13 Common Issues in CSV: Let's Start Solving Them, Part 1 of 3

13 Common Issues in CSV: Let's Start Solving Them, Part 1 of 3


Welcome to 2020, everyone!  As we move into a new decade, Computer Systems Validation continues to be a critical element of the compliance process for life sciences companies.  While the FDA’s compliance regulations have not changed much over the years, technology has – and continues to do so.  As a result, many organizations struggle to reconcile the “old” with the “new” in terms of policies, processes, and tools.

In this blog series, I want to address common issues or perceived roadblocks that we commonly hear as we work with life sciences teams in the world of CSV.  More importantly, I want to illustrate and highlight how companies can address these challenges, or at least start thinking about how to approach them.

Some of these may look familiar to you as something your team has already overcome, but perhaps some of them may resonate because it’s something you are currently struggling with.  Now, of course, we’re just highlighting a summary overview of these items for the sake of this format, but I wanted to get it out there at least as a morsel for something to start thinking about as you evaluate the state of your CSV practices in 2020.

So, let’s begin, shall we?

1: “We have good policies and processes in place for maintaining regulatory compliance, but we lack the proper tools to maximize our operational efficiency.”

In the world of compliance, having solid policy and process governance in place within your
organization is a good start. But with the rapid change in technology, having the right tools is becoming more critical every day.

Document-centric methodologies and tools (both paper and electronic) are quite commonplace in many life sciences companies today.  It is important to note that some tools – including MS Word and Excel spreadsheets – aid in the documentation but not in the management of the underlying CSV compliance process.  Supplementary tools can assist with the process by leveraging templates and electronic documents but are still constrained by the inefficiencies of using documents in an increasingly Agile and DevOps focused world.

Due to industry insights and focused development efforts, newer digital technologies have opened up a whole new, and much improved, approach to compliance: data-driven CSV.  Tools that focus on data permit a broader, more integrated compliance perspective while breaking down the information into more granular elements that leverage the metadata behind it.  Now may be the best time to look at the new tools that are available and make an informed decision of which approach works best for your organization – and fits with your policies and processes.

2: “We realize we need to change our technology to adapt to the changing marketplace, but we’ve learned this type of initiative is cost-prohibitive.”

Investment in new technologies can be a large commitment of dollars, time and resources. However, experience has shown that if this type of project is delayed, the cost of waiting can far exceed the projected dollar spend.  That end result can be a delayed software launch, inability to upgrade to a newer version of software, compliance issues due to outdated technology, FDA fines and more.  It’s the difference between being proactive and reactive.

3: “Upgrading and maintaining validation on existing systems has become so burdensome that we are hesitant to upgrade or introduce new tools or systems into our environment.”

From an upgrade standpoint, the biggest burden often centers
around one factor – cost.  Manually intensive systems are inherently costly in terms of (slow) processes, (energy-draining) resources, and (inefficient) tools.  Today, with the advent of many hybrid configurations, the critical tasks of upgrading systems and maintenance can
appear more complex and cumbersome, but it doesn’t have to be a daunting
exercise.  Stepping back, taking a holistic view of the entire process, and creating an effective validation strategy and plan can help ease that pain.

4: "Our organization lacks a consistent, repeatable validation and record-keeping process across our various teams and locations.  Although it can be difficult and expensive to manage, it does not really expose us to any compliance risk.  Right?"

Wrong.  In any organization, a lack of consistent, repeatable process impacts the total system (people, processes, and tools).  This can lead to confusion, conflicting tasks and inconsistent decision making.  These decisions may even lead users away from corporate policy and SOPs.  These deviations from corporate standards then need to be justified at the time of an audit.

Implementing the correct process, along with the right tool, can provide a repeatable, configurable workflow – assuring consistency while providing the flexibility needed by different business units.

Keep your eyes open next week as we work through more of the 13 common things we here as headaches in the CSV world and hopefully share a bit more on how to start thinking about those issues if they are plaguing your team.

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