21 CFR Part 820

Improved Document Control

A 21 CFR 820 Certified QMS Software like Qualityze offers a centralized location to store all your business-critical documents and manage them. Once the documentation process is managed well, you will be able to save yourself from loads of efforts to meet compliance. Each document’s revision history allows you to keep better control of the process.

Better Employee Training Programs

Implement a certified FDA 21 CFR 820 Software in your organization to help you create better employee training programs based on the complaints and defects, Corrective Actions and Preventive Actions, and work instructions to ensure that employees are competent enough to perform the designated role and responsibilities.

Effective Audit Management

FDA has mandated the regular audits for the medical device industry in order to keep a check on the effectiveness of quality processes and system. Certified FDA 21 cfr 820 system software can help you comply with regulatory standards by enabling you to define, schedule, and conduct audits. The software will also enable you to analyze audit findings, implement required action plans, and conduct effectiveness check for the actions plans implemented.

Efficient Tracking and Reporting

Effective tracking and reporting support well to comply with FDA requirements. It’s high time to get a certified QMS tool like Qualityze that can help you to track all the processes efficiently and to prepare detailed reports on trends and factors affecting the quality of products, processes, and systems.

Improved Supplier Quality

The regulations cannot be met by ignoring the aspect of supplier quality management. Make sure you get a powerful quality management software like Qualityze to control supplier quality without harming or delaying the current processes. Qualityze supplier quality management helps you manage supplier records and track their performance for better traceability.

Robust CAPA Processes

Having an effective CAPA process is also an essential part of FDA compliance. You need the intuitive QMS tools that can help you link nonconforming records to CAPA processes to implement right action plans and can perform the risk assessment to ensure that the implemented CAPA is effective.

Better Risk Management

Risk assessments are generally done to record the why behind the important business decisions. Get a QMS tool that helps you perform a thorough risk assessment before implementing any action plan. If you will maintain such commitment, you will shine through every quality management activity you perform afore regulators and consumers. You can just ensure conformity with ISO 13485 only, make sure you have FDA 21 CFR Part 820 to attain compliance for your medical devices. Want to know more, get in touch with our technical team today. Current Good Manufacturing Practice (cGMP) governs the practices used in designing, manufacturing, labeling and packaging, and servicing of finished devices that are intended for human use. Additionally, the cGMP also governs the facilities requirement for manufacturing and storing environment.