Complaint Management in LuitBiz QMS

The Current Good Manufacturing Practice (CGMP) regulations of FDA and ISO quality standards require companies to have a formal complaint management system in order to ensure compliance. Complaint management is crucial as it alerts regulators about potential quality issues and allows regulated companies to address issues quickly. Companies use complaint management software in order to ensure compliance, be audit-ready, and provide a timely response to quality problems. The complaint forms management feature of LuitBiz QMS helps companies worldwide to achieve these objectives.


Complaint Management Challenges and how LuitBiz QMS can help

Without LuitBiz QMS

With LuitBiz QMS

Inefficient paper-based forms
Paper-based complaint forms require a lot of administrative time and effort to track and solve issues. Additionally, errors in manual data entry might lead to delays in complaint disposition.

Efficient digital forms with full traceability
The complaint forms of LuitBiz QMS makes the complaint management process very efficient right from the registration of complaints to its solution through its automated workflows.

Lack of Standardization
In traditional paper-based and hybrid systems, complaints are registered through various sources like phone calls, emails, social media, etc. The lack of a standardized process to record complaints makes it more difficult to comply with required documentation.

Standardized Process
LuitBiz QMS allows companies to standardize their complaint forms in accordance to the SOPs. Standardization makes it easier for everyone in the organization to comply with requirements.

Disconnected Systems
In traditional paper-based and hybrid systems, complaints are not connected to the associated CAPA and other non-conformance and quality forms. This lack of connectivity causes delays in complaint resolution and requires extra vigilance on the part of stakeholders.

Connected System
The integrated forms feature of LuitBiz QMS allows the complaints forms to be interconnected to the necessary CAPA and relevant quality forms. This connectivity makes it easier to map the complaints to non-conformances or other quality events.

Lack of Transparency
In traditional paper-based and hybrid systems, complaints logged from various sources are difficult to trace as the information is not transparent. Additionally, tracing down the paper documents during a compliance audit is a difficult task.

Increased Transparency
The complaint forms of LuitBiz QMS makes the complaint management process for both users and auditors. The reports and dashboard alerts make complaint data easily accessible and easy to use.

Low user acceptance to transition
In certain complaint management software systems, the complaint forms are already designed in the system and the users are forced to use those forms. Those forms might not be following their SOPs. So they either have to change their SOPs or compromise on the data entry. This leads to low user acceptance rate of the software.

High user acceptance rate
In LuitBiz QMS, your quality department can design complaint forms based on your SOPs. This ensures that you do not have to change the way you work by switching to LuitBiz QMS from your paper-based quality management system. This makes the transition to a digital system very efficient making users happy as software acceptance rate is very high.



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