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QMS Selection Checklist: Question to Ask Before You Buy an eQMS Software

Questions to ask before buying a QMS Software

Before diving into the topic of what to look for before buying an eQMS, let’s consider a simple analogy. Think about how we plan a vacation. First, we define our requirements—whether it’s a beach holiday, an adventure trek, mountain escape, or exploring a new city. 

Next, we decide the duration of the trip and research potential destinations. Once we shortlist a destination, we compare accommodations, activities, pricing, and traveler reviews. Finally, we book the option that best fits our preferences and budget.

Selecting an eQMS software follows the same logic.

Selecting the right QMS software is important for your organisation. Pick wrong, and your team’s efforts are doubled. They’ll be frustrated. You will weaken your compliance game and will bear the burden of penalties and legal complications.  

Along with this, you might also experience a painful implementation journey and poor results as you bring the system online in your processes. This could also result in giving your competitors an advantage to grow, as you will slow down your time to market, and lack in identifying gaps… 
 
But when you pick right, you unlock a quality approach integrated QMS system that can help you digitise your processes and workflows. Compliance and audit become streamlined. You can identify issues and prevent them from happening in future again. Employees engage, get trained, and a real culture of quality comes to your business life. 
 
If you’re wondering how to make the right choice, we’re here to help. This blog will guide you through the essential checklist to keep in mind when selecting an eQMS software. We hope this information empowers you to make a confident and impactful decision for your business.

QMS Selection Checklist: What to Look for Before Buying an eQMS

A best-fit QMS for you is the one that fits your business needs completely. Here’s a checklist for buying QMS to help you confidently choose the right one before investing:

Quality Management Software Selection Checklist

1. What Should Be on Your QMS Selection Checklist? 

The first checklist point on finding the right QMS software starts with listing out what you need and what your long-term business objectives are. Before evaluating systems, ask yourself what you want to achieve from your business.

Are you aiming to improve compliance, reduce errors, streamline processes, or enhance product quality? Being clear about your goals will help you focus on solutions that truly meet your needs – So, just jot them down.

Also, think about your team and how big your company is. A small system might be fine for a small team, but a growing business will need something that can expand as you do. Knowing your goals upfront makes it much easier to pick up the right system.

2. How Does the eQMS Support Compliance Requirements?

Once you have listed the needs, the second important criteria is to check for compliance. Every industry has its own rules and regulations to follow, be it ISOFDA, or other specific guidelines. And, neglecting them is never an option.

So, your eQMS supports all the regulations you must follow, so compliance becomes a built-in part of your process, not a constant headache.

3. What Functionalities Should You Ask Vendors About? 

Look for essential features such as: 

  • Document Control for creating, managing, and tracking versions. 
  • Risk Management to catch potential problems early. 
  • CAPA to address and prevent recurring issues. 
  • Audit Management for easy scheduling and tracking. 
  • Training & Competency Tracking to keep your workforce up to date. 
  • Dashboards & Reports for quick, actionable insights.

4. How User-Friendly Is the QMS Interface? 

A good QMS should be simple to use, with intuitive navigation and mobile-friendly access so teams can work from anywhere. While picking up a QMS software, this aspect should also be as an important checklist point.

5. Does the QMS Integrate with Your Existing Tools? 

Your manufacturing QMS software should work hand-in-hand with the tools you already use—ERP, CRM, production systems, and more—to keep data consistent and workflows smooth. If it can’t integrate, it will affect your operations and create more problems than it solves.

6. What Questions Should You Ask Before Buying a QMS? 

Vendor evaluation is about more than features — it’s about partnership. When comparing providers, prepare a list of questions to ask before buying QMS, such as:

  • How is data stored, backed up, and secured? 
  • What kind of training and customer support do you offer? 
  • How frequently do you release product updates? 
  • Can you share case studies or success stories? 
  • Does the QMS scale with business growth or multi-site operations? 

The vendor’s answers will reveal their reliability, technical strength, and commitment to long-term success.

7. How Secure Is Your Data in the QMS? 

Next checklist is Data security…Your QMS will hold some of your business’s most sensitive information, so it’s non-negotiable to keep it safe. Look for solid security features like role-based access, detailed audit trails, and strong encryption. These aren’t just tech add-ons—they’re your safeguards against data breaches and compliance headaches.

8. How Do You Balance Cost vs. Value?

Cheapest isn’t always the best, especially for something as critical as quality management. Weigh the total cost—including setup, licensing, training, and ongoing support—against the value it will bring in efficiency, compliance, and long-term growth. A slightly higher price tag might save you far more down the line.

