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Why Automated Audit Management System is Important?

Chirag Panjwani on October 11, 2022

Importance of audit management system
  • Overview
  • What is an audit? Why is it necessary?
  • Importance of automated audit management system
  • Conclusion

Overview

Before starting a blog about audit management, it is important to establish that the purpose of an audit is not to assign blame, but to find a solution. Many business owners and management personnel view audits as a necessary evil, a box to be ticked to satisfy compliance. However, in reality, an audit can add real value to your company. It can help you spot weaknesses in your infrastructure, expose non-conforming behavior and refine your business processes.

An audit ensures that all the steps of a manufacturing operation are being performed as intended. Manufacturing process audits should verify that procedures are properly followed, problems are quickly corrected, consistency of process is maintained, and there is continuous improvement and corrective action as needed. Companies can outperform their competition with the ability to take quick action on quality data gained from these audits and modify customer outcomes immediately.

Historically, the audit process was conducted manually with paper-based checklists. However, manual audits are no longer suitable in today’s digital age. Technology-enabled tools have taken over the responsibility of managing audit activities to ensure consistent quality and compliance. Regulated companies are increasingly using automated audit management systems to maximize effectiveness while managing costs and streamlining their audit process without sacrificing flexibility.

What is an audit? Why is it necessary?

An audit is the objective analysis and examination of a particular business operation to evaluate its conformity with the expected standards. Audits can have different purposes. A financial audit conducted to check the accuracy of the company’s financial records. Compliance audits are designed to ensure that the company is obeying the latest ISO 9001 standards. A quality audit checks for the application of predefined quality standards. These and many such audits can either be internal or external.

Types of audits

The procedure will depend on the type of audit being performed and the standards governing the auditor’s work. Audits are necessary as they can help the manufacturer pinpoint areas that need improvement. They offer a reliable assessment of the manufacturer’s capability and facilities and provide an overview of the company’s processes, operations, and workflows. Moreover, audits are valuable tools used to uphold employee safety, evaluate operational efficacy and uncover non-conformance issues.

Audit management system process

Importance of automated audit management systems

Technology aids in drastically reducing the cost of audits. Centralized operations and simplified reporting allow for accurate, actionable insights, so that auditors don’t have to waste time tracking down information in spreadsheets. An effective audit management system simplifies the day-to-day work by standardizing methods and automating repetitive tasks, hence boosting the performance and effectiveness of the entire auditing process.

An audit management software can plan, schedule, perform, report and close-out the process with automated workflows. It helps companies improve business performance by reducing risk and managing compliance. It also provides end-to-end functionality for the entirety of the audit life cycle which includes audit planning, checklists, data collection, audit reports and CAPA recommendations.

The key benefits of an automated audit management system are listed below:

Benefits of audit management system
  • Reducing Duplication – Conducting an on-site audit coupled with filling piles of duplicate data can be frustrating for the auditor. Using an audit management software, the auditor can gather evidence and answer questionnaires on the spot. With anytime & anywhere access, this software allows you to download the audit and attach relevant data as it is gathered. As a result, there is no duplication of effort, saving precious company hours or even days for every audit. The customizable report feature makes it easy to display data visually.
  • Data Accuracy – Writing notes or completing a paper-based checklist can be error-prone and bias driven. With an audit management system, auditors can capture real-time evidence and attach any type of common file including videos, photos and sound recordings. They can attach evidence of non-conformances that can be viewed by everyone in the same way, leaving no room for misinterpretation. The ability to collect data from different sources and applications reduces operational oversights and ensures a smarter decision-making system.
  • Pre-defined audit checklists – With an audit management system, companies can get pre-defined audit checklists. Audit managers can configure and add new fields in the checklist to suit business requirements. Standardization of processes and documents ensure the implementation of industry best practices. The checklist includes gathering preliminary information to scope the audit, determining the key business risks, identifying areas for more audit attention and informing managers about data needs.
  • Greater visibility – Audit management software has powerful reporting capabilities to provide greater visibility into critical audit results like findings, best practices & auditor recommendations. It also facilitates quick generation of detailed audit reports and distribute them to all the involved parties. Auditors can produce different types of reports for different types of audits, each providing you valuable insights. A unified dashboard of audit reports and results helps you make informed business decisions on the required improvements and changes.
  • Accurate compliance – Working from paper trails makes compliance difficult to prove – one missing file and you risk non-conformances or failing the audit completely. Audit management systems allow you to easily plan and schedule regular internal audits, with automated workflows triggered when a finding is raised. This makes it very easy to demonstrate commitment to regulations and other quality standards, delivering a full and comprehensive audit trail for anyone investigating your compliance.

