FDA Inspections


Senior FDA / ORA Medical Device Investigator Offers Insights on FDA Inspections

MasterControl believes compliance is a state, not an event. With MasterControl, suite compliance becomes easy to manage with an easy-to-validate and easy-to-maintain web-based interface that incorporates industry best practices for every stage of the development cycle, ensuring that regulated companies are always ready for FDA inspections and audits.

FDA Just Called! Now What?

 

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How Can MasterControl Help with FDA Inspections?

The MasterControl Audit software solution can help medical device manufacturers attain and maintain cGMP compliance by automating, streamlining, and effectively managing quality audit processes before FDA inspections. Here's how the MasterControl Audit software solution addresses some of the major challenges of both performance and compliance audits.

MasterControl CAPA software is a robust, easy-to-use solution designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to GMP compliance such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that biotech and bio pharm manufacturers face in FDA inspections.

MasterControl Change Control software is designed to help medical device manufacturers automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project which may be inquired about during FDA inspections. Here's how MasterControl can ease some of the major challenges in change control.

MasterControl Documents document control software integrates with the MasterControl suite of quality management solutions. It is a configurable and easy-to-use software solution that helps medical device manufacturers attain and sustain cGMP compliance and adhere to QSR requirements and FDA inspections. Here's how MasterControl Documents addresses some of the major challenges that medical device manufacturers face in establishing and maintaining a document control system that complies with FDA approved cGMPs and 21 CFR Part 11.

MasterControl Training software is a robust, easy-to-use solution designed to effectively manage the training process and integrate it with other processes critical to FDA inspections, such as CAPA, change control, audit, and customer complaints. Here's how MasterControl Training software addresses some of the major challenges that medical device manufacturers face in establishing and maintaining an automated training management software system.

Regulated Companies can be "Inspection Ready" Year Round for FDA Inspections

With MasterControl's integrated electronic quality management system, regulated companies can be "FDA approved" every day year round. MasterControl provides a complete approach to FDA inspections includes the following configurable applications :

  • MasterControl Documents
  • MasterControl CAPA
  • MasterControl Change Control
  • MasterControl Training
  • MasterControl Nonconformance
  • MasterControl Audit
  • MasterControl Customer Complaints
  • MasterControl Forms
  • MasterControl Submissions Gateway

Each regulated company can pick and choose the applications they need to address the unique needs of their industry and company to get themselves ready for FDA inspections.

Time-Tested Implementation for FDA Inspections and Product Training Methods

With more than a decade of experience, MasterControl Inc. has developed time-tested implementation and product training methods to help companies employ software sooner, receive faster software ROI, and be ready for FDA inspections.

  • Implementation Services : MasterControl works with each company's IT department to deploy the implementation phase, which includes database configuration, installation, and configuration.
  • Product Training Services : MasterControl's Professional Services team, consisting of former FDA experts, ISO auditors, and IT system administrators, conducts product training at the state-of-the-art MasterControl Training Center in Salt Lake City. MasterControl experts can also provide training from customers' work sites. The product training services include system administration training, onsite training and configuration, a coaching program, and advanced training to be safe from FDA inspections.

Contact a MasterControl representative to learn more about the web-based, electronic software solutions that help streamline the tasks and processes associated with FDA inspections.