9. Why Is Taking a Demo an Essential Step Before Buying a QMS?

Never commit to a QMS you haven’t taken for a proper test drive. Ask for a live demo, explore every feature, and get your team involved in hands-on testing. Real-world use will quickly reveal whether it’s as good as it looks on paper—and if it’s the right fit for your day-to-day operations.

Final Thoughts

Many companies rush into QMS selection only to regret it later. Pitfalls like focusing solely on the lowest price, skipping end-user input, overlooking compliance, or ignoring integration needs can lead to costly setbacks. Avoid these mistakes to ensure your system delivers long-term value, smooth adoption, and regulatory peace of mind.
 
Choosing a Quality Management Software like QualityPro is like building a strong foundation for your quality culture. With the right system in place, you’ll streamline compliance, improve efficiency, and set your business up for sustainable growth.

The Role of Change Management Software in Automobile Manufacturing

QMS Software for automobile industry

Change is inevitable. Even the Bhagavad Gita (an ancient book) teaches us the same too. It says, nothing in life is permanent except the change itself. To resist it is to resist life. To accept it is to evolve. This lesson is well-suited for the automobile industry. 

The automotive industry is accelerating towards a future defined by innovation. But with every new development or change, complexity increases—raising the risks for manufacturers to meet the highest standards of safety, quality, and compliance. 
 
Here, even a tiny change— like switching to a new brake pad vendor, adjusting engine calibration settings, or modifying the paint curing temperature—can create chaos. One small shift can lead to confusion on the shop floor, delays in production, or issues with compliance or quality, if not handled properly.  

In fact, the research shows that almost 70% of change initiatives fail—often due to poor planning, lack of communication, and ineffective tracking—which can lead to costly errors or product recalls. (Source: https://pubmed.ncbi.nlm.nih.gov

Read this blog to explore why change management is essential, why it cannot be ignored, and why it is essential to have a robust Automotive QMS (Quality Management System) to manage change.

What Is Change Management? And How It Impacts the Automobile Industry?

Change management means handling any updates or changes in a planned and organised way. In the automobile industry, where things like new parts, updated models, or process changes happen often, managing change properly is very important.  

If not handled well, even a small change can cause delays, errors, or quality issues. That’s why auto manufacturers need a clear system to track, review, and approve changes smoothly and safely. 

The Changing Landscape of the Automobile Industry

Be it the launch of new technologies or constantly changing emission norms, the automobile industry is changing more than any other industry. Recent changes in this industry include:   

  • Electric Vehicles (EVs) – The launch of battery-driven EVs has been the biggest change the automotive industry has seen since the days of launch of the Internal Combustion engine. 
  • Autonomous Technology – More and more cars, be it the ICEs or the new EVs, are now coming with AI and sensor-based technologies. 
  • Connected Cars – Most cars today can communicate with other devices, have Alexa and Google built in, and communicate with other cars as well as with the cloud.  
  • Digital Manufacturing – Most auto manufacturers now have smart factories powered by a lot of automation, data, and real-time analytics. 

With more and more changes coming in and regular innovations & ideas pushing manufacturing boundaries, automakers are under a lot of pressure to adapt to changes while maintaining and exceeding the highest levels of quality, compliance, and traceability.

Why Change Management Is Non-Negotiable?

Automobile manufacturing and automobile component manufacturing are not just about assembling parts; there is a whole lot more to it. It is all about achieving precision, ensuring safety, and meeting global compliance standards such as IATF 16949, ISO 9001, ISO 26262, ASPICE, and others that have set a high bar for quality and safety. Managing changes manually or without a change management software for automobile industry can lead to a host of risks, including: 

Manual change tracking process

Regulatory Non-Compliance –

Without a proper change management system in place, manufacturers risk implementing changes that don’t meet regulatory standards. This not only leads to compliance failures but can also result in heavy penalties, legal action, and even production shutdowns. 

Uncontrolled Revisions

When design or process changes are made without a structured system, it often leads to confusion on the shop floor. Unclear instructions, miscommunication, and overlapping revisions can cause production errors, rework, and increased costs. 

Lack of Traceability –

Manufacturers implementing changes manually or without a digital trail struggle to trace who made what change, when, and why. This lack of visibility complicates audits, hinders root-cause analysis, and makes product recalls slow and chaotic. 

