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Manufacturers who follow the CGMP regulations such as the pharmaceutical manufacturers need to perform process validation to ensure that all the drugs and medicinal products produced meet the quality standards as defined under 21 CFR 211.100(a) and 211.110(a). The validation cannot be effectively performed with a paper-based quality management system anymore especially when your quality teams are geographically dispersed.
It’s high time for manufacturers to consider shifting to the cloud-based QMS that simplifies process validation, enabling all the quality teams to contribute regardless of their geographical location.
Effectual process validation is significantly important for assuring the product quality – be it drugs or its ingredients. In the pharmaceutical industry, the basic principle for assuring quality is to ensure that the drug serves the intent. This principle checks for:
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Process validation is defined as the process of gathering and evaluating data from every single stage of manufacturing, from design to final production, that works as the valid evidence for ensuring consistency in the quality of delivered products. Validation includes a set of activities to be performed during the product and process lifecycle. Broadly, we can categorize those activities into three stages:
It is very important to understand that the success of any validation program depends upon the knowledge aggregated from the different stages including product and process validation. Such detailed information helps setting up the right approach to keep the manufacturing processes in control to ensure consistent quality of products as well as their attributes.
A comprehensive lot of information helps manufacturers to understand the loopholes in the processes and their impact to control the risks on the finished products and other relevant processes.
This induces the need for a scalable quality management system for manufacturers that can help them collect, analyze, evaluate, and utilize the quality information gathered from the different departments of the organization. Such a comprehensive system may help manufacturers to identify problems as well as opportunities for continual improvements.
In addition to pharmaceutical manufacturers, life sciences also face validation challenges. They are also progressively shifting to cloud-based environments for managing product quality while optimizing efficiency and costs. Another compelling reason to make a shift to cloud environments is the evolving tools and capabilities that enable users to control quality with utmost ease and flexibility. It further supports the culture of continuous improvement while maintaining compliance.
The cloud-based quality management solutions help to reduce the burden for the manufacturers since their quality teams often feel afraid of upgrading the traditional QMS system because of the associated extra efforts and tasks with the validation. However, there are still many companies that choose to go with traditional QMS without upgrades and making it harder for themselves to strive through competition.
Since the cloud-based quality management software is gaining traction due to sophistication, security, and cost-effectiveness, quality professionals should consider the advantages of implementing a cloud solution that complies with industry best practices, compliance standards, and security. This will help pharmaceuticals manufacturers and the life sciences companies to achieve product and process quality within the lowest cost of ownership possible that too with a simplified way of process validation.
With a cloud-driven quality solution, the regulated organizations can leverage next-generation technological advancements without cost-extensive upgrades and maintenance required in the traditional validation, which is also referred to as “heavy lifting” QMS solutions.
The cloud QMS solutions require no additional infrastructure setting. The QMS simplifies process validation easily through the use of common test protocols to check and verify requirements for installation qualification (IQ) and operational qualification (OQ). The solution providers have their team of validation experts that help pharmaceutical manufacturers to experience better validation process with the reduced amount of manual efforts and daunting tasks.
The removal of the traditional validation barriers has enabled companies to maintain pace with the advanced technological solutions and features that allow them to emphasize on innovation, market response, and continual improvement for ensuring quality products delivered every time.
According to research, process validation may result in unnecessary delays in the production process. It would be even more productive to go with a powerful QMS software like Qualityze that doesn’t require you to perform validation. They have their experts to perform validation so that you can focus on business core activities and ensure safer products to the market within the specified time.
Related Article: A Brief Guide to Process Validation
The FDA requires process validation, but it doesn’t have any particular guidelines or specifications to perform it. It also requires you to document the process validation steps and technologies you are going to use. The goal is to ensure that cloud EQMS you choose simplifies validation by helping you to;
Would you continue with traditional practices of validation? Or will shift to newer and improved cloud QMS simplifies process validation without extensive efforts?
One of the proven solutions to which you can consider shifting to is Qualityze Enterprise Quality Management Suite. Built upon the world’s most secure and reliable platform, Salesforce.com, Qualityze strengthens your quality management strategy by standardizing the processes and workflows throughout the organization while helping you to maintain a balance between operational excellence and quality.
Qualityze is a suitable solution for every industry including the highly regulated ones like Lifesciences, Healthcare, Pharmaceuticals, Aviation, and Defense, etc. It puts you in control of managing your quality processes while enabling you to collect and evaluate the information from the different parts of the organization. It also hosts amazing features like Email Approvals, Notifications, Digital Signature, Audit Trails, Reports, and Dashboard with advanced Analytics and Reporting tools that contribute to continuous improvements by offering detailed data, trends, and insights.
So, are you ready to align your quality processes with your business quality objectives without any validation hassles?
Author
Qualityze Editorial is the unified voice of Qualityze, sharing expert insights on quality excellence, regulatory compliance, and enterprise digitalization. Backed by deep industry expertise, our content empowers life sciences and regulated organizations to navigate complex regulations, optimize quality systems, and achieve operational excellence.
