Well-Defined Workflows & Processes, Key to an Efficient QMS

According to ASQ, a quality management system (QMS) is defined as:

“A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.”

In today’s rapidly changing world, quality leaders are looking to automate processes as much as possible, taking advantage of next-generation EQMS tools to truly integrate people, processes, and systems. But the first step to getting this “automation” right is to choose an EQMS that is flexible, so it can be customized as per your organization’s needs.

A common mistake quality leaders make is to force-fit their internal processes to suit the needs of the EQMS software.

However, it should be the other way around, wherein the EQMS must be set up to suit the internal needs of the organization. From a quality management perspective, the key benefits of establishing a clear workflow and a set of processes are:

• Standardizing Processes Drives Clarity: By standardizing processes, employees get greater clarity on their role, the set of tasks they need to perform, and the expected outcome.
• Optimize Resource Utilization: With a well-defined workflow, it is easier to plan better in terms of resources and drive efficiency into the process of resource allocation.
• Measure Performance: An effective QMS must be designed to track all metrics that matter. With a clear workflow, it is easier to measure performance and track all relevant KPIs, leading and lagging indicators.
• Continuous Improvement: Once the gaps are identified, it can help the team to identify ways to improve processes on a continuous basis.
• Training: The gap analysis can also help with understanding the skills needed to achieve the goals and develop training programs around them.
• Identify Risks: Process flows enable the detection of risks and implementing mitigative steps.
• Improve Visibility: It also enhances transparency and makes the flow of information across the organization a seamless process.

Looking for an EQMS to automate and streamline your quality management workflows? Looking to make life simpler for quality teams, despite complex requirements? Find out how Just – Evotec Biologics, a biotech company, streamlined its Quality Processes with ComplianceQuest’s Unified EQMS Platform.

A clearly defined process flow also lends itself to the automation of repetitive tasks, thereby freeing up resources to focus more on innovation and improvements. An enterprise-wide EQMS is essential to provide a unified view of all the processes to realize the benefits of process flow as well as automation.

However, often we come across organizations that implement automation in phases, limiting it to specific departments or building bespoke solutions that operate in silos. This renders harmonization difficult and makes informed decision-making a challenge. Using disparate systems inherently creates compliance and usability issues.

Benefits of a Unified, Next-Generation EQMS Platform for Process Management

Just – Evotec Biologics, a wholly-owned subsidiary of Evotec, enables global access to biologics with a focus on technologies that help discover innovative antibody candidates, accelerate development and substantially reduce their manufacturing costs. Right from the start, the company wanted to invest in a cloud-based workflow management system to improve quality. The management was aware that paper-based management can be a slow and daunting process, posing a hurdle to innovation and efficiency. To be able to streamline processes and reduce manufacturing costs, it needed an enterprise-level EQMS that was truly next-generation. The quality leaders at Just – Evotec Biologics also wanted an EQMS that was flexible, customizable, and scalable.

The company chose the cloud-based enterprise-wide quality management system from ComplianceQuest, built on the Salesforce platform, that allows the setting up of workflows and process flows within one platform. As a result, the company was able to realize the following benefits:

• Follow SOPs relevant to them
• Automate repetitive tasks
• Increased productivity thanks to ease of collaboration and AI-enabled features
• Reduced manufacturing costs

Workflow Automation with a Next-Generation EQMS

A cloud-based EQMS like ComplianceQuest can help businesses with a transparent and efficient automated workflow management system. This provides a unified view of enterprise-wide data for measuring and monitoring KPIs and driving continuous improvement.

The effective use of the QMS for automating workflows and process flows requires:

• Definition of processes to provide a high-level picture of how people, processes and systems interact with each other
• Establish standards and metrics
• Robust documentation
• Orchestrate the flow of information, data, and documents, with relevant authentication and authorization
• Collaboration and teamwork
• Capture requests, approvals, and action management
• Provide audit trails
• Improve compliance and streamline all regulatory requirements
• Enable escalation of complaints
• Track and monitor progress
• Report bottlenecks and trigger root cause analysis, CAPA

ComplianceQuest EQMS: Simplifying Complex Processes and Workflows

The ComplianceQuest EQMS solution has been designed specifically to integrate all the key processes in an organization, also aligning them with regulatory requirements for compliance. The features of the solution include:

• Change Management: The entire workflow from change request to risk assessment, its implementation, communication, documentation, and training are captured in the system
• Complaint Management: Businesses can have clear visibility over the complaint handling process from the time of receiving the complaint, to assessing the impact, performing CAPA to documentation and reporting
• Document Management: Documentation is an essential part of regulatory requirement as well as an efficient way of ensuring business continuity. The ComplianceQuest EQMS enables capturing the document management workflow from creation to reviews and approvals, storing, archiving, and destruction based on regulatory requirements.
• Audit Management: From scheduling to auditing, reports, and follow-up action, everything can be managed in the system
• CAPA Management: Performing root cause analysis and implementing CAPA can be automated for continuing improvement
• Equipment Management: The tools of the trade need a process flow right from purchasing as per specifications to periodic maintenance, which can be managed with the EQMS from ComplianceQuest
• Inspection Management: Enables a process-based approach to assuring quality of products and services
• Management Review: Facilitates conducting smart management review meetings with a tower of data to improve quality and safety systems
• Nonconformance: Timely identifying risks of nonconformance and improvement of processes based on gap analysis
• Risk Management: Helps manage operational risk tracking, evaluation, mitigation and monitoring
• Supplier Management: From onboarding to offboarding, control all aspects of supplier management
• Training: To propel organizational growth, identify skill requirements and implement focused training programs

The ComplianceQuest EQMS is modular, cost-effective, and allows end-to-end management of processes. It also can be integrated with ERP, CRM, and other enterprise systems to enable seamless workflow automation across the organization.

To know more about the EQMS and how it can improve your process flow, contact us now: https://www.compliancequest.com/contact-us/