Lean CSV Requirements and Planning – How to Reduce Waste, Increase Value, and Maintain Compliance

March 5, 2015

The diagram below depicts an example CSV lifecycle alignment with ASTM E2500 and GAMP.

Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on specific lean considerations within the first phase of the Computer System Validation (CSV) lifecycle.

Key Terms:
Lean: a systemic method for the elimination of waste within a process
Value Stream: a technique used to document, analyze and improve the flow of information or materials required to produce a product or service for a customer

Focusing on the eight waste types identified in the prior post (DOWNTIME), this post intends to identify the key lean waste areas and associated corrective action considerations for removing the most waste in your processes and deliverables, yet still maintaining acceptable risk-based compliance. As a reminder, DOWNTIME is an acronym for the following: Defects, Over-production, Waiting, Non-utilized talent, Transport, Inventory, Motion, and Extra processing.

Also, as Six Sigma tells us, it's the 3 P's that matter: People, Process, and Product. Thinking in these terms will help us focus on the aspects of lean that we need to in the areas of the lifecycle that are applicable.

System requirements development and project planning typically go hand in hand, and if not, they should. Below is a table identifying the typical tasks/deliverables (product) expected within this phase of a project and the considerations necessary for reducing waste.

So these are all legitimate considerations, but what are some realistic corrective action implementation practices? Here are some examples:

In summary, if you think of your current processes in terms of the people, process and product factors that contribute to waste, you will be able to better identify and categorize corrective actions that will make your workflows/value streams more efficient and effective.

Remember, continuous improvement is just that, continuous. This means the process of reducing effort, time, cost, and defects needs to be an on-going focus to not only be competitive but produce higher quality products.

Learn more about ProPharma Group's Computer Systems Validation services.
Contact us to get in touch with our subject matter experts for a customized CSV presentation. 


Computer Systems Validation Life Science Consulting

March 5, 2015

Looking to the Cloud for your Business

It’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access the system. Then...

Read More
Compliance Life Science Consulting

March 5, 2015

Value Found in FDA Warning Letter Reviews

Starting with the issuance of a 483, the stepwise FDA enforcement process can be illustrated as follows: Given the seriousness of a Seizure and Injunction scenario, not to mention potential jail time...

Read More
Process Validation Life Science Consulting

March 5, 2015

Which Is Best? Regression versus Control Charting

I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye­: data...

Read More