Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
You need to manage your quality system, and you might think you have everything under control with a manual process. But manual processes including disparate tracking systems for controlling documents, deviations, customer complaints, change controls, and other quality processes are often cumbersome and difficult to control, with limited to no visibility across processes.
So when is it necessary to bite the bullet and adopt an automated enterprise quality management system (EQMS)? The timing may not be the same for every organization, but you should examine your quality management processes and see where automation and quality management software can help fill in the gaps, creating a more cohesive closed-loop process and better preparing you for any internal audits, regulatory inspections, or regulatory reporting.
Identify the Driving Force Toward Automation
Knowing what pushes you toward a better process can help guide your decision process. Which category does your organization currently fit?
You Failed an Audit You Need a Solution Yesterday
You’ve failed an audit or received a citation. What now? Automated EQMS can help you control your quality management records. It can put deliver information at your fingertips to help identify gaps in documentation, document controls, open complaints or CAPAs, and other items that need to be addressed ASAP to keep you compliant. The same rules apply if you have a growing supplier network and have too many items to track manually. You need a solution yesterday to streamline your quality system, increase visibility into your global quality records, and prove to the regulatory agencies you have a well-managed quality management system.
Your System Lacks Control You Need a Solution Today
Your quality operation consists of disparate systems, disconnected processes, or spreadsheets. Employees don’t know which records need approving or what needs an effectiveness review. You’re losing track of documents or tasks. Your processes are not consistently followed, and you live in fear of failing an audit. You need to gain control of your quality management system by implementing EQMS today.
Your team needs information on what needs to be completed. An automated quality management solution can provide dashboards to see into the system, displaying individual tasks for your employees. EQMS creates a closed-loop process for you by automatically aggregating items that need to be addressed by your team members. In addition, the system can automatically send emails and reminders to escalate items that have yet to be completed or require additional follow-up.
Your Team Wants Better Visibility You Need a Solution Today
Your management team cannot make decisions quickly. They don’t have the information they need to drive continuous improvements. They lack insight into what is going on with quality records and have difficulty finding the information needed to initiate quality improvement. You need this information today, and EQMS will provide it.
Automated quality management software can provide reports to show trends in your quality management records. This empowers your management team to make the necessary decisions to lead the organization toward its global quality vision. In addition, reducing manual tasks and the tedious process of relating data in multiple, disparate systems creates more time to focus on improvements. Automated EQMS can result in fewer CAPAs, audit findings, and misplaced or outdated documents. Simply put, it gives you better control and visibility of your quality management system.
You Anticipate Growth You Need a Solution Tomorrow
Your products are gaining traction in the market, and you need to track higher volumes of production, more customer feedback, global operations, and your growing number of global suppliers. It’s just too much information to manage with spreadsheets and manual processes. Start researching and budget for a solution. You will see a need for automated EQMS to close these gaps tomorrow.
Automated quality management software can grow with your business, scaling to meet your needs. It can enable you to capture information on all your incoming inspections, all your documents, training records, complaints, audits, CAPAs, nonconformances, and changes—regardless of how much data you need to track. EQMS puts you in control of your quality management system, which better enables you to guide your organization’s growth and expansion.
When to Automate
This leads us full circle to our question of when to automate. The answer, it seems, is best revealed within the context of timing. It’s not an issue of “should we automate?” but rather “which of our organization’s problems will EQMS address and when is the best time to implement it?” With regulatory bodies keeping Life Sciences organizations under the compliance microscope and the need to be prepared to provide records during an inspection, a growing business should eventually move toward automated EQMS to meet its global quality goals.
When you are ready to research automated quality management solutions, we invite you to check out SmartSolve. Our compliance-ready platform will make it easier for you manage critical quality management processes.
Learn More About EQMS
Facilitate compliance with closed-loop integration between quality management processes.