With the growing competition, quality leaders are trying innovative ways to enhance the product/service quality. Quality is not an option, and in fact, it does not happen by chance. It is a prerequisite for any organization to function efficiently and satisfy customer needs. A systematic process of managing quality is called standard operating procedures. Every organization member follows this framework to ensure consistent quality; QMS (Quality Management Software) with artificial intelligence and analytics enhance quality consistency.

Quality Management Software

Quality Management Software is designed to document processes and procedures and streamline quality policies in compliance with ISO (International Standards Organisation) and the FDA (Food and Drug Administration). It helps organizations to deliver quality products and achieve customer satisfaction. The benefit of an effective Quality Management System for an organization is ensuring process efficiency and providing procedural structure for several functions of work that are adopted and followed in the organization’s processes for delivering quality products. Furthermore, QMS software enables effective adherence to compliance regulations.

This blog will read about seven core elements of Total Quality Management Software that organizations can adopt. These elements would benefit the organizations immensely by enhancing their alignment to compliant and regulated quality processes.

Role-Based Access Controls

An efficient Quality Management system has advanced access controls that restrict organization documents, processes, and traceability based on the employee’s roles and responsibilities. Quality Management Software allows several levels of access controls wherein the users can access the information to perform their work as defined within the process. The QMS is configurable to define broad and granular rules like when a user should have access to a specific piece of data, what they should access and not. The role-based access controls enable organizations to enhance operational efficiency by securing sensitive information in adherence with compliance.

Structured Storage of Data

QMS software helps the organization to structure and organize their data efficiently. The QMS is equipped to retrieve data easily for inspections or/and when auditors need specific pieces of information to save time and accuracy. The QMS has configurable fields and forms that enable the users to understand the data better and ensure no information is missed. The structured data plays a significant role in identifying the actionable insights and regular patterns that impact an organization’s performance as the data tracks the missing, incomplete, or known errors.

Clear Process Definitions

QMS of an organization is subjected to the product life cycle streamlines the workflow path. The responsibilities are defined to correlate with the standard operating procedures and deliverables of achievable goals. The workflow status, process documents, and records include data management as it is the critical factor of QMS success to derive constant improvement and quality products with corrective, preventive activities.

The inefficient process definition leads to redundant issues, overlapping CAPA’s and NC’s, leading to deficit product quality, compliance risks, poor brand reputation, less customer satisfaction, and loss. An effective quality management software provides data evidence of the process followed. Clear process definitions enable users to use the QMS more efficiently and help them understand what calls for a CAPA (Corrective Action Preventive Action) and what calls for an NC (Non-Conformance) to reduce unnecessary escalations of issues.

Documentation – Management and Control

The document management and control refer to all documents or records related to internal and external communication, measuring tools, analysis, evidence, training, and knowledge sharing. It includes the lifecycle of events, what stages they are in, procedural documents, how the loop is closed and how the issue relates to other problems in the organization, the real cause of the case, and how it can be corrected and prevented. QMS records prescribe document management methods and keep supporting information, investigation, and root cause analysis methods for easy auditions within compliance and regulations.

Design Controls

All tools, equipment, instruments, and calibrations are required to create a medical device or product to be thoroughly checked as every minute detail matters. These have a set of quality practices and procedures managed and controlled as per the industry guidelines to ensure the delivered product meets the intended purpose. As most product recalls cause calibration errors or issues in other design control parameters, the implemented QMS should provide an efficient way to handle design controls and implement the same during the manufacturing process. It will help the organizations reduce their non-conformances and product recalls/scraps caused due to calibration errors.

Analytics/Reporting Insights

Quality processes can be significantly enhanced if swift actionable business insights are shown. A few examples of fundamental insights include the number of issues found, users working on it, the effectiveness of the problem, frequency of a specific set of root causes, most frequent source of the issues, product codes with the most and most minor issues, etc. This will give a clear picture of crucial deliverables which are tied to a process. This way, QMS help organization manage and identify potential issues and patterns. The actionable insights of the QMS make the organization truly efficient and productive by improved decisions fostering a culture of consistent improvements.

Open Channels for Feedback

The goal of QMS is to deliver a qualified product that is reliable and safe to use by end-users, enhancing customer satisfaction and brand reputation. The methods of handling a customer complaint concerning measurable goals can vary. QMS provides a way for customers to log complaints, give feedback so that organizations know the ground reality of its products. With the proper methods of investigation, corrective measures, and preventive measures, QMS brings in quality-driven culture, customer satisfaction, and continuous improvement in procedures.

Final Thoughts

The aspects mentioned above are the critical elements of a QMS in an organization to achieve the desired quality results in absolute terms as defined by the standard regulation board. The QMS built to service organizations to achieve their best quality by simplifying the complexities involved and producing consistently high-quality products.

QMS for Life Science Industry

Compliance Group QMS is a SAAS (Software as a Service) based QMS application designed especially for life science industries in alignment with the compliance regulations (21 CFR Part 11, ISO 9001:2015). It has a power-packed QMS (Quality Management System), and DMS (Document Management System) interlinked and integrated with analytics. The platform is user-friendly and straightforward with clever configurational aspects as per the needs of an organization and the industry type and built to scale and pay per use model.

Connect with Compliance Group today at sales@complianceg.com or call (847) 327-3167, Ext. 406.