Quality and Safety Risks –

Changes that are not properly documented, reviewed, or validated can compromise the quality and safety of the final product. This increases the chances of defects, recalls, and customer dissatisfaction—ultimately putting the brand’s reputation at risk. 

Miscommunication

Automobile manufacturers that do not have a good change management system frequently find themselves doing duplicate work due to the lack of effective communication, having manufacturing delays, inefficient production, and safety concerns in their products.  

In short, poor change management can not only compromise product quality but will also end up harming customer trust, business reputation, and repeat business. Hence, change management in the automotive industry is a must-have.

How to Manage Change in Automotive Manufacturing?

As said, change management with trackability and traceability is extremely essential for any and every automobile manufacturer today. This is where a robust Quality Management System (QMS) like QualityPro plays a critical role. It acts as a centralised, automated, and traceable platform that enables manufacturers to effectively manage and implement changes across the organisation by facilitating:

Change management process in automobile industry
  • Change Initiation and Tracking – Whether it’s updating a brake assembly design, switching to a new alloy for engine parts, or modifying assembly line torque settings, every change can be logged and tracked with full transparency.
    This includes maintaining detailed records of who initiated the change, when it was approved, and its current status—ensuring visibility and accountability at every step.
  • Collaboration Across Departments – From R&D teams in the USA suggesting an ECU firmware upgrade to plant engineers in India implementing it, QualityPro’s shared dashboards and real-time notifications help break silos. Everyone works on the same version of the change record. So, no more scattered spreadsheets or outdated emails. 
     
  • Review and Approval Workflows – Whether it’s a safety-critical part substitution or a  
    supplier-initiated material change, QMS software automates the approval cycle. It routes requests to the right stakeholders, sends alerts, and ensures only authorized personnel review and greenlight changes—minimizing bottlenecks and errors.
  • Compliance & Traceability – All changes, say, adapting to any emission norms or meeting OEM-specific tolerances, are audit-ready. QMS solutions track every revision, from initiation to closure, maintaining a digital trail to ensure compliance with standards like IATF 16949, ISO 9001, and OEM-specific requirements.
  • Post-Change Validation – Before rolling out a new change, let’s say, new seat belt anchoring process or changing a supplier’s raw material spec, QualityPro mandates structured validation. Only when validated, the change is fully deployed, ensuring no compromise on quality or safety. This change is visible to every single authorised person.

How QualityPro Empowers Automobile Manufacturers to Own the Change? 

QualityPro, an Automotive Change Management Software helps automobile manufacturers with: 

Centralised Control over Every Change 

With QualityPro, change is no longer a scattered, paper-based mess. You can: 

  • Initiate and document change requests—define the source, category, and reason for the change. 
  • Plan and implement seamlessly—track execution steps and affected departments in real-time. 
  • Digitise everything—replace error-prone manual tracking with a streamlined, automated system. 
  • Estimate costs and resources—evaluate the financial impact before rolling out a change. 
  • Prepare your people—identify employees needing training and schedule it accordingly. 

Bring Traceability and Accountability to Life 

  • Every detail matters—and QualityPro tracks it all: 
  • Know who changed what, when, and why—with complete version history and change logs. 
  • Establish procedural workflows—control access, assign responsibilities, and enforce approvals. 
  • Manage lifecycle of every change—from request to execution to closure, with full documentation. 
  • Generate and share key metrics—change versions, training logs, source of change, and more, all available at your fingertips. 

Ensure Compliance at Every Step

  • Stay ahead of audits, recalls, and regulatory mandates: 
  • Systematically store and manage all documents—organised, accessible, and always up to date. 
  • Maintain a full audit trail—record every step of the change process to prove compliance. 
  • Validate and approve changes—before they go live, not after issues arise. 
  • Purge outdated versions—ensure only current, approved documents are in use across the organisation.

Key Benefits of Change Management Software for Automobile Manufacturers 

QualityPro by TecWork is a next-gen QMS with powerful built-in change management in the automotive industry. It centralises all change control needs while ensuring compliance, efficiency, and full traceability. 

  • Industry-Specific – Tailored to meet the unique needs of automotive production lines, parts suppliers, and OEMs. 
  • Seamless Change Control – Track and manage Engineering Change Requests (ECRs), supplier changes, and process updates from initiation to closure. 
  • Automated Workflows – Ensure timely approvals and eliminate bottlenecks with rule-based workflows and smart notifications. 
  • Comprehensive Compliance – Aligns with global automotive regulations, offering built-in tools to support compliance documentation and audits. 
  • Enhanced Supply Chain Visibility – Keep suppliers and teams informed through integrated communication and real-time status tracking. 
  • User-Friendly Interface – Intuitive and accessible for all departments, driving faster adoption and better efficiency. 
  • From process upgrades to regulatory shifts—QualityPro ensures change management runs smoothly and effortlessly. 

