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The Importance of Change Control in the Pharmaceutical Industry

Chirag Panjwani on February 12, 2025

Change management in pharma industry

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

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

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

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

What is Change Control in Pharma?

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

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

Generally, changes occur in the following areas:

Production

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

Engineering

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

R&D

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

Quality Control

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

Quality Assurance

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

Cleaning process

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

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

Cycle of Change Control:

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

Types of Changes:  

Changes are broadly divided into two groups:  

Unplanned Change:

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

Planned Change:

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

Importance of Change Control in the Pharma Industry:

Change control importance in pharma industry

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

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

Regulatory Compliance:

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

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

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

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

Risk Management:

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

Documentation and Accountability:

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

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

Continual Improvement:

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

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

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

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

Product Consistency:

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

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

Operational Efficiency and Cost Savings:

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

Better Communication and Coordination:

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

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

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

Best Practices for Effective Change Control

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

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

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

Role of QMS Software in Streamlining Change Control Management:

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

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

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

Key Functionalities of the Change Control System are:

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

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

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

The Benefits of Quality Management Systems: Why You Need a QMS?

Chirag Panjwani on December 12, 2024

Benefits of quality management system

Quality is a diversified term used in day-to-day life! Whether it’s the products we purchase or the services we seek, our chief expectation is excellence in the quality.

An old business saying that persists till today- “Success of any business/organization hinges on these three pivotal elements: Price, Service and Quality”. Nevertheless, the underlying truth is that businesses find it challenging to achieve all the three simultaneously.

Striking a balance is intricate, as efforts to emphasize price and service often come at the expense of quality, and a focus on service and quality may impact pricing.

One way of ensuring that all the three factors co-exist is possible by adopting a Quality Management System.

A Quality Management System is a set of standardized procedures and policies that provides a structured approach to quality management, eliminating risks and improving processes organization wide.

How Quality & Standardization Came into Existence?

The roots of the term “Quality” can be traced centuries back when the Industrial Revolution took place. Earlier, only the standards that control the processes and products were used in the form of quality management systems.

Later, as the organizations and production quantities grew, the need for best practices, to ensure quality results, was felt.

Eventually, best practices for controlling products and processes were established and documented, which turned into standard practices and termed as “Quality Management System.”

It is also believed that the need of Quality Management became increasingly important after the World War II. This was the time when, bullets and rifles used to be manufactured in separate states.

So, to ensure their effectiveness and compatibility, without sacrificing quality, armed forces started incorporating best practices into their production and performing inspection using quality techniques.

Over the time, concerning the safety of consumers, a certification was developed under the name ISO 9001. Before getting this certification, a company needs to undergo an assessment by the third-party certification authoritative body, to ensure that organization is strictly adhering to these standard processes, procedures, and activities, maintaining quality management.

This helped them ensure quality, consistency, and accuracy throughout the production.

Still wondering how does a Quality Management System benefits organizations. Read on the remaining half part of the blog to know-

Explore the Unconventional Benefits of a Quality Management System

Benefits of quality management system

Fostering Consistency & Transparency-

A Quality Management System works justifying the phrase “Do what you documented and document what you do”, ensuring that every process is properly documented. This includes creating comprehensive documents, mentioning clear quality standards, such as Standard Operating Procedures (SOPs), work instructions, and guidelines etc.

This ultimately streamlines and standardizes the workflow, ensuring every step is executed with consistency, across the organization.

Reduced Defects & Improved Product Quality-

A Quality Management System categorizes various documents, and ensures that all the processes are being performed adhering to the set quality standards. This ultimately leads to minimizing the chances of errors and defects, improving the quality of the outcome.

Moreover, incorporating the practice of regular audits, inspections, and monitoring processes on various quality parameters, a Quality Management System helps to identify deviations (NCs), perform root cause analysis using the methods like Five Whys, Fishbone Diagram, Flow chart, Pareto chart, etc., so that corrective actions can be taken to prevent recurrence of issues.

