FDA Compliance

The Medical Device Industry:

The medical device industry is constantly pushing the boundary of innovation with new product development.  Additionally, the industry is consistently being challenged to meet the rising standards of quality and achieve compliance with rigorous regulatory requirements.

Traditionally, homegrown systems, stand-alone applications, or spreadsheet based systems have been used to manage quality and compliance at the departmental level. Such point solutions lack a broad enterprise reach. Thus, they significantly raise the cost of compliance and increase the risk of noncompliance with FDA's regulations.

The IQS Solution:

IQS offers companies the capability to take a risk-based approach to quality and compliance management. The IQS Solution provides a common integrated approach to meet FDA regulations through risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions.

The IQS Solution provides a comprehensive suite of FDA regulatory compliance software for automating GXP compliance processes, and it offers embedded best practices that ensure ongoing compliance with FDA regulations. By improving operational efficiencies in quality systems, the IQS Solution lowers the cost of regulatory compliance and creates an environment that proactively identifies, tracks and resolves quality issues.

The IQS FDA Compliance Software Solution is widely being used in the life science industry for supporting key processes and requirements for 21 CFR Part 11, Part 210-211, Part 820.

Integrated Quality Hub:

Ensure that all quality related activities are integrated securely to create a single repository for quality related issues and data.

IQS tracks all events as they move from one stage to the next, across departments, groups, customers and suppliers' customers to ensure a closed loop quality management process. For instance, a document change can initiate a training request. Validation that related training has been completed and nonconformance has been triggered as a result of audit findings are then tied back to the audit to ensure compliance.
Corrective Actions/Problem Solving:

IQS provides an analysis of nonconformance trends triggering a Corrective Action. It performs root cause analysis and assigns follow up actions, all the while effectively tracking and routing activities from initiation to closure. It then validates effectiveness of the corrective action to eliminate the reported issue.