Concluding Thoughts

As an automobile manufacturer, staying ahead means handling constant upgrades, complex supply chains, and strict audits. A unified QMS like QualityPro with built-in change management can transform how you operate.

But it doesn’t stop there—QualityPro also offers modules like Document Control, CAPA, NC Tracking, Audits, Training, and more to help you maintain top-tier quality, safety, and compliance.

Types of Audits in Quality Management

Types of audit management

Quality audits assesses how well a product, design, process, or system meets specified standards or procedures. The auditors can perform quality audits both within the organization and externally, concentrating on particular processes, products, or systems.

Quality Audits have two Major Components:

  • The quality system audit, which evaluates the overall system’s effectiveness, and
  • The product or service quality audit, which assesses the products or the services offered

If you are a manufacturing company, seeking to improve your audit process and speed, then this blog is a must-read for you.

Looking for smarter audits? Explore our “Audit Management Feature” now.

Table of Content:

Overview:

Quality Audit is like having a check-up for the quality of business aspects/entities. For example, Quality Audit in pharma industry is like a check-up for a pharmaceutical company’s quality system, making sure everything is working as per the norms defined by the industry and regulatory bodies.

This check-up is done by an audit team or an auditor. These people can be from inside the company or from third party. They examine and verify procedures, records, and activities to make sure they meet the required standards.

A quality audit is important for ensuring that a company follows the ISO 9001 quality system standard. It is also important to ensure that the company performs the correct operations to maintain good quality practices.

Definition of Quality Audit

A quality audit is a systematic, independent examination and evaluation of processes, products, or systems within an organization to determine their compliance with established quality standards, regulations, and best practices.

In simple words, quality audits assess if systems, processes, machines, and manpower are working well, and if in case of deviations, root causes are identified and fixed promptly.

Why Quality Audits are Important?

Regular quality audits are essential for companies to assess performance and formally document outcomes. Organizations regularly performing internal audits gain substantial benefits, pivotal for optimizing growth. These audits evaluate company efficacy and provide insights for effective strategy alignment.

The insights gained from quality audits can lead to more revenue and numerous benefits. With proper quality audits conducted, companies can:

  • Improve the quality of the system as well as the quality of the product
  • Assess the cost-effectiveness of quality systems
  • Measure the effectiveness of quality tactics 
  • Increase productivity by making product output more uniform, reducing mistakes, and cutting wastage of resources and manpower
  • Give employees the chance to report inadequacies in the interpretation of basic quality requirements.

In addition, quality audits identify the root causes too, so organizations can quickly take corrective action. Process, product, and system audits should be front and center of any quality management strategy.

Types of Quality Audits

Types of quality audits

The following is a list of commonly performed quality audit types:

Internal Quality System Audit:

Internal Quality System Audit refers to an evaluation conducted within an organization to evaluate and ensure the effectiveness, compliance, and continuous improvement of its internal quality management processes and procedures.

This audit is performed by internal auditors or quality assurance teams to identify areas for enhancement, confirm adherence to established quality standards, and promote overall operational excellence.

The team reviews work instructions to ensure they follow standard procedures and meet quality targets.

Example: The auditors in the company check documents, processes, and employee access to ensure everything is functioning properly. 

Searching for a faster way to manage audits? “Request a Demo” now.

Supplier Audits:

Supplier audits includes a process of evaluation and collaboration aimed at ensuring both quality and accountability. By comprehensively analyzing multiple factors, companies secure the reliability of their suppliers while holding them responsible for any performance challenges.

The real-time transparency offered by these audits allows businesses and suppliers to jointly monitor purchase order activities and actively address any instances of non-conformities and errors.

For instance, the purchasing team can meticulously review suppliers based on key criteria such as lead time, product quality, costeffectiveness, and certifications.

Production Team Audit:

Production Audit involves checking the work done by the production team. Companies often audit them for Operator Acceptance or Certified Operator programs, or when they need to requalify their skills.

Auditors review changes to their processes, training records, and past work to ensure everything is up to the required standards.

For example: Auditors check if the team followed procedures, and met quality criteria during pre-qualification.

