Four Key Ways QMS Software Supports Change Management

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


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. QualityMaster 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?

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.


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


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-

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

QualityMaster 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 QualityMaster 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.

QualityMaster 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!