Software Validation in Pharma: Top 5 Challenges

  • Published:
    Jan 24, 2023
  • Category:
    White Paper
  • Topic:
    Security & Compliance

Executive Summary

Software validation is crucial, especially in heavily regulated industries such as pharmaceutical manufacturing. But that doesn’t mean it’s easy. Or fast.

Advanced digital solutions have the potential to make software validation easier and more efficient, especially so in the ever-evolving world of pharmaceutical manufacturing.

However, many pharma organizations are still hesitant to make the switch. In fact, only 37% of life science companies are currently implementing digital technologies.

This begs the question: Why are pharmaceutical companies resisting this change? 

In this article, we’ll unpack our answer to this question in depth. To do so, we’ll examine software validation in the context of pharma’s top priorities, perspectives, and pain points to this process.

We’ll start with an overview of software validation and how it’s used in pharma. We’ll then walk through some of the top challenges pharmaceutical manufacturers face with traditional approaches.

Last, we’ll consider incremental ways organizations can address these top challenges and resolve them head-on.

Jump to…

GxP Software Validation: An Overview

We’ll start off by defining what software validation is and why it’s so crucial in pharma. Then we’ll outline specific challenges pharmaceutical organizations can face when validating their systems and processes.

What is software validation?

Software validation is the process of verifying that systems are “validated” by an overseeing entity — in other words, that they are correctly set up and ready for use.

This process includes ensuring that the solution will meet the user’s specific requirements and function as intended.

What is software validation in pharma?

Software validation in pharma is when a regulated organization authenticates that its software and systems can accurately and consistently produce results that are aligned with pharmaceutical compliance and quality management standards.

Why is software validation necessary in pharma? 

Software validation is a key component of pharmaceutical manufacturing. It verifies systems are set up correctly so that production can be streamlined, and drugs are safely manufactured.

However, many organizations can feel overwhelmed by the prospect of validating their systems and processes because there are so many moving parts.

Next, let’s take a closer look at these difficulties and concerns.

Software Validation: Why Is It So Complex in Pharma?

Software validation is undeniably critical to pharmaceutical manufacturing. So then why isn’t there a tried-and-true method for getting it done quickly and easily?

Unfortunately, just because something’s necessary doesn’t mean it can be achieved easily, or painlessly. (Looking at you, DMV.)

To answer this question, we’ll look at it from a few different angles. Read on to dive into some of pharma’s top pain points and concerns with the software validation process.

How is software validation perceived in pharma?

In the pharmaceutical industry, software validation can be viewed as a source of red tape, lengthening timelines by adding extra steps and variables to already complex processes.

And it’s true that software validation can be considered an inhibitor in pharma manufacturing. However, it’s a crucial step with far-reaching impacts.

Without proper validation, avoidable mistakes that impact the quality, safety, and efficacy of therapeutic products are likely to occur. And that’s why it’s so crucial to use the right approach; one that’s by progress, not paperwork.

“Validation needs to come from a place of innovation and enablement — not bureaucracy.”

— Michael Martone, Director, Quality Systems, Apprentice

Does the FDA provide software validation?

Although the Food and Drug Administration (FDA) offers helpful validation guidelines, it doesn’t supply a solution to achieve the end goal, nor does it provide a step-by-step “how to” instructional.

Does the FDA’s validation guidance change?

The FDA regularly updates their guidance on software validation so they can stay on top of new technologies and software capabilities.

Since technologies, mindsets, and regulations are always changing, the FDA’s validation guidance will always be in flux as well. And that’s why it’s crucial to handle this process with caution.

To illustrate this, let’s explore the FDA’s most recent validation update from CSV to CSA.

What’s an example of evolving validation guidance?

In the fall of 2022, the FDA released new draft validation guidance.

This guidance called for a shift from the previous Computer Systems Validation (CSV) method, which often led to overdocumentation.

In its place: CSA, or Computer Software Assurance. CSA leverages critical thinking to ease the documentation burden of the CSV approach.

In this shift to CSA, critical thinking will now play a much bigger role than before in validation efforts.