Improved Communication-

A Quality Management System maintains a centralized repository of all the documents, including procedures and work instructions. This ensures that everyone has same information, and all the employees have a clear understanding of their roles and responsibilities, eliminating miscommunication and confusion.

Increased Customer Satisfaction-

Adopting a Quality Management System helps establish a culture of quality throughout an organization, right from top-level management to front-line employees. This ensures organizations to be customer centric, focused on fulfilling all the needs of customers.

Additionally, by offering a comprehensive solution, right from registration to resolution of complaints along with designating their source, priority, and severity, a QMS helps retain customers and increase sales.

Operational Efficiency and Cost Savings-

As discussed, since processes will be documented and standardized, workflow will be streamlined. Consequently, there will be less room for error, contributing to reduced wastage, increased cost savings, and enhanced operational efficiency.

Swift Risk Resolution-

The proactive approach of a Quality Management System to ensure that standardized processes are regularly followed across the organization helps identify, assess, and create a framework of steps to mitigate the risks related to compliance, safety, and product/service quality.

Assurance of Skilled Workforce-

A Quality Management System streamlines the complete training process right from helping identify the training requirements, maintaining record of trainees, scheduling sessions, execution, to evaluating performances. This type of comprehensive approach ensures that every employee stays updated by continually improving skills.

Additionally, it also aids organizations in assigning specific roles to specific individuals based on their results, minimizing the likelihood of errors.

Need to Switch to Quality Management Software-

However, a Quality Management System that relies on manual intervention becomes error-prone and time-consuming, resulting in inefficient operations. To avoid this, a Quality Management Software was developed.

It is a technological platform that allows to perform all the quality related operations and manage business crucial documents, digitally!

This tool automates and simplifies the core quality management processes involving:

  • Document management
  • Risk management
  • Training management
  • Complaint management
  • Audit management
  • SOP management
  • Inspection
  • Non-conformance management, etc.

Final Thoughts-

Adopting a Quality Management System (QMS) brings numerous benefits, fostering a culture of quality and continuous improvement within the organization. However, these advantages remain out of reach if quality management processes rely on outdated, manual methods.

To unlock the full potential of a QMS, digitization is essential—and that’s where a robust Quality Management System Software comes into play.

The real challenge lies in selecting the ideal QMS that offers all the essential features and aligns with your organization’s needs. Enter TecWork QualityPro—a cutting-edge, technologically advanced software crafted to digitize and optimize your quality management processes.

Packed with powerful modules, this next-gen, cloud-based solution ensures your organization stays ahead in maintaining and elevating quality standards.

No matter your industry, TecWork QualityPro transforms your quality management program, making it more efficient and impactful.

Have questions about implementation? Our team of experts is here to help. Contact us today and take the first step toward revolutionizing your quality management system!

All You Need to Know About Quality Audits in the Pharmaceutical Industry

Chirag Panjwani on November 7, 2024

Audit management system for pharmaceuticals

Quality audits are very crucial in checking compliance with regulatory requirements in any industry. In a pharmaceutical setup, these audits check whether the complex processes and procedures of your pharmaceutical unit follow the set standard.

For examples, let us assume that your pharmaceutical company is making paracetamol to sell in the market. It is only through quality audits that your consumers, and regulatory bodies will have assurance that quality of your product meets the standard and therefore they are safe and effective to use.

Quality audits are very complex and time taking process.  But if you know how to prepare for quality audits, and how to be prepared for an audit, most of your worries will go away.

So, in this blog we will discuss all that you need to know regarding quality audit in pharmaceutical industry and will look into the ways to prepare for your next or probably the first audit.

What Is a Pharmaceutical Quality Audit?

Pharmaceutical quality audit is the systemized examination to check if your pharmaceutical organization follows the processes and procedures which are compliant to set standards. It also examines if the pharma company is producing products which match the set quality standards.  

These quality audits also give feedback to the organization and find out the scope of improvement in process, procedures, or quality of the product to meet the standard of the market.  

The entire motive of any pharmaceutical quality audit is to verify if the products being manufactured by the organization are safe to use for consumers or not.