Audit management solutions help enterprises align their critical processes with business quality objectives while mitigating operational challenges. They empower organizations by giving the more control and confidence in addressing compliance, quality, and operational risks efficiently through regular audits. One such software, QualityPro prepares you to succeed with a next-generation approach to identify and eliminate inconsistencies throughout the quality system, products, and processes. If you want to automate your quality management activities with QualityPro, click here.

Four Key Ways QMS Software Supports Change Management

Chirag Panjwani on September 27, 2022

Change management in QMS system
  • Overview
  • What Is Change Management?
  • Process of Change Management
  • How QMS supports Change Management
  • Conclusion

Overview

Heightened global competition has motivated manufacturing companies to constantly innovate their product offerings. To keep pace with this accelerated pace of change, companies need to develop a dynamic work culture and environment. Change does not come naturally to people or organizations and without proper management, a change can cost precious time and money. It is also vital to measure the scale, magnitude, duration and strategic importance of the change.

Organizations would do well to address and balance the multiple aspects of change like people, process, technology etc. Creating a change management plan can help with a smoother transition from the old to the new. While proactively combating resistance to change, companies need to set clear goals for the changes and monitor the results vigorously. By creating effective strategies to implement change, manufacturing organizations can ease out the process for their people.

What is Change Management?

Change management is the process of planning, implementing and validating changes in the organization. It refers to the organization’s ability to handle modifications like implementing new technology, adjusting existing processes and shifting organizational hierarchy. Change managers need to set key performance indicators (KPIs) and relevant metrics to measure the effects of the change. In the present scenario of rapid product changes, the co-ordination of design centers, suppliers, testing labs, manufacturing facilities, offshore plants and the marketing department becomes very critical in change management.

Change can be a consequence of innovation, customer complaints, material returns, non-conformances and similar occurrences. Upon implementing a QMS (Quality Management System) in the organization, managers can standardize their response to every new development with automation. It can even shorten the change process cycle time and reduce the impact of change on everyday operations. We will elaborate about the benefits of QMS for change management further in the blog, but let us first discuss the process of change management.

Process of Change Management

Businesses must constantly evolve and adapt to meet a variety of challenges like changes in technology, rise of new competitors, a shift in laws/regulations or any underlying economic trends. Change processes have a set of starting conditions and a functional endpoint. Change initiatives may be different from each other, but they typically follow a similar process. To effectively manage change, managers must thoroughly understand the steps involved. The key steps in the change management process are listed below:

Process of change management
  • Prepare – The organization needs to be prepared for change, both logistically and culturally. All employees should recognize and understand the purpose of change.
  • Plan – The definitions of KPIs and strategic goals should be pre-defined. The scope of the project and the hierarchy of reporting must be laid out beforehand.
  • Implement – The steps laid out by the management must be diligently followed. Employees need to anticipate roadblocks and prevent, remove, or mitigate them once identified.
  • Embed – The changes inculcated by the process should become part of the company culture. Change managers need to ensure that the process doesn’t revert back to the old ways.
  • Review – conducting analysis and review to make sure that the change was successfully implemented. It can offer valuable insights that can be leveraged in future change efforts.
How QMS system supports change management

How QMS Supports Change Management

Paper-based quality processes can hinder innovation-centric changes and even cause non-compliance in a regulated industry. By implementing a QMS, the change is managed in a workflow-based system and quality is benchmarked at every step. The “Make it once, change if often” philosophy of the present product developers can benefit from the dynamic work environment created with the help of a QMS. Let’s discuss the four key ways QMS software supports change management:

