Publication

Leveraging compliance to accelerate programmes

An article from the September 2006 issue of Impacts

Challenges faced in the pharmaceutical, medical device and diagnostic industries have become increasingly complex. One contributing factor is the continuous evolution of regulatory expectations on operations, information systems, development, and continuous improvement.

Programme portfolio throughput falls behind on expectations when compliance constricts rather than enables programmes.

How can compliance expectations be used to move programmes forward more effectively?

• Understand how compliance and quality affect corporate dynamics. Do Quality Assurance and Regulatory Affairs dictate solutions for improvement programmes? Do QA and RA support and guide their internal customers? How can you steer towards optimal dynamics?
• Turn around critical programmes which do not deliver their full potential. Perform a full, independent diagnosis. Implement a robust approach that leverages familiar approaches where possible, avoids problems and keeps programmes moving through the pipeline.
• Adhering to well defined, robust processes reduces compliance risk and burden. Effective decision making and minimised scope creep reduces programme rework. Reduced rework minimises errors and set-backs. Less error minimises compliance burden and may result in using compliance to accelerate programme delivery.

The article attached is based on PA's current experience in:

• Affecting compliance dynamics to improve results.
• Re-establishing control over your programme: Building the foundation to effective delivery of
  sustainable solutions.
• Compliant product and process development: investing time and energy upfront reduces risk and time during clinical evaluations and regulatory submissions.

This combines into unique expertise in leveraging compliance to accelerate time to benefit.