Types of Audits in the Pharmaceutical Industry

Pharmaceutical industry will have three types of audits:  

  • Internal audit
  • External audit
  • Unannounced audit

Internal Audit – as an organization you audit your facilities, SOPs, other procedures frequently.  Internal audits help to keep the day-to-day work and procedures smooth and without flaw.

With the help of an audit management system, like QualityPro’s QMS software for pharmaceutical industry, you can plan internal audits by managing audit schedules, creating regular assignments, and sending out notification to the right set of people.

External Audit– External audits are conducted by external parties. It can involve independent organization, like notified bodies and authorities. With the help of a pharmaceutical audit management system like QualityPro, organizations can easily conduct external audits, make reports, and send recommendations, if any, for further improvement.

Unannounced audits– Unannounced audits can be conducted randomly by organizations or third parties. The more complex is your manufacturing product, the more frequent can be such unannounced audits.  

These are generally conducted to ensure that standard conduct and procedure following is in the DNA of the organization and it is not induced due to any audit requirement.

Ways in Which Pharmaceutical Audits are Conducted

There are three ways in which pharmaceutical audits are conducted:  

  • On-site audit  
  • Remote audit 
  • Self-audit

On-site audit– It is the audit in which third party auditor visits your organization and reviews documents, procedures, and processes. It will interview your staff, will see facilities and check if your organization meets the regulatory requirements.  

Remote audit– Remote audit is very similar to on-site audit but with an exception. Auditor does not visit the site physically but visits the site virtually and connects with the organization via video conference. There has been a surge in remote- auditing post and during Covid due to various physical restriction. Like all other industries, audit also went remote, and this practice has become very commonly acceptable now.

Self-audit– Self-audit is the audit conducted by a department personnel to check if the department functions as per the set standards of quality, adheres to various laws, and functions according to SOPs.  

Generally, these personnels are department heads who do self-audit. Self-audits are generally conducted frequently to make sure that all boxes of quality parameters are checked.

How to Prepare for Pharmaceutical Quality Audit?

How to Prepare for Pharmaceutical Quality Audit

Preparation to audits can avert various chaos at eleventh hour. Hence, it is always advisable to be prepared for it. Here is some check list for smooth audit preparation.  

Documentation–  

Review all the past audits. Based on that, prepare a list of documents which consists of (but not limited to)  

  • Batch records 
  • Master formula records 
  • Standard operation protocols 
  • Change controls 
  • Deviation 

These documents must be current and must be validated and arranged.  

At such point of time, an efficient pharmaceutical document management system such as QualityPro comes into use. With the help of such a tool, you can easily arrange documents, create new documents, digitize documents, and make various versions (while keeping old versions).  

Prepare an audit plan-

Prepare an audit plan and prepare a flow of the audit. This plan of action will be provided to audit inspector.  

QualityPro by TecWork helps you to plan, define and document audit objectives, including the scope, purpose, and goals of the audit.  It can also help to schedule different audits to execute in near future such as ISO and FDA as per your convenience.  

Conduct an internal audit-  

Internal audit will do a dry run before final audit. This will highlight any loophole in the process, procedure before the final audit. Remember to deploy an independent team for internal audit to make the audit fruitful.  

Tips to Make Auditing Smooth: 

  1. Make sure that all the key personnels are available at the time of audit.  
  2. Provide a separate room for auditor. 
  3. Be on time.  
  4. Maintain professionalism. 
  5. Take notes of auditing.  
  6. Answer auditor’s all questions honestly.  
  7. Provide only copies of documents and not originals.  
  8. Don’t leave the auditor with your documents and notes.  
  9. Conduct an exit interview with the auditor after the audit.  
  10. Soon after the audit is completed, prepare for your answer for any discrepancy highlighted by the auditor.  

Pharmaceutical Audit Management Software Solution: 

Pharmaceutical companies depending upon old paper and pen-based model struggle and face lot of challenges regularly.  

