GxP Project Management Made Simple

June 03, 2015 / by Paul Moran

keep it simple in gxp project management

GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.

LIMS software helps pharmaceutical companies ensure that they are meeting GxP compliance guidelines and protects from data integrity issues. However, putting a LIMS software package into place can be time consuming and frustrating if you are not prepared for it. By keeping these three tips in mind from the start of your project, you'll find that it will run smoothly and save you valuable time and resources.

GxP Project Management Tip #1 - "KISS: Keep it Simple and Straightforward"

The KISS principle states that most systems work best if they are kept simple rather than made complicated; therefore simplicity should be a key goal in the design and deployment of software, and unnecessary complexity should be avoided.

“Genius is the ability to reduce the complicated to the simple.” – C. W. Ceran

“If you can’t explain it to a six year old, you don’t understand it yourself.” – Albert Einstein

Too often, people over­complicate things in business because it’s too much effort and hard work to make it simple.

GxP Project Management Tip #2 - "Start With Process Mapping"

Process mapping is one of the quality and process improvement tools used at the start of a Lean Six Sigma project. It is also an excellent tool to use at the start of a LIMS deployment project.

Given the complexities of modern business processes there is a need to capture and visualise knowledge that resides with the people who perform the process steps. This is best captured at the start of a LIMS deployment to help visualise the repetitive administrative steps that can be overcome to free your time for those more important QC laboratory activities. It's at this stage where data integrity steps can be identified.

Process maps do not have to run into many pages, making them difficult to read and understand. As always, keep it simple and focus on the critical few process steps and not the trivial many.

GxP Project Management Tip #3 - "The Most Important Thing In A LIMS Deployment"

The most important thing is to make the most important thing the most important thing.

The highest priority of a LIMS deployment project must be to satisfy the customer through early delivery of software that adds value to their business. Capturing the voice of the customer at the earliest opportunity is so important. The most efficient and effective method of conveying key information within a deployment project is through face-to-face dialogue and driving simplicity – the art of maximizing the amount of work not done!

GxP project management doesn't have to be a harrowing experience. By utilizing the tips above through every stage of your project, you give yourself the best chance of success without wasting time and resources.

creating a culture of quality for data integrity in a business


Topics: LIMS, Data Integrity, Project Management, GxP, audits, comliance, process improvement software, process mapping

Paul Moran

Written by Paul Moran

Dr. Paul Moran is the founder of Broughton Laboratories Ltd and Broughton Software Ltd who serves as their Chief Executive. As a chemistry graduate with a PhD in Biotechnology, Paul began his career at the US pharmaceutical manufacturer Johnson and Johnson. In his role as QC Laboratories Manager, Paul obtained Six Sigma Black Belt certification. Paul entered the world of contract QC testing in 2003 supporting the successful growth of a contract laboratory leading to its merger in 2005. Paul started his first venture in 2006, establishing Broughton Laboratories as one of the leading UK MHRA and US FDA GMP licensed contract laboratories with its own dedicated stability storage facility which opened in 2011. The spin-off company, Broughton Software, was established in 2012 to provide a LIMS solution for regulated QC Laboratories. LabHQ LIMS launched its 4th release in September 2015.