This summer, when you are thinking about the sun, sand, and barbeque, the last thing on your mind should be worrying about cGMP deviations affecting your operations. So, before you start packing your bags, make sure your deviation management plans are rock-solid, as Quality never takes a vacation. Being the Quality Assurance and Quality Control Specialists, your role is critical.
As you are the guardians of quality and patient safety. Non-adherence to the quality standards and regulations can lead to significant impacts, from product recalls to patient harm. As you plan to enjoy sunny days this summer, ensure you leave back a well-implemented, robust quality management solution.
Why Quality Matters Year-Round?
A well-established enterprise quality management system (QMS) ensures that any deviations from routine procedures are promptly detected, investigated, and addressed. Deviations can occur anytime. For example, equipment malfunction, sudden hiccup in production, human error, contamination etc. – it all demands instant corrective action by the Pharma personnel. If your company deviates from written processes and procedures, regulators require you to document the occurrence and either investigate or justify the deviation.
Compliance is simpler when these activities can be conducted quickly and without hassle. Hence, to have a digital Corrective Action Preventive Action (CAPA) module is important to instantly correct and prevent the recurrence of quality deviations, ensuring product quality, safety, and importantly, compliance with FDA regulations.
Act quickly, act smart: The importance of timely action
Time is a major deviation factor. Whether it is human error or equipment failure, prompt action depends on timing and informed decision-making.
When a deviation is detected, a thorough investigation is needed to identify its root cause. To gain insight into what went wrong, it requires a thorough investigation of data, reviewing each step, along interviewing key personnel assigned to those tasks.
By taking prompt corrective actions, pharmaceutical companies can ensure quality assurance in batch manufacturing, following of correct processes, and maintaining the highest standards of product safety and compliance in manufacturing.
Make deviation management easier with modern digital solutions
In this era of digital transformation, to achieve Pharma 4.0, quality assurance solutions play a significant role in deviation management.
Modern quality management systems come with advanced analytics and reporting capabilities, providing comprehensive dashboards that display key performance indicators.
(KPIs) and metrics in a manageable format. This allows teams to see trends and abnormalities faster, facilitating decision-making and corrective action.
As per the Report by McKinsey, “Digitization and Automation have resulted in more than 65 percent reduction in overall deviations and over 90 percent faster closure times.”
Automated alerts and reports ensure deviations are flagged immediately, reducing the time between detection and response. This extensive inspection simplifies deviation management and gives time to enjoy a stress-free summer while providing a robust cGMP deviation management solution.
Through cloud-based platforms, team members can also access and share information from anywhere, providing a more collaborative approach to deviation management.
EPIQ by Caliber: Your shield for deviation management
EPIQ by Caliber, is an enterprise platform for integrated quality management. Designed with modern architecture, EPIQ is a beacon of quality excellence. Its single sign-on functionality can consolidate silos of data from multiple applications into a single system, ensuring robust deviation management and delivering seamless quality.
Designed specifically for the pharmaceutical and biotechnology industries, EPIQ ensures compliance with ALCOA+, GAMP 5, 21 CFR part 11, and other major regulatory standards to build a solid foundation for better thinking.
While empowering the Pharma Industry with analytical data, it also builds a solid foundation for quality metrics. So, while the season is synonymous with relaxation and fun, it may also be a time to actively improve the quality of your company’s quality performance.
Here is to a successful deviation-free season!
