Blog

Author: Mayra I. Rosa-Pagan, Lead Consultant

After facing notification of the regulatory inspection results, it is important to address the findings with diligence and accuracy to complete the commitments satisfactorily.   Following are five (5) imperatives to manage your remediation plan.

1. Understand the findings

Be certain of understanding the context of all observations and the evidence that was identified during the inspection.

2. Timely response

 Act immediately to begin the investigation and demonstrate diligence to the Agency. There are specified due dates to respond with adequate action plans to correct and prevent the issues identified during the inspection. Commit to act and deliver results.

3. Thorough investigation

 Perform a comprehensive investigation, methods and processes must be evidenced showing that root causes were determined and are being addressed.

4. Comprehensive response content

 Work with your Counsel on the proper documented response. Primary a...

Author: Mayra I. Rosa-Pagan, Lead Consultant

Within the Quality Management System there are several important elements to demonstrate the effectiveness implementation towards customer satisfaction. Also, there are fundamental requirements to show compliance to regulatory requirements at all times. Following are the of the most common problems we faced in the QMS and several proposed solutions to help on tackling those down.

1. CAPA

Inadequate CAPA records are a symptom of inefficient quality controls and the preamble of regulatory compliance issues.

Solutions to avoid compliance concerns you must:

1. Establish a well-defined procedure for root cause investigations and analysis.
2. Implement a CAPA Review Board that will have responsibility to oversee the CAPA process and well-documented records from issuance, progress up to the closure of effectively implemented corrective actions.
3. Promote preventive actions to avoid quality issues to occur and foster continuous improvement p
...

“Quality System Audit is your basic Compliance Assurance mechanism”

- Mayra I. Rosa-Pagán, Lead Consultant

An effective Quality Management System must have a solid Auditing Program that assures you the upmost compliance standing. However, good quality audits are obtained through a process approach methodology that could reveal the efficiency of your systems, processes and operational activities. 

What are the core 4 elements for process approach audits?

Process approach refers to the audit cycle and it is what I call: the “PERC” process.

Plan (P)

Planning the audit requires understanding the regulatory requirements, developing the auditing strategy, reviewing all required documentation and notifying the organization to begin the audit.

Execute (E)

Execution will start with an opening meeting, implementing auditing techniques to gather objective evidence and reporting progress according to audit plan.

Report (R)

Reporting consists on preparing the final document that details a...

“Quality is not an act, it is a Habit.” - Aristotle

Author: Mayra I. Rosa-Pagán, Lead Consultant

One of the pillars for an effective Quality Management System is to have implemented a robust Corrective and Preventive Action program, which we normally call it “the CAPA system”.

The CAPA system is not only considered the heart of well-efficient management system but it also provides enormous inputs to the continuous improvement efforts towards Quality. 

What are the fundamentals for a robust CAPA System?

1. Well-defined investigation procedure

Your procedure on how to conduct effective investigations is a basic requirement for the solid results and clear action plans needed within your CAPA System.

2. Data trending for prompt detection of potential issues

Have a comprehensive mechanism to collect data and perform periodic data and trend analyses. It will show you the current issues but most important is to identify potential problems that you can prevent.

3. Effective implementa...