Whatever your regulatory needs are, we’re here to help.
RMPDC’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 you are compliant with your contract, and all regulations that pertain to the Pharmaceutical industry. We work hard to assure alignment of all of our Quality System documentation.
Using Lean Principles
In a highly competitive industry, RMPDC continually strives for ways in which to improve its service delivery models. Starting in 2004, RMPDC began adopting Lean Principles. This organization-wide initiative has been a key part of our continued process improvement and cost reduction. 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.
Quality Management System
RMPDC has a fully established robust Quality Management System (QMS). We have a quality manual to describe our overall QMS and have both global and client specific SOPs. The objective of the Quality Management System at RMPDC is to implement and maintain a management system that demonstrates the ability of RMPDC to consistently provide the services that meet our client’s 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 RMPDC
RMPDC has been audited on a regular basis by the Food and Drug Administration (FDA) with excellent results. We welcome client audits at RMPDC because these audits assist us in continual improvement of our Quality Management System. Our Internal Audit program, led by Certified Lead QMS Auditors, helps to ensure that we are continually improving our internal processes. We pride ourselves on always being in a state of audit readiness for the FDA, our clients and our internal auditors.
For more on how we can make compliance simple for you as well, contact us.