New compliance guidelines and regulatory directives are released by federal agencies and International regulatory organizations on a regular basis. As a manufacturer, it makes you wonder – is it even possible to set up and fine-tune your quality processes to keep up with the challenges of these never-ending list of compliance directives and guidelines?
Not only is it possible, it is crucial to the success of your product. You just need the right resources to access and synthesize the heaps of regulatory information so that you can focus on the important stuff – like customer satisfaction and margin generation.
If your company produces products for regulated industries, you must have quality and regulatory strategies in place to ensure compliance. These strategies must be considered from the very beginning of the product creation process to ensure commercial success of your company. Finding the balance between creative efficiency and compliance with the many regulatory standards can be the difference between a deficit and profit. The companies that create quality products efficiently, without incurring standards violations, have a better chance of generating profits.
Critical areas for quality management and regulatory affairs departments include:
- managing quality processes,
- tracking product requirements, and
- recording compliance submissions and records.
Managing quality processes includes corrective action and preventative action, complaint management, nonconforming materials management, supplier qualification and review. Next, the process of tracking product requirements involves documenting any changes in design, structure, and assembly procedures. And finally, any violations or deviations in compliance must be recorded.
This can all be a little overwhelming. Thankfully, QuadRite’s RitePro provides a centralized location for all things quality, regulation and compliance. RitePro is an out-of-the-box application that can be deployed within days, instead of months. As a fully web-native application that is offered as a cloud-based or in-house solution, it minimizes your IT support needs and enables ease of information access and sharing across the extended enterprise.
RitePro lets you easily manage all of the following:
- Quality processes (e.g. CAPA, NCMR, supplier qualification, equipment calibration, etc.)
- Regulatory compliance processes and records
- Product definition and bill of materials
- Standard operating procedures and training
- Design control projects and phase gates
- Validation protocols and records
- Design history files, device history records and device master records
To learn more about how RitePro can help you easily comply with a multitude of regulatory requirements, visit our product page or contact us at firstname.lastname@example.org.