indicates that a company’s standard operating procedures perhaps need to be modified or updated in some ways, or both. These deviations can be identified by conducting internal and external audits, analyzing customer complaints, material inspection or routine testing.

After that, a non-conformance report is created. A Non-Conformance Report provides structured documentation of the specifics of a Non-Conformance found. As a result, entities, initiatives, or individuals that fall short of the required standards in terms of quality and safety may be held liable.

This report’s objective is to record the specifics of a departure from expectations. This report assists management in providing a clear and logical definition of the issue so that appropriate steps can be taken to accomplish the desired improvements.

A non-conformance management software ensures that each non-conformance is accurately recorded and addressed with. It helps businesses in upholding quality standards and fostering growth. The module can function independently or in conjunction with our other quality control software.

What Are the Different Types of Non-Conformances?

Basically, there are two categories of non-conformance:

  • Minor Non-Conformance

Minor non-conformance arises on a small level and doesn’t affect the whole company. Therefore, this kind of nonconformance has small repercussions and is much simpler to resolve. For example, small fixes in product manuals. This can easily be fixed by updating the relevant documentation.

A minor non-conformance is typically not a big deal and is easy to fix. Minor non-conformances could, however, grow bigger if they are neglected. Businesses should have systems and processes in place for recognizing and resolving non-conformances in order to prevent minor issues from developing into serious ones. Some more examples of non-conformance are:

  • Multiple violations of requirements.
  • Multiple missing/unsigned documents
  • Improper machine calibration
  • Major Non-Conformance

The entire production or workflow of the company is significantly impacted by a major non-conformance. The end product could be significantly degraded by serious non-conformance issues. Things like untested items or making unauthorized, unapproved changes to the production without documenting, monitoring and communicating the impact of changes are examples of serious non-conformance.

A major non-conformance can have a significant negative impact on a company’s or organization’s reputation and brand. These are more challenging, expensive, and time-consuming to fix than a minor non-conformance. Therefore, tools and processes that are effective in identifying and resolving serious non-conformances before they have a negative impact on their operations are essential.

What consequences does non-conformance have?

If non-conformances are not identified and handled on time, they can create chaos and havoc. For example, failing to address a change to all the concerned departments may lead to incorrect functioning of your employees and thus processes going haphazard. The morale of your organization can suffer as a result of persistent personnel actions that violate ISO 9001 criteria.

Additionally, manufacturing goods that don’t meet criteria can invite rework, scraping, even product recalls, legal suits and what all follows this is obvious. But these consequences can be possibly reduced with the help of a Non-Conformance Management Software.

Non-Conformance Management Software

Non-conformance management as per ISO 9001 standard

The management of these events can be connected to any of the current ISO standards, with ISO 9001 being one of the most popular. In order to constantly enhance operations, improve the quality of output, foster efficiency and competitiveness, and increase customer satisfaction, numerous industrial enterprises have embraced the globally recognized ISO 9001:2015 quality management system.

Failure to adhere to the technical specifications of the products (characteristics, materials, operation, etc.) or of the processes results in the majority of non-conformances within an ISO 9001 management system (delays in delivery times, errors in quantities, human failure due to lack of training, inadequate use of equipment, etc.).

ISO 9001 Non conformance examples

Tips for mitigating non-conformance

It is crucial to set up suitable procedures and vital measures intended to stop Non-Conformance before it occurs. To do this, there are a number of actions to followed:

  • Finding the non-conformance

A non-conformance can be found by any organization’s  stakeholder, including customers, internal employees, suppliers, external auditors, and public administration. This must be disclosed as quickly as possible, whether it occurs via internal or external audits, quality controls, or analysis of consumer complaints or claims.

It is crucial to accurately describe the non-conformance during this initial stage of the process and to provide information, such as the proof that the non-conformance occurred, the document outlining what should have been done but wasn’t, the time and individual who discovered the non-conformance, etc.

  • Resolution of the non-conformance

Once the non-conformance has been identified and thoroughly documented, it must be fixed in order to quickly resolve the issues and the reason that caused it. The work is not finished yet; as it might not be a one-time issue and is can spring-up often; thus, it will be important to address the core cause.

  • Detection and investigation of the non-conformance’s root causes

In order to prevent future replication of the non-conformance, this is a crucial step. There are various effective approaches, such as the problem analysis and resolution tool, for identifying and treating the root cause (there may be one or more than one).