  • Change Process Automation – Automation of the change management process results in increased control over the variables. A QMS provides the right tools for the organization to exercise control over the tasks, processes and documents of change. Everything including routing, follow-up and approval can automated through a QMS.  Managers can effectively define process ownership and user control for increased accountability. Automatic escalation can speed up departmental collaboration and new approvals can automatically supersede any old versions.
  • Transparent Change History – A time-stamped and secure audit trail enables the stakeholders/auditors/regulators to view the entire edit history of documents in a chronological order. Complete record of people who request, approve and validate the changes is also saved in the system to allow for complete transparency. QMS can also present key metrics relating to open change tasks on a unified dashboard and generate reports in an efficient manner to identify bottlenecks and other issues.
  • Closed-loop Change Management – Vigilance is not enough for compliance. Organizations need a QMS to follow a proactive approach by connecting all quality processes. CAPA issues and deviations will seamlessly trigger change management and training through the QMS system. If a CAPA issue requires new training, the QMS will facilitate task completion with automatic notification and follow up. The system unites different processes and individual users into a holistic compliance effort so that every issue is identified and resolved.
  • Shorter Change Cycle Time – Efficient change management and change control leads to timely regulatory submissions and faster time to market. Once a change control request gets approved, a QMS automatically generates and routes all the related documents (Ex. SOP, change order) to the concerned departments. Gone are the days, when this process was done via long trails of e-mail or through in-person meetings. Every step of implementation and post-implementation assessment are automated with QMS to close the loop quickly and effectively.

QMS can help companies achieve change management and change control according to cGMP regulations and ensure product safety and quality. While every regulated company wants to comply with requirements, they need to leverage the right QMS software to attain and maintain compliance despite the constant change in their operations. QualityPro is a next-gen QMS software that supports change management along with all the other quality management requirements of a manufacturing company. If you wish to request a demo, please click here.

What is Quality Risk Management Software?

Chirag Panjwani on September 27, 2022

What is risk management system

Managing a business involves a variety of risks, including natural calamities- something that’s completely out of your control. These risks have an enormous potential to make your business face downfall or distress. Even the tiniest risk has the capability to put your entire business process at stake.

And, what’s more? They can be expensive and time-consuming to fix. Regardless of company size, CEOs, VPs, or risk management officers should foresee the risks and have a plan to curtail these risks and address them before they hamper their business.

In this blog, we’ll define risk management, go through all the key points, and explain how our quality risk management software can help you manage risks. With all this info, you’ll be able to plan your risk management strategy and needs better.

Contents:

  • Overview
  • What is risk management?
  • Risk management principles
  • Risk management process
  • Why is risk management crucial for your company?
  • QualityPro: Tackles your risk to let you focus on your business processes
  • Summing Up

Overview

Ideally, I would say it is impossible to eliminate all the risks but, it is possible to think about all the potential risk factors that your business could experience and stay prepared to handle them. And this is doable with automated risk management software. An effective risk management software focuses on the connection between risks and their significant harmful impacts that can stop organizations from fulfilling their strategic goals.

Let us first know what risk management is and what its causes are –

What is risk management?

The process of identifying, assessing, and controlling threats to an organization’s assets and earnings is known as risk management.

Risks originate from a range of sources and can be both internal and external. Internal risks can be caused due to your employees, vendors, leadership decisions, etc. whereas external risks can be caused by a number of things such as financial uncertainty, legal responsibilities, technological problems, strategic management blunders, accidents, and natural calamities.

Talking about the situation that occurred say two years before,

When COVID-19 entered the market, businesses faced a significant threat to their operations. Prior to the pandemic, nobody ever imagined or was prepared to deal with the level of impact it had on practically everything, including businesses.  Numerous businesses collapsed, many people lost their jobs, and factories were shut down, all of which resulted in huge losses. Now that the COVID-19 effects are stabilized, CEOs and Directors of various companies are taking a fresh start to look at their risk management programs. They are reconsidering their risk exposure and examining risk-mechanism processes.

Companies are considering the competitive advantages of a proactive strategy and substituting it for their existing strategies, reducing the use of traditional techniques like guarding against past risks, changing risk management only after a risk has caused harm, etc. Business interest in achieving sustainability, resilience, and corporate agility has increased because of this.

Before moving further, it is now important to look at the principle of risk management.

Risk management principles

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) states that there are two main principles of quality risk management:

  • A better risk evaluation should be based on facts and research from scientific knowledge and should ultimately aim to protect customers.

A quality management procedure should be proportional to risk level- higher the level of risk, stronger the plan. The time required, and formal documentation requirements should all be in line with the degree of risk.

