In today’s fast pace environment companies are always looking for ways to gain the competitive advantage. While most dump budgets towards R&D the cost of additional head count, improving technology or purchasing competitors are huge investments. An often overlooked simple fix is to improve internal processes. Monetizing your existing investment can be easier and far less expensive than most think.
Oracle’s Agile PLM is the first step.
Transforming your manual process to an ISO certified proven automated management system is essential. Typically your quality system is the epicenter for maintaining controlled processes, auditable archives and metrics for each requirement of FDA regulations. As you company grows managing these in manual processes become time consuming and cumbersome. Companies use Agile PLM to manage, control and automate any and all records relating to your products.
Agile PLM provides the deep integration to capture Corrective and preventative action, Production and Process controls, Equipment and Facility Controls, Design Controls, Material Controls, Supplier controls, Change control and all product documentation and records. The inherent value behind implementing Agile is that it provides the ability to leverage the product data to manage all quality. It links your quality events to the product records showing the root cause, the impact and creates a clear path of what needs to be changed. As well Agile can manage your regulatory and compliance requirements and program manage all of your regulatory submittals and clinical trials.
Another pain point for companies’ manually processing documentation is maintaining a device history file. Keeping track of every interaction of the product throughout its lifetime from conception thru end of life is a requirement especially when going through FDA audits. Agile PLM becomes your device history file keeper. It will record when a specific employee logs in, changes or updates documents and logs out. It maintains a full revision history and can associate all changes and quality incidents that follow the lifetime of the product.
An added advantage Agile PLM provides is its analytics and reporting capability. Making the right decision at the right time depends a lot on the information available. Executives demand for critical information is increasing dramatically. Agile provides a rich array of real-time dashboards, metrics and reporting features that provide critical information faster. Providing quality trends helps improve overall quality, reduces risk and provides better customer experience.
Meeting the requirements of CFR Part 11 and Part 820 regulations can also determine the success or failure of a medical device manufacturing company. Agile not only complies with the quality system regulations but fulfills the CFR Part 11 requirement to support the required password protected signoffs, authorized electronic signatures and history tracking for complete electronic audit trails.
Whether you are a start-up or well established medical device company the need to control your processes will enable yo
ur quality organization to successfully improve your product development, manufacturing and customer experience. Agile PLM has allowed companies to achieve rapid growth, improve profits and provide the backbone to comply with all of the increasing FDA requirements.