Achieving Quality Management with Incremental Steps
For pharmaceutical companies who want to implement an electronic quality management system (QMS), we often recommend focusing on three specific modules to start - Corrective Actions (CAPA), Deviation Handling, and Change Control. These modules are core to quality management and will bring tangible benefits to the organization quickly.
What are these modules, and why are they so important?
Corrective and Preventive Actions (CAPA)
What it is: CAPA is a process for identifying, correcting, and preventing issues to improve quality.
What happens: A CAPA process monitors processes and identifies the root cause of a problem. It then recommends corrective actions to address issues. Once the corrective actions are made, the process monitors their effectiveness and prevents recurrence.
Why it's important: A CAPA process enhances product quality and reduces the risk of future issues.
Deviation Handling
What it is: Management of any departure from standard procedures or specifications.
What happens: A QMS records an unexpected event and helps you investigate its root causes and impacts. You can then implement corrective measures and document resolutions. Using a QMS allows you to more easily engage all key stakeholders in the organization through system notifications.
Why it's important: Deviation handling helps maintain consistency and quality and provides a clear audit trail of what happened and how it was resolved.
Change Control
What it is: A structured approach to managing changes in processes, equipment, or documents.
What happens: Documenting proposed changes in one location allows you to evaluate them quickly. You can assess the risks and impacts as a team and approve, implement, and document changes.
Why it's important: You want to minimize disruptions to operations. A Change Control module ensures controlled implementation of changes. It also enhances traceability and compliance.
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All three of these modules help pharmaceutical companies improve quality and compliance efficiently. So, start small, achieve quick wins, and lay a strong foundation for future expansions of your QMS.
Read more about why you should start with these three core QMS modules.
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We are deeply committed to helping customers leverage world-class software solutions to drive dramatic improvements in quality, regulatory, and content-management processes. Check out our?full suite of quality, training, document management, and regulatory solutions?to automate and optimize end-to-end processes and deliver maximum impact. With decades of experience with some of the largest and best-known pharma companies in the Middle East and Africa, Brazil, and South America, we work hard to bring best practices and a pragmatic perspective to every customer’s implementation of their solutions.
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