Risk management process

The five steps of ISO’s risk management approach are as follows:

Step: 1 Identify the risks:

List out all the risks that your company might experience while operating. Generally, this process is performed routinely. Start a risk assessment by looking at the elements in your business and surroundings that could be risky, such as regulatory, legal, environmental, market, and other hazards.

 You should be aware of potential threats to your company, such as technical hazards, single point of failure (SPOF) dangers, and natural calamities.

Step: 2 Analyze the risks

After identifying the risks, conduct a risk analysis. Some risks can bring your business to a standstill, while some will only be minor inconveniences. To analyze each threat and determine its potential disruption, ask: “How probable are these risks to occur?” And, if it occurs, then what are the consequences?

You can then establish a link between the risks and varied factors within your organization. This will help you comprehend how many business operations the risk influences. The risk increases as the number of functions increases.

Step 3: Evaluate and prioritize every risk

Rank and order each risk according to its intensity. This helps the risk management team to view and understand the complete risk exposure of your firm. For instance, threats that might only cause little inconvenience should be given less importance than those that could result in catastrophic losses.

Determine your risk appetite and tolerance by creating a risk profile. Some businesses feel confident taking a lot of chances, while others desire to take no risks at all.

Step: 4 Treat your risks

Create a risk management system to mitigate each risk. You and your team should start by addressing the risk with the highest priority in order to prevent it from jeopardizing your organization. Contacting the appropriate experts in each field where the risk exists is a clever way to begin.

Step: 5 Monitor your risks

Determine whether your risk mitigation activities are sufficient or whether you need to make any changes by routinely monitoring, tracking, and reviewing your performance. If the risk management approach put in place is not workable, your team will have to start again with a fresh procedure.

To solve issues, avoid acting on impulse and getting into “firefighting mode”. Instead, a cool, clear perspective will help you limit the damage caused by project hazards and seize opportunities.

Why is risk management crucial for your company?

If you are still not convinced, consider the repercussions of delaying the implementation of a competent risk control strategy until you know how things play out for your company’s bottom line. The picture below mentioned in your business that might make you think again about establishing a risk management system, if still not convinced-

  • Deficiency or Limited Growth

A risk management system can help and facilitate the expansion of your business. There is still a probability that some threats may develop despite your best efforts, no doubt. However, after identifying, evaluating, and controlling risk, your odds of success will increase, enabling more confident decision-making.

  • Lawsuits

Companies that break laws and regulations have the risk of being sued by the government, employees, customers, rival companies, or other parties. If you find yourself in one of these circumstances, your company may have to spend a lot of money on legal bills, settlement costs, or even both. However, adopting a risk management system can limit or even dilute chances of such situations.

  • Large Losses

Additionally, inefficient risk management has a big monetary impact. You stand to lose a lot if you do not have one. This could even include lower market share just because you weren’t able to anticipate changes in the market environment. You risk pecuniary loss if you don’t plan for the risks of growing your company. If you’re not prepared to manage issues, your company’s reputation could also be permanently harmed.

Discover the many advantages of integrating Risk Management Software into your company:

Speaking directly, if not adopting a quality risk management system brings about above-mentioned challenges, implementing one-

QualityPro: Tackles your risk to let you focus on your business processes

QualityPro gives you a thorough understanding of your business’s risk landscape. This covers all product lines, company divisions, processes, quality control, document management, and much more. You can easily identify and mitigate long-term system, process, and product risks with the help of this risk management software’s tracking and proactive management. It is an innovative tool that helps in mitigating and avoiding risks as well as stealth process flaws that are in line with their impact and likelihood of occurring.

This Risk Management System creates a secure and simple-to-understand platform with modern capabilities, allowing you to keep a rigorous eye on risk updates.

The list of features that follows clearly illustrates why QualityPro Risk Management System is the top choice in the industry:

Features of risk management software

Summing Up:

The pandemic is a great example of a risk issue that emphasizes on taking a holistic, long-term strategic view and action on the various kinds of risks that could hurt you as a company. It’s time for businesses to think about controlling threats and utilizing them to their advantage in order to minimize any bad effects on the company.

QualityPro enables you to evaluate risks and identify the broad effects of each risk more quickly by providing risk heat maps, dashboards, and reports. Schedule a demo to see how easy it is to know what risks to mitigate, how to mitigate them, track workflows, collect and store documents, and much more!

