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...

“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...