Ensuring Regulatory Compliance

Ensuring Regulatory Compliance

Whatever your regulatory needs are, we’re here to help.

RMPDS’s Quality Assurance department works closely with all clients to develop the necessary documentation to ensure regulatory compliance. We will help you write Standard Operating Procedures (SOPs) and other documentation to ensure that we are compliant with all pertinent regulations − be they FDA, EPA or other. We work hard to assure alignment and smooth integration of all of our Quality System documentation.

Using Lean Principles

In a highly competitive industry, RMPDS continually strives for ways to improve our service delivery models. Starting in 2004, RMPDS began adopting Lean Principles. This organization-wide initiative is a key part of our continued process improvement and cost reduction efforts. We are constantly reviewing our operations to uncover ways in which we can optimize efficiency and eliminate waste, creating better value for our clients. We also practice Lean Principles in coordination with our clients, focusing on their specific processes for improvement.

Our Quality Management System

RMPDS has a fully established and robust Quality Management System (QMS). We have a quality manual to describe our overall QMS and both global and client specific SOPs. The objective of RMPDS’s QMS is to implement and maintain a management system that consistently provides services meeting our clients’ needs and to be compliant with any applicable regulatory requirements. Some of the core elements of our QMS include:

  • Corrective and Preventive Action (CAPA)
  • Document Control
  • Internal Audit Program
  • Management Review

Audits at RMPDS – Practice, Practice, Practice

RMPDS is audited on a regular basis by the US Food and Drug Administration (FDA) with excellent results. We welcome client audits at RMPDS because these assist us in the improvement of our Quality Management System. And then we have our Internal Audit program, led by Certified Lead QMS Auditors, to ensure that we are continually improving internal processes. We pride ourselves on always being in a state of audit readiness for the FDA, our clients and our internal auditors.

Contact us to find out how we can make regulatory compliance simple for you.