Why Quality Transformation is a Key Aspect of Business Transformation

A US-based manufacturer and supplier of packaging materials (blister packaging, bottling, specialized kitting, etc.) to pharmaceutical, OTC, diagnostics, and medical devices companies was using legacy QMS software to manage its quality management requirements. Since the company was serving the highly regulated life sciences sector, it had to be compliant with cGMP, FDA, and DEA requirements. Additionally, the product equipment had to be qualified for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).

The company faced several quality and compliance-related challenges, primarily because its EQMS Solution was fairly outdated. Some of the challenges were:

• It wasn’t easy to track status of compliance and quality metrics
• Data visibility and reporting
• Open Nonconformances (NC), CAPAs, and deviations were not addressed on time, leading the delays
• Overall quality and compliance process was inefficient

The company realized that it was time for an overhaul. To modernize its operations the company decided to implement a modern ERP and ComplianceQuest EQMS. The leaders at the company agree that this “digital transformation of the quality and compliance process one of the most important aspects of its business transformation efforts.”

With CQ EQMS, the company expects to transform its business operations for:

• Faster time-to-market
• Better and more efficient supplier management
• Continuous training
• Proactive risk management.

The company started the process of streamlining by implementing Document, Training, and Change modules, followed by Complaints, NC, and CAPA, and finally Audit and Supplier modules. Along with improving the operational efficiency of the organization, the EQMS is also helpful to improve overall customer satisfaction.

Cloud-Based EQMS Solution: A Vital Step for Overall Business Transformation and Modernization

Another US-based company which operates regulated facilities in the US and the UK, handles the procurement, storage, shipment, and labeling of pharmaceutical products to support their customers’ clinical trials. The company offers complete solutions around clinical trials for its partners.

This company used a paper-based quality system and opted for ComplianceQuest’s EQMS to digitize their quality processes as well as automate work. The areas of priority were document, training, and change, and in the next phase, the company was planning to implement audit, supplier, and risk to meet the quality standards of their clients, mostly big pharma companies.

There are several such examples of companies that are proactively embracing digital transformation – to improve overall business and financial performance. They have all realized that streamlining, automating and implementing a connected QMS software is a critical part of the process.

Transformation of the Quality Management System

The two case studies exemplify the increasing need for manufacturing and life sciences companies to automate their processes to improve:

• Operational efficiency
• Compliance with regulatory requirements
• Customer satisfaction
• Growth in terms of business/financial performance

In an increasingly globalized world, businesses are compelled to keep their manufacturing costs low without compromising on the quality and performance of their products and services. This has led to companies outsourcing different aspects of their manufacturing operations, sourcing raw materials from different countries, and reaching out to markets across the globe.

What they need is business transformation addressing the three pillars of people, process, and technology. To drive the transformation, they need access to holistic data that can improve decision making, accelerate growth, and strengthen competitive advantage.

To enable this, they need a unified platform on the cloud that enables the standardization of operations across sites, ensures the quality of the inputs, and facilitates compliance with the unique regulatory requirements of each country. Manufacturers therefore need to ensure the following:

• Visibility into their operations
• Making all their stakeholders aware of the company’s policies, products, and standards
• Empowering workers with modern digital tools that enable seamless collaboration
• Minimizing nonconformances
• Being proactive in responding to issues and challenges

Manual, outdated systems do not provide the required visibility and transparency. Also, manufacturers using such systems often have a reactive approach to issues as they are unable to capture trends or identify potential risks. Moreover, ISO-based regulatory systems need a proactive approach to quality to enable businesses to assess and address risks and minimize quality-related issues.

A cloud-based system such as ComplianceQuest EQMS, built on the Salesforce platform, enables businesses to transform their quality management and see a big leap in their business operations. The EQMS integrates with the organization’s other enterprise systems such as ERP, SCM, CRM, etc., thereby making operations transparent and visible.

Benefits of ComplianceQuest EQMS in Business Transformation

Being cloud-based, the ComplianceQuest Quality Management System ensures standardization, harmonization, and consistency of all quality processes across sites to ensure a quality-first culture. The access to unified data eliminates data silos and enables quality leaders and management to capture trends and assess risks for effective action. This helps with the proactive implementation of mitigative measures to minimize issues. Automation and smart workflows decrease errors and lower the cost of quality, improving the competitive advantage.

The CQ EQMS is aligned with ISO and other leading standards, which helps improve compliance. UI, AI-assisted workflows, and personalized user portals guarantee user adoption while scalability and reliability ensure business continuity.

Some of the key features that help transform the quality management system to modernize businesses include:

• Risk: Businesses can identify, rank, and mitigate risks proactively by capturing trends and using matrices to prioritize risks based on frequency and severity.
• Change: Continuously improve processes and assess impact to ensure new risks are identified and evaluated before they become major issues.
• Document: Automate the document workflows to minimize effort, improve access, and ensure version control.
• Training: Identify gaps and upskill employees to meet quality standards.
• Inspections: Proactively identify quality issues and be audit-ready.
• Audit: Assess the effectiveness of the quality management system periodically to improve compliance.
• Equipment: Implement preventive maintenance to minimize downtime and enhance the quality of products as well as ensure the longevity of machinery to increase RoI.
• Supplier: Manage and collaborate with suppliers using tools to increase supplier performance while reducing risk and cost.
• Nonconformance: Minimize nonconformances by ensuring products meet specifications and regulatory requirements.
• CAPA: Identify root causes and take corrective and preventive actions
• Complaints: Manage and respond to complaints effectively and efficiently to improve customer satisfaction
• Management Review: Take data-driven decisions for continuous improvement of business processes and the quality management system.

Learn all about Document and Learning Management: Digital, Data and People Transformation to Improve Compliance and Quality. Download the whitepaper here: https://www.compliancequest.com/whitepaper/document-and-learning-management/

To find out more about how ComplianceQuest EQMS can help with quality transformation, visit: https://www.compliancequest.com/quality-quest/