Recording on paper-based system is a very long and time-consuming process and generally it is error vulnerable. Documentation errors can lead to regulation non-compliance. This can be costly for the company in terms of money, brand image and time.  

With the help of audit management software like QualityPro, organization can remove error-prone processes and digitize documentation recording process. It can offer tighter safety protocols, maintain audit trails, streamline audit workflow, and help organization to analyze findings and act proactively.  

It offers an intuitive dashboard to get all audit related information like past audits, open findings, critical findings, CAPAs etc.  

QualityPro for Pharmaceutical Industry Offers Numerous Benefits Like:

  • It simplifies complete audit process 
  • Automates all time-consuming tasks saving time and resources 
  • Ensures compliance regulations 
  • Identifies potential risk and vulnerabilities 
  • Helps maintain integrity throughout the organization 
  • Pinpoint he grey areas in your organization that need improvement

To explore and discuss more on the benefits of QualityPro by TecWork for your pharmaceutical company or to explore how aptly does it fit to your unique requirement.

The Power of a Document Management System in the Pharmaceutical Industry

Chirag Panjwani on February 21, 2024

document management system for pharmaceutical

“If it’s not written down, then it didn’t happen”.

Considering the context of our blog topic, this proverb fits perfectly. In the pharmaceutical manufacturing, documentation acts as a mirror to show what’s actually happening within the company.

Moreover, every pharma company must follow Good Manufacturing Practices (GMP). Equally important is the adoption of Good Documentation Practices.

Documents play a pivotal role in establishing consistency across operations and minimize the risk of misinterpretations and errors in communication, thereby ensuring improved product quality.

Adding to it is the need of managing hundreds may be thousands of formulas, both active and inactive along with their versions. Not to mention, regulatory bodies while inspecting a pharmaceutical manufacturing organization, precisely examines and validates all the documents and records, ensuring the processes, procedures, and products are adhering to the set industry standards, upholding the quality.

It is not overstating to say that in an industry like pharmaceuticals, where even a slightest error can have life-altering consequences for patients, documents act as the guardian of quality, safety, and compliance.

They act as the foundational stone for establishing quality management system in the pharmaceutical organizations.

However, a pharmaceutical manufacturing organization generates thousands of documents throughout the lifecycle of a product.

To manage such a huge volume of documents there should be a systematic and streamlined approach. And any system other than a document management system would succumb to errors and inefficiencies.

What is a Document Management System?

A document management system is defined as a systematic set of procedures and policies related to creating, capturing, storing, and tracking documents efficiently within an organization.

However, manual management of such a large volume of documents poses inherent risks and inefficiencies. Recognizing this, a crucial need for an automated document management software arises.

It eases the task of document management by providing a centralized, organized, and secured platform, enhancing efficiency of the tasks related to documents.

Features of an Effective Document Management Software-

An effective document management software encompasses a multitude of functionalities, elevating organizational convenience and streamlining operations.

Automating the Process of Document Management-

The software automates the complete document lifecycle right from creating to controlling, managing, organizing, and retrieving when required.

Moreover, it also manages multiple versions of documents separately, ensuring that only the Active version is being accessed by everyone.

Ensuring Timely Updates of Documents-

The software helps users to ensure that all the documents are up to date by providing alerts for expiry or whenever a document is due for revision/updates. It also sends notifications for release or pending approvals of documents.

Providing Easy Access to Crucial Documents-

By organizing all the documents at a centralized location, categorizing them based on file type, data type, and priority level, and allowing to search documents via metatags, a pharmaceutical document management software facilitates easy and quick access anytime, anywhere.

Ensuring Safety Through Access Control-

By enforcing access controls over the documents via passwords, a pharmaceutical document control software prevents from the risks of data theft or lost documents, ensuring tightened safety.

It also tracks all the activities performed on the documents, maintaining an audit trail of who and when viewed and modified the document.

Allows Effective Collaboration-

A robust pharmaceutical document management software enables such a capability that allows multiple people to collaborate and work on a common document without altering each other’s work.

