The Role of Management Review in Regulatory Compliance

A leading global pharmaceutical company, with operations across North America, Europe, and Asia Pacific, faced a major challenge: an overwhelming number of complaints. Concerned, the company's founder engaged the Director of Quality Management to address this issue.

In response, the Quality Director swiftly initiated and executed a plan to digitally transform their complaint-handling process. This was crucial because the volume of complaints was also hampering regulatory approvals.

We know this story first-hand because the company decided to implement ComplianceQuest EQMS as part of its digital transformation initiative. This implementation not only streamlined their complaint management but also enhanced regulatory compliance and quality control across the board.

Recently, we asked the Director of Quality, why she chose ComplianceQuest, and this was her response:

“We were very familiar with the Salesforce Platform, and the fact that ComplianceQuest is built on Salesforce and will seamlessly integrate with our ERP and CRM was really helpful. But, beyond that, we liked CQ for the following reasons as well: predictive analytics capabilities; the management review module that helped the leadership and quality teams collaborate better; and the user-friendly interface.”

For the company, one of the biggest challenges was to enhance collaboration between the executive team and the on-ground quality professionals. The Management Review Solution as part of ComplianceQuest EQMS was a game-changer in this regard. “All our review meetings revolved around analyzing real-time data and using insights from this to plan out our strategy.” Just implementing a complaint-handling solution (in a silo) wouldn’t have been as effective.

We narrate this customer story here for a reason; This post is about the role of the management review process in the journey towards quality excellence. Of course, having the ability to involve various stakeholders - including the management team - is key from a compliance perspective as well.

Data-Driven Management Review Meetings for Better Quality and Compliance

At ComplianceQuest, we published a whitepaper titled “Derive Maximum Value from your Management Reviews with AI, Automation & Analytics”.

In this paper, we touched upon what executive leadership teams may look for in a management review solution, as part of an EQMS Solution Suite. Overall, it was clear that management-level decision-makers wanted to:

• Have a finger on the pulse of all quality metrics, open action items, quality goals, etc.
• Drill down a few levels to see location, product, or customer-specific quality metrics.
• Collaborate and engage more with the on-ground operations team to take the necessary actions without wasting time.

Simply put, they wanted to run a management review process with data and metrics at the core. They wanted to take advantage of AI and automation capabilities so as not to waste time on mundane tasks, and instead use the time meaningfully to make critical decisions around better quality & better compliance.

ComplianceQuest’s Quality Control Tower

One of the most sought-after features in the Management Review module was having a modern control tower - one that would make it extremely easy for leaders to track data, check progress on action plans, monitor outcomes, and brainstorm “next steps”.

A modern Quality Control Tower, such as the one from ComplianceQuest, enables organizational leaders to react to and correct issues as they arise, thanks to the following key capabilities:

• Real-time data visibility from across the value chain with dashboards, notifications, and integration of multiple business systems.
• Analytics gathered through root-cause analysis, simulations, what-if scenario analysis, risk analysis, and response management.
• The dissemination of information to relevant stakeholders and action plans.
• Monitoring of outcomes.
• Business leaders or operational owners can also drill down further on certain operational metrics to deep dive and analyze a particular KPI as needed.

With CQ Management Review Solution, we ensure companies have comprehensive control over how management reviews are conducted to not only meet regulatory requirements but also ensure all key stakeholders collaborate to improve overall performance in terms of quality, safety, and compliance.

Ideally, a management review of the quality system must be conducted every quarter.

A good review process will include the following steps:

• Well-planned agenda
• Pre-planned list of attendees
• Set of metrics to be analyzed
• Clearly documented meeting minutes and follow-up actions to be taken
• Data-driven process to analyze risks and opportunities, regulatory reporting, etc.

With the CQ Management Review Solution, this entire process becomes collaborative and streamlined. It is also designed to meet ISO, FDA, and other regulatory requirements with ease.

To learn more, request a demo: www.compliancequest.com/online-demo