  •  Planning and implementing corrective measures to eliminate the issue

Once the underlying reason of the non-conformance is identified, businesses can take one or more corrective measures to mitigate it, take charge of implementing those measures and decide a timeline for doing so.

  • Verification of the corrective action

The effectiveness of the corrective activities put in place will be determined in this final stage, which is one of the most crucial ones. Check that the deviation no longer occurs as soon as a circumstance identical to the one that caused the non-conformance surfaces.

Remember to solve the problem until you can confirm with absolute certainty that the remedial measure is working.

How to tackle Non-Conformance?

Implementing a Non-Conformance Software or a QMS system integrated with NC module can help you track non-conformances, identify the core issues and speed up the process of implementing the corrective actions in the business operations.

With QualityPro NC/CAPA modules, businesses can obtain real-time data to detect non-conformances at the earliest and minimize their potential impact. In addition, they can have detailed information and tools for root cause analysis of the non-conformance and take corrective and preventive solution to eradicate it and never let the issue occur again.

With this solution, companies increase the agility with which they make decisions and execute corrective actions; experience improved competitiveness and customer service levels; reduce non-quality costs, and comply with the company’s continuous improvement strategy.

Want to make Non-Conformance Management easier, faster, and more structured?
Deploy QualityPro now!! For more details, visit https://www.bmqualitymaster.com/contact-us/ or mail at: contact@bmqualitymaster.com

Essential Elements of Food Quality Management System

Chirag Panjwani on January 30, 2023

Food Quality Management System

The globalization has made the manufacturing market more competitive, by offering new opportunities to businesses old and new. This should not be considered as a threat to the survival of existing manufacturers; in fact, it is a challenge that they should take up. Because this challenge, actually poses an opportunity to gain customer loyalty through the enhanced products and improved services offered in the quest to stand up to the challenge.

By enhanced products we mean ones—that suitably cater to the specific needs and concerns of the customers. Also, when it comes to competitiveness, one obvious question that arises is- “With the rising competition bar, what makes the top manufacturers stand out from the league?”

The answer to this question is “quality of their own products & services”. By maximizing suitability and quality of their products for the consumer usage, manufacturers succeed in excelling in their field— and thus in building a sustainable brand image.

Therefore, to become a successful manufacturer, robust quality control, is of utmost importance. For which, manufacturers need to opt a feature-rich food quality management software. But if you are a tenderfoot, then before implementing a food quality software, knowing the concept of quality and food quality management system is essential.

This blog takes you to a knowledge-intended journey of exploring the term “quality” and the essential elements of a Food QMS.

The Quality Concept-

“Quality is a comprehensive term that includes two meanings: product characteristics that lead to customer satisfaction and the absence of failures. Still, this does not defines “Quality” as a whole. The customer needs are not only related to these two intrinsic characteristics of the product, but also to its availability in the market, it’s appropriate pricing and suitable packaging. These specifications altogether ensure that the customer will buy a safe product standing at par with what is mentioned on the label, without having any health threats.

For these objectives to be achieved, it is necessary to have an efficient food quality management system in place that ensures operational excellence at each level of the organization. Talking of an ideal food quality management software, it must have the following capabilities.

Essential elements of food QMS software

Quality Control- To ensure safety and quality of the food for consumers, adhering to quality requirements becomes a mandate for the food manufacturers. With the absence of quality control procedures, the contaminated foods can easily make way to the markets. In avoiding such situations, the Quality Control module of a Food Quality Software plays a key role. Because it allows manufacturers to create and apply quality tests on the products, at all important junctures of the food supply chain-, that too with set target values.

This ensures quality throughout the product lifecycle: i.e., when materials enter the facility, when they are put ahead for production, and when they are being shipped to the customers. Also, based on the test results of pass/fail, manufacturers get the convenience of accepting and rejecting products accordingly.

Standard Operating Procedures (SOPs) – Food manufacturing refers to the process of turning fresh ingredients into consumable food products. This includes the process of high-volume mixing of multiple ingredients that too in a set order, to manufacture finished goods. These finished goods must have uniform consistency. Even a small deviation in the procedure, could lead to fluctuations in the product quality of the finished goods.

Therefore, documenting processes in the form of Standard Operating Procedures (SOPs) helps organizations ensure error-free and consistent processes throughout the supply chain. This is the reason why “Advanced SOP feature turns out to be one of the prominent features that should not be given away with.