How Does QMS Software Work for the Chemical and Agrochemical Industry?

Chirag Panjwani on August 25, 2022

QMS software for chemical and agrochemical industry

If you have landed up on this blog page, probably you are a chemical or agrochemical industry manufacturer looking for a tool that can help you with managing the quality of your products or services. As this industry has a lot of things to manage from quality of materials to packaging, environmental incidents to toxic dispersions, etc., you need a comprehensive quality management software for chemical industry that can align all the organizational processes, activities, and systems with compliance standards to ensure minimum environmental, health, and safety hazards involved.

Chemical or agrochemical manufacturing has under its umbrella- fuels, pesticides, paints and solvents, cleaning chemicals, disinfectants, etc., industries and managing the quality of these products while keeping safety first is not at all an easy task.

This blog will include:

  • Overview
  • Challenges chemical and agrochemical industry faces
  • Enter Next Gen eQMS for chemical & agrochemical industry
  • QualityPro’s effectiveness in managing chemical and agrochemical industry
  • Concluding Thoughts

Overview

To begin with, QMS for chemical industry is an advanced quality management tool that helps chemical and agrochemical manufacturers get better visibility and traceability into their quality processes.

This means they can manage entirely each, and every component of their processes related to quality seamlessly and effortlessly. Let’s now know the challenges this industry experiences and how QMS helps.

Challenges chemical and agrochemical industry faces –

On the path to achieving quality management, chemical and agrochemical manufacturers encounter various obstacles, such as new compliance requirements, patent registrations, re-registrations, verifying third-party suppliers, etc.

They are tasked with managing the demands of a supply chain that is becoming more intricate and global. They struggle to manage compliance with regulations like OSHA, EPA, ISO, etc. In addition to monitoring product quality and enhancing supplier-vendor relationships, they aim to launch products more quickly. Moreover, they must ensure that none of the dangerous chemical substances endanger the safety or health of their workers. These difficulties multiply in complexity when the production or packaging process is not transparent and traceable.

Therefore, a quality management system for chemical industry can have a significant positive impact on  manufacturing companies of all sizes and types, resulting in greater productivity, lower operating costs, better information flow, and improved performance management.

Enter Next Gen eQMS for chemical & agrochemical industry

A thorough QMS for chemical manufacturing industry incorporates the rest of the business in terms of the legal duties for environmental, health, and safety protection. By following SOPs, getting alerts for all deviations, and following the industry best practices, chemical industry operators can rest assured to get consistent product quality.

A Quality Management Software for chemical industry should be able to provide the following benefits, then only it is recommended the most:

Benefits of QMS software for chemical industry

QualityPro’s effectiveness in managing chemical and agrochemical industry

QualityPro offers chemical businesses with built-in quality methodologies and advanced user workflow to help companies manage and track Quality Management Systems. It elevates organizations into a collaborative and paperless environment for ongoing improvement while lowering the overall administrative costs of maintaining quality at every level, thanks to its integrated modules for quality and compliance management.

QualityPro is available as a stand-alone eQMS solution and can be integrated with BatchMaster ERP products, including BatchMaster ERP for SAP Business One. The modules are fully connected, enabling quick data transfer between them, execution of corrective actions straight from complaints or adverse events, and tracing and tracking of the data from the source to the event and back. This creates and stores an audit trail of the whole event for future use.

Being a cloud-based QMS software, it creates a sole source of truth for products, processes, and quality data, ensuring that each stage of the process is synchronized and compliant. It allows all relevant stakeholders to quickly communicate, store operational processes, and retrieve records in real-time.

This is how the software works effectively for the agricultural and chemical industries:

  • Maintains the audit trail of documents viewed, accessed, and modified by any user
  • Maintains and tracks nonconformity records and suggests preventive actions accordingly
  • Records the corrective measures taken to prevent the recurrence of non-conformance
  • Performs verification and maintains the effectiveness of CAPA or any other vital information related to the CAPA verification process
  • Stores documents in a centralized database for resolving customer complaints
  • Supports change management cycle

Concluding Thoughts

We truly hope that this blog was able to clarify how QMS software for the chemical and agricultural industries works. QualityPro, a comprehensive QMS for chemical industry brings the entire organization in agreement with the regulatory standards for safety, health, and environmental care. By following the industry best practices defined as key quality requirements, chemical industry operators can rest assured to get consistent product quality.