Benefits of a Document Management Software-

When a pharmaceutical organization implements such an effective and capable document management software, it experiences immense benefits on multiple business fronts-

Benefits of Document Management System

Adherence to Compliance-

With an effective document management, a pharmaceutical organization will be audit-prepared every time with all the necessary regulatory documents, which will eventually lead to fewer compliance issues. This will even speed-up submitting documents for an Investigational New Drug Application.

Increased Operational Efficiency-

Today’s pharmaceutical industry demands an environment of agile decision-making and for this, critical documents accessibility plays a vital role. Enabling quick access to all the documents anywhere, anytime reduces the time usually spent on locating the required files, enhancing overall operational efficiency, and eliminating delays.

Maintains a Single Source of Truth-

By establishing a unified repository, a document management software for pharma industry ensures that all the stakeholders, researchers, and other employees access same information. This eliminates the risk of miscommunication between the departments that may arise when multiple documents are circulated.

Enhanced Security of Business Data-

Through role-based access, complete audit trail, and robust disaster recovery options, a document management software prevents loss or theft of data, ensuring high-end security.

Faster Time to Market-

A document management system (DMS) improves time-to-market by enhancing collaboration, ensuring version control, expediting approval processes, and facilitating quick document retrieval. With a centralized access to all documents of concepts and prototypes, automating workflows, and enhancing compliance management, a DMS accelerates the product development lifecycle, enabling faster delivery to market.

Final Thoughts-

Nowadays, pharmaceutical organizations that still relying on traditional (manual) practices of managing documents are likely to face a plethora of challenges.

So, implementing a document management software is the unavoidable need. However, choosing the right one is equally important for success. To your rescue come QualityPro’s Document Management System. It proves to be the perfect choice.

It is a comprehensive Quality Management Software with having robust and effective document management module that not only offers you the aforementioned functionalities, but it also allows easy integration with other quality related modules like Change Management, Standard Operating Procedures (SOP), Risk Management, Audit Management, Training management, Complaint Management, etc.

Ultimate Guide for Quality and Compliance Management 2024

Chirag Panjwani on January 4, 2024

Quality and Compliance are two pillars of a profitable business. How to ensure good quality of products and 100% compliance to norms? Take a dive to know.

Overview:

Quality and compliance, these are not just terms. For organisations these are mandates for existence. Although they have very little connection with each other on broad level, they are highly connected on a deeper level. They both impact the product as whole.

Consumers today are quality conscious. At the same time, they are equally concerned to know if the products they use follow the norms and standards or not. Therefore, these two attributes can make or break reputation of an organisation.

If quality and compliance are so important, then obviously, there must be some effective way to ensure that the organisation follow quality and compliance norms.

In this blog we will discuss quality and compliance at length. We will try to find out the possible Quality and Compliance Management Software which can help organisations to deliver quality product and yet remain compliant to the norms.

Stay on the page for full information.

What is Quality?

Quality refers to set of qualities expected out of a product or a service. It is a mixed effect of various factors like design, production, efficiency, safety, economy, timeliness and many more.

In other words, quality is a measure of how close it is to specific standards. It also stands for measure of how well a product or service meets its purpose.

What is Quality Management?

It is the process of overseeing the activities, tasks, and processes to produce each time a service or a product with set of expected quality. There are four components of it, namely:

  • Quality planning
  • Quality assurance
  • Quality control
  • Quality improvement

The process of implementing all four is called Total Quality Management (TQM).

What is Quality Management System (QMS)?

It is a system to document policies, processes, and procedures for achieving quality goals.

Since quality is a key differentiator in global market, implementing QMS is important to ensure that the processes run effectively and reduce cost for an organisation.

Benefits of Quality management system

Fundamentals of Modern Quality Management Systems:

Outdated QMS are complicated and have limited capabilities to cater to the present-day requirement.  Modern quality management systems are built on following fundamentals:

Unified application –

Fragmented and disconnected QMS system waste time and money. They put organisation at risk. Therefore, the QMS must have capabilities to unify all division of quality management, like document management, data analysis, training, and others.