Non-Conformance (NC) & Corrective Action Preventive Action (CAPA)- Non-conformance reports that there is something wrong with the process or product due to which the outcome fails to match the required product specifications. In situations like this, the NC/CAPA functionality of an efficient QMS software comes to the rescue. It helps in successfully dealing with every type of non-conformity that could occur such as:

  • Product non-conformity- Which relates to product issues identified during quality management or by customer complaints.
  • Process non-conformity- Which relates to downtime, machine problems, operational inconsistency, etc.
  • System non-conformity- Which is identified by internal audit system
  • Material non-conformity- Which occurs due to expired materials, ingredients

The NC functionality finds the root cause of the occurred non-conformity, wile the CAPA suggests  the required corrective needed to be applied, and prevents its recurrence, comes out as an un-negotiable part of the food QMS software.

Compliance Management- Throughout the supply chain, adherence to set safety laws imposed by the regulatory bodies ensures that the food item is not unsafe, misbranded, or low-graded for the human consumption.

For that reason, this feature of a food quality software is of paramount importance, that helps manufacturers meet local, regional, national, and international regulatory requirements such as Global Food Safety Initiative (GFSI), International Organization for Standardization (ISO), Hazard Analysis and Critical Control Point (HACCP), Good Manufacturing Practices (GMP), Food and Drug Administration (FDA), etc.

Document Management- This capability is essential to control the pile of documents a food business needs to manage for several reasons. This includes formula/recipe details, SOPs, compliance policies, training manuals, recall procedures, labels, etc. These crucial records must be accessible when required, and hence needs to be systematically managed.

But manual management of these documents could lead to maximized manpower requirement & minimized productivity. That’s the reason the document management feature can’t be ignored in the list of essential elements of a food Quality Management system. It automates the task of creating, storing, managing, and retrieving the documents when required— and becomes a significant contributor in enhancing the organizational productivity.

Risk Management- It is the act of setting up prevention strategies to avert potential issues from occurring. Actually, the risk management feature efficiently identifies the potential areas that are vulnerable to business helping organizations carry out necessary actions in response. Though there could be numerous areas of risks in a food manufacturing business, but, the prominent ones out of all are:

  • Supply chain risks- Threats from the quality of materials arriving at the facility
  • Cyber risks- Data corruption, data loss, data manipulation  
  • Natural Hazards- Equipment failure, earthquake, Fire outbreak, etc.

A risk management system can help you manage, track and mitigate these risks and that’s the reason why a proper risk management approach is a must-have feature for a robust food quality software and should not be overlooked by the manufacturers.

Final Thoughts-

Food manufacturing involves processing of highly sensitive and perishable items, which makes it more challenging for the manufacturers of that industry to sustain. Hence, right from the purchasing of raw materials to delivery of finished goods, everything needs to be not just streamlined and organized, but inspected too.

For this, other than a good QMS software like Quality Master, no other strategy would deliver better results. If you are also looking to inject a culture of quality into your business, then get in touch with our team of experts today.

What is the Difference between a QMS, EQMS, and an EDMS?

Chirag Panjwani on January 18, 2023

Quality management system

With Quality getting paramount importance everywhere, process manufacturing is no different. Terms like Quality Management System (QMS), Electronic Quality Management System (EQMS), and electronic Document Management System (EDMS) are gaining traction in board rooms, business meetings and on Google Search too. If you have been a part of such discussions, or have overheard or are wishing to know what these terms actually mean and function, then you are at the right place This blog elaborates their meanings, purpose and the distinguishing characteristics of them all for a better understanding. Continue reading-

What is a QMS?

A quality management system (QMS) is a formalized system that documents/describes the workflows, procedures, and responsibilities for achieving a company’s quality policies and objectives, the international standard specifying requirements for quality management systems is ISO 9001:2015 and it is one of the most widely used and prominent approach to quality management systems.

A QMS manages and coordinates an organization’s actions in order to conform to consumer and regulatory standards.

Also read: Different Types of Quality Management Systems

Who needs QMS Software?

In industries such as aviation, automotive, pharmaceuticals, food, and medical devices, where ensuring quality and safety is critical, the implementation of robust quality management systems (QMS) holds paramount importance.

For companies operating in these sectors, compliance with specific standards and regulations governing quality management is mandatory to legally sell their products.

Government agencies require these industries to adhere to stringent quality management system standards to ensure adherence to safety protocols and regulatory requirements.

Traditional Paper-based QMS Software –

Managing documents through traditional paper-based methods has become outdated. The process demands considerable effort, time, and resources to keep data updated, often requiring workers to meticulously handle data entry tasks. Yet, despite their best efforts, there’s always a chance of missing something or making errors.

