A customer complaint means any written, digital, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, and performance of a device after it is released for distribution.
Digital complaint management is designed to optimize customer success, satisfaction, and retention.
Most organizations operate with unique processes that are difficult for point solutions to address. A customer complaints management system must facilitate regulatory compliance and yet adapt and address unique requirements to positively impact operations. A highly configurable system enables organizations to enable continuous improvement that improves product quality and customer success. Go beyond compliance by leveraging a configurable customer complaint management system designed for your organization.
The Intellect CAPA Analytics console offers a dynamic and real-time report on all CAPA activities created, in progress and closed by the user. Analytics and charts are provided on a company level providing valuable into all corrective actions by year, location, and classification, complaint disposition and escalations to nonconformances and CAPAs.
An automated customer complaint management system can be set-up to automatically alert FDA and global regulatory agencies about nonconformances.
In the case of medical device and drugs, complaints about death, serious injuries and adverse reactions that come into a complaint management system must be reported as required.
21 CFR Part 820.198 and 21 CFR Part 606.170 require a formal complaint handling process, which can be facilitated by Intellect.
Quality, compliance, safety, risk, efficiency, and costs are impacted in addition to poor customer communication without a proper Customer Complaints Management software system in place. Intellect QMS includes change management, automation, version control, and workflows to communicate, acknowledge, track, and then implement any requirements.
Our solution increases customer success, improves product quality and safety, reduces product recalls and ensures compliance. The ability to integrate with over 500 systems and highly customizable workflows provides unlimited versatility.