Biotechnology quality management primarily requires streamlining, managing, and optimizing quality documents such as standard operating procedures. It helps them prevent compliance risks while increasing the overall efficiency and productivity to achieve quality goals and customer satisfaction.
Hence, they cannot just implement any EQMS. Biotech companies need a fully integrated and powerful quality management software to help them take a comprehensive approach to manage all the quality process efficiently and timely. The FDA has also released a guidance document ICH Q10 for biotechnology enterprises that reflect the best quality management system model. It includes the following set of requirements:
- The document shall contain the commitment from top management to make use of the quality system and continuously evaluate its efficiency in achieving the quality goals. However, to ensure the proper use of a quality system also requires organizations to provide employee training.
- The document shall be defined with all the organizational quality policies, describing the strategies and how they contribute to achieving compliance requirements. It will provide your employees with a much clearer picture of their roles, responsibilities, and KRA’s so they can actively participate in critical activities like system improvements.
- The document shall be detailed with planning oversights – answering what, why, and how of every quality activity to the employees. It will help your employee to map the resources required for performing a task.
- The document shall highlight how the organization will manage its resources and its application.
- The document shall demonstrate a good communication strategy to be followed across the organization. It will give your employees the right direction at the time of need. For example – if a production issue arises, who will be reported, and what will be the next steps for immediate resolution, approvals, and much more.
- The document shall outline the provision of the periodic reviews for the quality system to keep a check on its suitability and effectiveness, especially when you have introduced new policies or made some amendments to the existing ones.
- The document shall include the management of outsourced materials to keep a check on the consistency of quality. A minor component change can drastically change the quality of the final product. Hence, the document shall guide the employees to communicate with suppliers and vendors often to cope with the changes efficiently without harming the product quality.
Aren’t all the requirements implying the need for an integrated enterprise quality management software that can help biotech companies to create a closed-loop quality system and manage all their quality processes efficiently?
An Integrated Enterprise Quality Management Software for Biotechnology companies brings along numerous benefits, which are categorized into three main benefits, including:
1. Internal Benefits
The internal benefits that organizations experience internally include increased efficiency, improved productivity, and reduced costs of quality. Internal benefits include:
- Consistent Operations
The QMS implementation helps biotech companies to achieve stability while ensuring operational consistency since inconsistency is the biggest enemy of a sound quality system. Inconsistent processes can negatively impact organizational efficiency and productivity. Industry research even shows that unreliable business operations and processes can affect quality product delivery.
A quality management system requires organizations to define quality policies and SOPs clearly and concisely. Following the quality, documentation reduces the nonconformances while maximizing the overall operational efficiency and productivity. You are likely to leverage many measurable benefits, including reduced process cycle times, lesser customer complaints, and improved analysis.
- Continuous Improvements
Continuous improvement is among the most fundamental principle of implementing a quality management system. With continuous improvement, an organization is likely to experience better performance, strategic and competitive advantages, and employee engagement. However, you need to train your workforce on the basic principle of PLAN, DO, CHECK, ACT to maintain the continuous improvements and leverage its benefits for the long-term.
This will improve your workforce’s ability to problem-solving and innovating effective resolutions for quality issues.
- Smooth Communication and Onboarding
In any industry, including Biotechnology, supplier communication, and onboarding is the critical process that gets overlooked more often. Implementing a comprehensive quality management system enables you to take care of every aspect of product quality right from where it all starts, i.e., the supplier processes. You can also integrate a supplier quality management system with your quality system to make the supplier communication and onboarding processes smooth.
- Improved Decision Making
A quality management system helps standardize your quality processes. It further enables you to achieve quality objectives, providing you the complete ins and outs of the quality system to make informed decisions.
An eQMS system also provides improved transparency through the processes, critical data, and information that enables organizations to eliminate the risks of non-compliance, nonconformances, and other product quality issues in real-time.
2. External Benefits
The external benefits are the ones that organizations experience in the marketplace, such as increased market share, better sales, and increased customer base. External benefits include:
- Increased Profits
A quality management system supports the organization’s profitability by reducing the totals cost of quality and limiting the expensive product recalls. An integrated quality management system enables you to plan and schedule all the critical activities such as audits, equipment calibration and maintenance, document change, and much more, resulting in expensive failures of the production cycle.
As they say, “Every penny saved is a penny earned,” it goes well with quality management for biotechnology as well as other industries.
- Improved Customer Satisfaction
One of the most prominent advantages of implementing a robust quality management solution is improved customer satisfaction since you can improve the planning process. If you strive to meet customer requirements, you will have more repeated customers, as keeping your customers happy and satisfied is critical to maintaining a loyal customer base. Also, satisfied customers tend to recommend your brand more often. Hence, focus on customer satisfaction for improved revenue and brand recognition.
3. Signalizing Benefits
The signalizing benefits generally include improved brand reputation and recognition. Signalizing benefit includes:
- Improved Brand Reputation
When all the processes are consistent and are managed well, the enterprise is likely to deliver quality products within specified timelines. Such a commitment to quality best practices and product delivery timelines will eventually help improve brand reputation. However, the enterprise must maintain a culture of quality internally to gain signalizing rewards.
Would you still continue with traditional practices and quality systems to ensure biotech products’ quality when you can take the biotechnology quality to new heights?
If you want to experience the technological difference, you must go for a powerful EQMS like Qualityze EQMS Suite for Biotechnology. It is specifically designed to enable biotech companies to achieve quality, compliance, and operational goals while providing them greater control and confidence in managing the critical documentation.
Built on the Salesforce.com platform, Qualityze ensures greater flexibility, security, and accessibility. It comes with truly amazing features to complement your quality systems, such as advanced reporting, personalized dashboards, configurable workflows, intuitive user interface, electronic signature, alerts and notifications, email approvals, tasks scheduler, and much more.
For complete product insights, book your demo right away. If you have any other questions or concerns about implementing quality management software for biotechnology, get in touch with our customer success team on 1-877-207-8616 or write to us at firstname.lastname@example.org, and we will be right there for you.
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