13 Common Issues in CSV: Let's Start Solving Them, Part 2 of 3

13 Common Issues in CSV: Let's Start Solving Them, Part 2 of 3

Welcome to part 2.  If you’re just starting here, don’t worry, you don’t have to read part 1 for this to make sense, but I would still recommend going back and reading it so you can take a look at some of the other common issues we discussed.

In any case, let’s resume our journey down the list of 13 common pain points that we hear as we work with various life sciences teams in modernizing their CSV and SDLC practices.

5: “When we evaluate modernizing our regulatory compliance tools and processes, we are met with strong cultural pushback because “what we do works”.

Yes, the old adage of “if it’s not broken, why fix it?” continues to live and breathe in the halls of corporate governance today.  It is natural for people to resist and reject change.  Change means potential risk. Change means potentially failing.  And change can mean job killer.  Why change something that is working just
fine?

The problem with not changing is two-fold (it’s actually more than that, but we'll start with two):

  • The world does not stand still – especially the world of business and technology.  That means your competitors are not standing still either.  They are searching for better, more effective ways to automate processes, speed up production, improve system functionality and reduce cost.
  • Technology is changing rapidly.  This new world of “digital disruption” is creating innovation in areas that people only dreamed of before.  Innovation breeds improved products and services, increased accuracy and oversight and competitive differentiation.  This certainly applies to CSV.

Yes, you could argue that using the same old compliance tools and processes does work, but at what cost?  You can be guaranteed slower production, lower efficiency, minimal veracity and much higher expenditure (in terms of both resources and processes).  Not to mention greater risks of non-compliance and FDA audits (Note: The FDA is not standing still either). 

Take the time to do a thorough evaluation of new technologies and processes and be sure to engage with all the relevant parties in your organization to help provide them with understanding prior to asking for their buy-in.

6: “Due to the somewhat vague and indirectly defined nature of regulatory compliance codes and guidelines, we find ourselves erring on the side of caution and have implemented what are probably overly rigorous validation testing and compliance procedures.  But it keeps us in compliance.”

Sadly, this a natural and common reaction from many life sciences companies.  The FDA issued Title 21 of the Code of Federal Regulation Part 11 (better known as 21 CFR Part 11) back in 1997 to provide criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures on paper.

In the FDA’s effort to permit the widest possible use of electronic technology while being charged to protect the public health, its regulation was complicated, confusing and vague. Industry bewilderment continued after the FDA issues its “Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application” in August 2003.  This document, which was designed to clarify much of the original law, actually contradicted some of its original positions.

Talk to some of the technology compliance firms that deal with these issues daily.  You’ll discover new insights and methods of addressing CFR Part 11 – including what you could be doing, what you should be doing, and what you must be doing.  Erring on the side of caution can make you feel more secure, but in the long run, it can also burden you with time-killing processes, costly investments, and audit prone-mistakes.

7: “Our current waterfall methodology in CSV does not allow us to meet organizational and business demands for more modern development and testing methodologies.”

Traditional document-based CSV is a linear process and lines up well with a waterfall development methodology.  With the ability to now utilize data elements (vs. documents), an increasing number of life sciences companies are taking advantage of an agile methodology.  Managing CSV through individual data components instead of documents really enables companies to more fluidly and seamlessly execute their validation testing activities within the framework of a more iterative based agile approach.

Time does not stand still, and neither should your processes.  The one thing to say about an agile approach is that it moves. How you move is equally important.

8: “We are unable to gauge the progress of individual or multiple projects due to lack of visibility and reporting on the review and approval status of various test stages.”

Transparency is the number one thing that can move your organization forward light years ahead of your peers.  True transparency means having all the data available to all stakeholders and letting the data drive the decisions, rather than using subjective interferences or preferences.  There are a number of tools that enable a data-driven approach to requirements and testing.  In order to fully utilize them, data needs to map to your business processes so you get the correct output for analysis.

I know you are sitting on the edge of your seat with bated breath, waiting to see number 9 and beyond, but you'll just have to hold tight until next week when we post the final piece of this series.

In the meantime, if you have any questions or want to discuss anything you've read through the first two posts in this series in more detail, reach out to us at info@tx3services.com and we'll be in touch.

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