Streamlining Complaints Management for FDA compliance

Recording, investigating, and reporting complaints in a systematic manner are a critical business processes for drug and device manufacturers to ensure compliance with 21 CFR Part 211 and 803. Companies marketing products in the EU have to also adhere to directives such as the European Medical Device Vigilance (MDV) System for incident reporting and investigation.

Quality and compliance managers are finding that point-solutions and spreadsheet-based systems are inadequate for managing the complaints handling process. Issues such as incomplete records, delayed investigations, poor status tracking, limited data analytics, and inefficient regulatory reporting are major hindrances for a growing organization. They are looking for ways to streamline the complaints management process for consistency, transparency, and efficiency.

In this webinar, we will review common bottlenecks and productivity issues in complaints management and demonstrate key capabilities of the MetricStream Complaints Management solution that address them.

• Lower cost of regulatory compliance with streamlined and consistent complaints handling
• Accelerate complaints recording, investigation, reporting, and closure cycle with automated workflows
• Gain enterprise-wide visibility into the complaints data and track the process with performance metrics
• Improve communication and teamwork on complaints across departments and functional areas
• Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process