Safety Audit:

During a Safety Audit, the team checks the plans and procedures in place that keep company employees safe. They review how an equipment is used and cross-check the organization’s safety steps.

The company must implement structured safety policies to prevent accidents and injuries, creating a safer and healthier environment for employees.

For example, a safety auditor can examine how employees use safety gear while operating machinery. Or, how hazardous materials are stored in a company’s warehouse.

Facilities Audit:

Facilities Audit checks the quality of a company’s assets, like buildings and equipment. The auditors should monitor systems like water tankers, ACs, HVAC (heating, ventilation, and air conditioning), manufacturing equipment, technology, etc.

This type of audit focuses on ways to improve safety and quality outcomes.

Example: During a facilities audit, the team inspects the fire extinguishing system to ensure it is approachable and works efficiently, creating a safer workplace for employees.

Environmental Audit:

Environmental audit helps companies make their workplaces greener and less polluted/toxic. It identifies potential risks and creates a plan to meet safety standards like OSHA, cGMP, etc. The audit team checks to see if employees follow these standards and use proper disposal techniques.

For example, the team inspects if hazardous waste are disposed of properly in the prescribed way and proper documents are maintained for it.

Risk Assessment Audit:

Risk Assessment Audit helps companies identify workplace risks. They categorize each risk and put measures in place to prevent accidents, quality issues, machine failures, natural disasters etc.

For example, during the audit, Auditors may identify that the slippery floors in the manufacturing area pose a risk of falls. To prevent accidents, they install non-slip mats and provide safety training to employees. This way, they reduce the chances of workplace injuries and avoid potential financial losses.

Design Control Audit:

Design Control Audit ensures that manufacturers follow a proper, compliant, and systematic method to produce safe and high-quality products that meet user needs.

The audit team solely reviews the design plan, inputs, and outputs to ensure they meet specific criteria and analyze potential risks before they occur.

For example, in the medical device industry, the audit team can check if the design of a new surgical instrument meets the required safety standards. And, if it effectively fulfills the needs of surgeons during procedures. If not, they can take appropriate actions to address and rectify the issues.

Regulatory Audit:

Regulatory Audit checks if a company follows specific rules and standards set by regulatory agencies. They review quality practices and gather crucial data to find grey areas where the company is not following the rules. 

For example, the auditors can verify if the aircraft manufacturer complies with FAA (Federal Aviation Administration) regulations to ensure the safety and quality of their aircraft.

Method Validation Audit:

Method Validation Audit is done by regulatory authorities like the FDA to check if the testing methods used in manufacturing are standardized, consistent, and well-documented. It ensures that products made for human use are reliable and accurate.

For example, in pharmaceutical manufacturing, a method validation audit can verify the testing procedures used to check the potency and purity of medicines, making sure it is effective in curing the disease for which it is made.

However, managing all these types of audits together can be a cumbersome task. But, with comprehensive audit management software in place, audits can become as simple as ABC.

It effectively manages all types of quality audits while streamlining the entire audit process. From planning to reporting, the software ensures that the audits conducted are effective, consistent, and accurate.

QualityPro: To Manage all your Audit-related Activities

QualityPro is the next-gen QMS software with a feature-rich audit management solution. It can automate audit tasks, provide a central repository for documentation, enhance communication, track progress, and provide indepth insights. 

This audit management software makes audits easier by ensuring they are done consistently, efficiently, and effectively. It automates audit scheduling, generates checklists, stores evidence, creates reports, and tracks corrective actions.

Using this audit management solution, audits occur effortlessly, cover all important areas, keep the proofs safe, share results with management and stakeholders, and implement fixes on time. It simplifies  

Key Features of QualityPro: an Audit Management Software can

  • Manage and submit quality management system audit checklist
  • Define different types of audits and specify whether the audit requires approval or not
  • Define different audit categories, like Departmental Audit, Documents Audit, Financial Audit, Organizational Audit, etc.
  • Define different audit classes like Internal, External, Remote, etc.
  • Manage and store all the points that make up an audit checklist
  • Specify the different requirements that make up an audit checklist
  • Perform follow up audit to ensure that the corrective actions put in place were effective
  • Audit module is connected with CAPA, any NC encountered during Audit can be escalated for root cause analysis and CAPA, and this NC, upon resolution can again be sent for follow up audit ensuring 100% rectification.

Want expert guidance on audit management? “Contact Us” to learn more.

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

QMS Software

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 software (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.

Who needs QMS Software?

In industries such as electronics, automotive, manufacturing, food, fmcg and many more, 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.