You can reach us at contact@bmqualitymaster.com for a free consultation.

What is Electronic Quality Management System (eQMS Software)?

Chirag Panjwani on July 27, 2022

what is electronic quality management system

Overview

Historically, paper-based and spreadsheet-centric quality systems were used to monitor and analyze quality-related data. Manual data entries and disconnected files made it difficult to track and manage quality-related information. Regarding challenges, while addressing top-quality management objectives for life sciences industry, respondent results were:

Quality management software (eQMS Software)

All thanks to the evolution of integrated IT-based systems like eQMS that made it easier to record and report quality variables across various access points. This blog discusses the definition, functions, benefits, and future of eQMS software with respect to total quality management.   

What is Electronic Quality Management System?

An Electronic Quality Management System (eQMS) is a software solution designed to electronically handle, document, and manage quality-related processes within an organization. Its primary objective is to ensure that products meet required standards, are free from defects, and operate within defined tolerances.

This software encompasses a range of techniques, structures, processes, and resources necessary for efficient Total Quality Management (TQM) practices. By leveraging an eQMS, organizations aim to enhance process efficiency and minimize human error.

One of its key advantages lies in its ability to proactively identify potential quality issues before they manifest. It grants enhanced visibility into Quality Assurance (QA) and Quality Control (QC) processes within a manufacturing organization.

Core functionalities of an eQMS include compliance management, change management, investigation of adverse events, initiating corrective and preventive actions, managing risks, and integrating complaint management into the quality process.

The system operates as a closed-loop, ensuring accountability at every level of the quality management process.

eQMS software can be implemented through various deployment models such as on-premise, cloud-based, or hybrid setups. This flexibility allows organizations to choose based on their data access requirements.

Furthermore, these systems often offer integration capabilities with other business management software such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Product Lifecycle Management (PLM), and Manufacturing Execution Systems (MES) to streamline operations across different departments and processes within the organization.

Difference between QMS and eQMS

The difference between a Quality Management System (QMS) and an Electronic Quality Management System (eQMS) lies primarily in their operational modes, capabilities, and efficiency in managing quality-related processes:

Operational Approach:

  • QMS: Traditionally, QMS may rely on manual processes, spreadsheets, or paper-based documentation to manage quality-related operations. These methods can work independently, potentially leading to discrepancies and various versions of information.
  • eQMS: eQMS integrates all quality management functions into a single, unified software system. It stores and manages all quality-related data in a centralized location, offering a single source of truth and reducing the risk of version discrepancies.

Data Accessibility and Security:

  • QMS: Paper-based or spreadsheet-centric QMS can limit access to updated documents and lack a comprehensive record of changes.
  • eQMS: Ensures access to updated, authorized documents, and maintains an audit trail of all changes. Unauthorized or unsigned documents are flagged, enhancing data security and compliance.

Regulatory Compliance:

  • QMS: Managing regulatory compliance can be challenging with traditional QMS, potentially leading to compliance issues due to manual processes and inadequate documentation.
  • eQMS: Provides convenience and ease in handling regulatory compliance documentation by offering features specifically designed to manage compliance requirements effectively.

Develop a Culture of Quality…

“55% of respondents who don’t own enterprise quality management software (eQMS) say their quality metrics aren’t properly measured.”- LNS Report

The effective utilization of an Enterprise Quality Management Software (eQMS) is pivotal in fostering a pervasive culture of quality within an organization. When every individual within the company embraces a quality-centric approach and resources are aligned to deliver superior products, it reinforces a culture committed to excellence.

Specifically designed to optimize various quality-related aspects in manufacturing, eQMS software ensures streamlined maintenance of factory equipment, meticulous inspection of raw materials and finished goods, and proficient handling of quality audits.

Successful eQMS implementation yields numerous benefits, including heightened product quality, reduced product recalls, minimized wastage, and fewer warranty claims, all contributing to improved operational efficiency.

eQMS systems offer robust data integration capabilities, consolidating quality-related information into a unified database. This integration drives continual improvement across the entire product life cycle.

Additionally, eQMS solutions are conveniently scalable, adapting seamlessly to the growing needs of the manufacturing organization. By eliminating departmental silos and establishing automated alerts for immediate attention to quality issues, eQMS promotes accountability.