One such QMS is QualityPro. This is a unified application having all the modules integrated and well connected with each other. QualityPro lets you:

  • Schedule training
  • Store and manage documents
  • Manage risk
  • Manage compliance and audits
  • Take corrective and preventive action

Visibility –

In the fast-moving business times, businesses must be aware of any significant risk right at the moment when they are happening, and not once the damage is done.

Modern QMS should include real-time visibility into all quality activities to eliminate delays in quality analysis.

QualityPro gives you a deep visibility. It lets you manage risk effectively. It is a full featured product designed to deal with unforeseen risk and help businesses to acquire a systematic approach to stay prepared against risks.

Based on visibility it provides, it flags nonconformance and allows you to take corrective and preventive actions to lower down such nonconformance in future. This way it mitigates possibility of triggering risk and nonconformance in future.

Control – Keeping important and sensitive data unprotected and accessible to everyone leads to many concerns. It can harm reputation of organisation and can cause financial loss.

Modern QMS such as QualityPro allows you to give conditional access to data, leaving away unauthorized access.  This way, it ensures data integrity.

Essential components of modern Quality Management Software Systems:

Essential components of quality management system

Modern QMS like QualityPro consists of all the above said modules, providing organisations surety of quality.

Now, as we have discussed quality, quality management and quality management system at length, let us steer towards compliance, compliance management and compliance management software.

What is Compliance?

In general, compliance means following to the rule. It is the state of being as per the guidelines. Definition of compliance also encompasses industry regulations and government regulations.

Companies and organizations today are being more and more compliance aware, because of increasing industry compliance norms, governments laws and consumer awareness.

Overruling compliance might result in huge penalties, cost reputation of the brand and deflect customers to competitors.

What is Compliance Management System?

There are various software which help you manage compliance with various regulations, standards, and legal requirement.

The software automates, consolidates, and streamlines an organisation’s compliance meeting processes. These are called Compliance Management System.

A compliance management system:

  • Manages compliance obligations of an organisation.
  • Automates various tasks in organisation, such as managing contracts or providing auditing tool for internal controls including documentation, report generation, etc.

Aim of a compliance management software is to provide staff with better visibility of compliance requirements and minimize possibilities of your organisation to be penalized.

Benefits of Compliance Management System:

Compliance management system has multiple benefits, like:

  • saving time by automating various processes like data collection, communication
  • tracking changes in compliance requirements
  • integrating the changed or updated compliance with the whole system

An efficient compliance management system like QualityPro (which is also an effective QMS) has many benefits, like:

  • Efficiently organise and manage information about regulatory environment of organisation. 
  • Easily identify which regulation apply to your organisation.
  • Automating repetitive tasks related to regulatory compliance across various departments of an organisation.
  • Saving from legal suites and penalties

QualityPro: Quality Management System or Compliance Management System?

QualityPro is a comprehensive Quality and Compliance management system. Loaded with the benefits of both, it is a Quality and Compliance software.

It is a modern software which makes sure that your products are good in quality and stick to the compliance.

By offering quality products, it helps attracting consumers and building brand image through its host of features like-

  • Supports food-related labelling and reporting requirements falling under FDA, FSMA, GMP, and such along with flagging of ingredients if their nutritional properties in formula exceed established industry standards.
  • Sticking to food labelling and reporting requirements, including GMP, FDA, GFSA requirements.
  • Supporting chemical related labelling and reporting including GMP, SARA Type III, REACH, HAZMAT, SDS, MSDS, INCI requirements.
  • Supporting special reporting of allergen and organic ingredients, as well as of Kosher and Halal products
  • Maintaining master batch records and other key audit records.
  • Graphical bi-directional lot traceability inquiries and recall reports.

On the other hand, by sticking to all the compliances, it is keeping penalties away from your organisation.

Thus, if you are a manufacturer and looking for a Quality and Compliance Management Software, QualityPro is a perfect solution.

To explore how it can benefit your organisation, feel free to connect to our sales team or visit our website.