Manual file management is integral to various operations such as onboarding, record-keeping, investigations, and both internal and external audits. Even minor errors in the data can lead to significant miscalculations. Hence, there’s an urgent need to transition to an electronic data storage system.

This transition aims to minimize errors, boost productivity, and allocate resources towards tasks that significantly contribute to the overall efficiency.

What is eQMS Software?

A modernized approach to quality management systems is the electronic quality management system (eQMS). It revolutionizes the management and documentation of organizational-wide business processes like product development, quality assurance, and compliance, eliminating the need for manual paperwork.

The cloud-based version of eQMS operates on cloud servers and is accessible only by authorized users from any location and at any time. Essentially, eQMS encompasses all the components present in QMS solutions but with the added advantage of centralized accessibility and enhanced security.

eQMS has demonstrated superior performance over traditional QMS software due to the ease, efficiency, and flexibility it provides compared to conventional quality management systems.

Difference between QMS system and eQMS system

What is EDMS Software?

An electronic document management system, or EDMS system, is a digital platform designed to manage various types of documents, whether they’re related to the Quality Management System, product development, HR, legal, or other categories. This system is versatile and can store different file formats like Microsoft Word, PDFs, 3D drawings, and more.

Traditionally, employees spent a considerable amount of time searching for and organizing documents manually, impacting their productivity in core tasks.

The transition from paper-based documentation to Electronic Document Management Systems has revolutionized accessibility, making documents available on smartphones or tablets.

EDMS solution isn’t limited to text documents; it accommodates various file types like images, videos, and audio files. It offers a unified view of all documents and incorporates features for printing, scanning, and storage.

A key advantage of an efficient EDMS software is its ability to automate document-related workflows, integrating seamlessly with other software such as ERP, QMS, or CRM systems. This connectivity streamlines processes and enhances overall operational efficiency.

This is how EDMS helps in building Quality Management –

To create a digital Quality management system, you can migrate all of your current quality documentation onto an EDMS, which is a cloud-based platform. It can benefit you with –

  1. Controlled document lifecycle: An EDMS streamlines document classification, organization, and archiving from creation to archival, enhancing searchability and indexing accuracy.
  2. Tailored workflows: Tailored for quality specialists, an EDMS offers pre-defined processes while allowing customization to suit unique operations, unlike an eQMS.
  3. Change and design control: Flexible adjustments to quality processes with comprehensive record-keeping for all modifications.
  4. Document review alerts: Ensures timely completion of review and approval cycles, maintaining the flow of documents within the system.
  5. Version control and audit trails: Automatically generates audit trails, displaying version histories, changes, and approvals for document transparency.
  6. Integration with e-signatures: Compliance-driven e-signature functionality (e.g., FDA 21 CFR part 11) to authorize documentations as per regulations.
  7. Enhanced SOPs and compliance records: Robust search and navigation features in an EDMS facilitate compliance inquiries, offering flexibility in SOP management while serving as a unified data source.

Difference between QMS, EQMS, and EDMS

While QMS solutions aim to meet quality procedures, they have grown obsolete and traditional; in contrast, eQMS has all the features built in accordance with technological advancements and rapidly shifting compliance standards. The line of distinction between these two names is extremely thin.

However, we may conclude that eQMS is a more contemporary and effective version of QMS solutions. The eQMS seeks to automate quality management operations, maintain compliance, monitor product quality, identify non-conformance, and conduct audit activities while reducing costs & time to market by keeping all of the important company information in a centralized repository.

When it comes to EDMS, it differs slightly from eQMS and QMS. The area that this solution covers completely is the documentation and its lifecycle from creation to storage, however, EDMS is also a part of handling quality and eQMS.

Difference between QMS, EQMS and EDMS

QMS, EQMS, or EDMS, which one do you need?

Choosing the right solutions out of these three depends on the type of need your business operations have. The choice becomes clear only when you know what your business requirements are, what your strategy is, and which solution fits the best within your business ecosystem.

Venn diagram of QMS, EQMS and EDMS Systems

You can prefer an eQMS system as it is a complete solution serving the needs of a QMS and an EDMS. It outdoes the traditional paper-based quality management systems in ways uncountable and is quickly becoming the new standard for quality management across businesses operating in various industries and of different sizes.

If you’re also looking for an eQMS that can take your quality management process to the next level and instills a culture of Quality, QualityPro is the right solution for you. Contact our experts for details.