Addressing the culture of quality, ISO 9001:2015 serves as the primary regulatory guideline, ensuring the adherence to specified quality standards across the organization.

eQMS software aligns with ISO 9001:2015 requirements, ensuring that processes, individuals, systems, resources, and final products meet the stipulated standards. This guideline outlines key characteristics for a company’s culture, emphasizing quality in business processes, workforce efforts, and the end product.

What are the Features of an Electronic Quality Management System?

Specific facets of total quality management require specific features to be included in the eQMS system. Below listed are the most important functions of eQMS:

Features of Quality Management System
  • Non-Conformance – It is important to identify product issues by testing for quality and eQMS helps the organization identify events of non-conformance in following the SOPs. Valid issues are considered for further actions, while invalid issues are terminated on the spot. eQMS also records all the actions taken to correct the non-conformity.
  • CAPA – When a non-conformance issue is identified and found to be valid, eQMS initiates the process of improvement. It specifies the corrective actions that need to be taken in terms of change in process and the preventive action required to rework/scrap the product, so that the final product quality is maintained up to the standards.
  • Complaint Management – The eQMS software helps manufacturing organizations establish a complaint handling process. The entire complaint management life cycle from documenting the problem, performing root cause analysis, providing timely response to the customer, and triggering internal CAPA is integrated into the eQMS system.
  • Change Management – When a process change is required or a CAPA issue is raised, the eQMS system manages and documents the entire change control process. It helps businesses automate the entire change management process starting from initiating change requests, impact evaluation, actual implementation, and culminating with verification and closure.
  • Training Management – eQMS helps organizations keep their employees updated with the latest certifications on all controlled documents in the organization. It helps manager identify training needs and keeps track of employee performance throughout the process. The eQMS software can also issue certificates on completion of the training modules.
  • Document Management – eQMS manages all the critical documents of the organization from creation to approval & publishing to archival. Along with updating to the latest version of the documents, eQMS also facilitates the removal of obsolete files. It can also create a master list and document map to track document changes.
  • Compliance Management – eQMS can help manufacturers by maintaining a clear list of compliance requirements. It automates the tracking and control of compliance-related activities like documentation, planning, reporting, audit, etc. eQMS also simplifies the reporting of non-compliance events to save the company from legislative action.
  • Risk Management – eQMS takes a very structured approach to identify, assess, control, communicate and review all the quality risks in the organization. With eQMS, organizations can take actions to ensure that any anticipated problems don’t occur and if they do, have a control mechanism to rectify them.
  • Audit Management – eQMS helps organizations conduct internal and external audits to enhance product quality. It can schedule, structure, perform and assess periodic and ad-hoc audits within the specified time frame. The audit management functionality also helps organizations meet industry-specific compliance requirements.

What are the Benefits of Electronic Quality Management Software?

An eQMS can transform the manufacturing organization in terms of men, machines, materials and methods. Below are the major benefits of an eQMS:

  1. Enhanced Effectiveness: Clearly defining and achieving quality objectives set by the organization.
  2. Cultivating a Quality Culture: Instilling a values-based system focused on maintaining high-quality standards across the organization.
  3. Streamlined Data Management: Establishing a centralized database for consistent and accurate data management, ensuring a single source of truth.
  4. Enhanced Accessibility: Enabling access to the system from multiple devices such as laptops, smartphones, and tablets.
  5. Improved Audit Functionality: Setting tolerance levels and creating audit trails to facilitate effective audit processes.
  6. Increased Customer Satisfaction: Adhering to quality policies and implementing streamlined processes directly impacts customer satisfaction.
  7. Enhanced Compliance: Maintaining updated compliance records and automating alerts to ensure adherence to regulations.
  8. Improved Documentation: Defining and documenting critical processes and objectives systematically for better clarity and understanding.

Final thoughts

eQMS focuses on the consistency of the process. It ensures that every time a production cycle is performed, the same information, material, methods, skills & controls are applied in a constant manner. Along with heightened productivity, an electronic qms software helps prevent costly mistakes, enhance product management, improve risk forecasting and establish quality metrics. Therefore, it is important for organizations to implement an eQMS and QualityPro can prove to be a perfect choice.

Get QualityPro today and enjoy the benefits of end-to-end quality management. Feel free to write to us at contact@bmqualitymaster.com, or contact us to know more about it as well as our other products.