By prioritizing this method of rigorous and ongoing data evaluation, the FDA intends to uphold the same level of compliance while also reducing the validation effort.

Top 5 Software Validation Challenges for Pharma

There are various challenges that may negatively impact the software validation process. To deftly overcome these issues, awareness and action are key.

Here are five of the top challenges to software validation in pharma:

  1. It’s resource intensive. No matter how you slice it, validation is a complex and expensive process. But it’s necessary to ensure the safety and efficacy of products entering the market. To minimize resource waste, and prevent unnecessary errors, pharma companies should partner with a vendor that follows GAMP 5 practices and verifies governance procedures are in place.
  2. It takes time — lots of time. The complexity of validation processes can add delays, lengthening timelines and adding extra steps and variables to already complex processes. In addition, the need for back-and-forth communication between distributed teams and organizations layers on additional time for correspondence.
  3. It creates internal burdens. Quality, Compliance, and Information technology (IT) departments already have their hands full when it comes to pharma manufacturing. This team is responsible for improving compliance, data integrity, and product quality. Adding validation to the mix creates another layer of pressure, and may result in production delays. Instead of placing the responsibility solely on a single department, it’s better to involve a neutral vendor that can review and approve documentation.
  4. Regulations vary worldwide. Depending on the jurisdiction a pharma organization manufactures within and sells to, the regulations vary. But the bottom line is that every government puts safety at the forefront of its regulations. To maintain compliance, pharma companies can leverage a validation system purpose-built for life sciences that bakes GxP disciplines into its system.
  5. Guidance changes routinely. As we’ve seen in the FDA example above, regulatory guidance around validation doesn’t stay the same over time. In order to adapt to present-day demands and technologies, the FDA monitors new advancements and updates their guidelines accordingly.

Think of it as a Soccer Match… but Harder

Still reading? We’re flattered! We’ll reward you with an analogy that makes it easier (for us, anyway) to imagine the weight and impact of these challenges.

Let’s consider the software validation process as a multiplayer game, such as soccer.

Hang on, that doesn’t sound too bad. Who doesn’t like soccer? Well, would you still like the sport if your target kept on changing?

Because that’s the game of pharmaceutical software regulation.

Think of it like a soccer match, except the goalposts keep on shifting:

Take the validation shift from CSV to CSA that we covered earlier. While this is a pivotal update, it is by no means the last time this type of high-impact change will occur.

So how can you stay up to date? What’s your move?

As we’ve covered above, there are multiple ways to play the game. And ultimately, the choice is yours.

At the end of the day, it will all come down to finding the right fit — a match to your organization’s process, goals, and priorities.

So how do you find that ideal match? As a first step, you can host a goal-setting session to uncover and crystallize your team’s top needs and challenges to software validation. Then, loop in stakeholders across the organization to get a wider perspective and ensure alignment across functions. Next, rinse and repeat until you’ve got a core list of objectives in place.

Modern Solutions to Software Validation

Here at Apprentice, we’re proud to say that when it comes to software validation, we’re all in on the game.

Sure, it’s complex and granular and infinitely nuanced — but that’s what makes it so much fun to win, and to help our customers win too.

Software validation is no joke — the process is not only time consuming, but it’s also crucial to ensure regulatory compliance. That’s why our software and processes have been purpose-built around pharma’s specific needs and stringent security requirements.

So what does that mean for you? In short, you’ll get time back in your day.

We’re on top of these sorts of regulatory update requirements, so you don’t have to be. Let us spearhead your validation efforts so you can focus on hitting all your other manufacturing goals.

Don’t settle for some general-purpose manufacturing software that’s been retrofitted to apply to the pharma environment. Rest easy by choosing a system that’s secure, compliant, and tailored to your needs.

Want to learn more about Tempo’s software validation process? Book a call with a member of our team to find out more.

Closing Thoughts

At an organizational level, change management can feel daunting. Updating processes takes time, is often uncomfortable, and involves many moving parts.

And to top it all off, people avoid change like the plague.

Why learn something new when you can keep doing things the same way they’ve always been done? How can you shift the focus to long-term ROI, when the short-term transition can be such a pain?

But with the right solution in place, it can make life easier, and ultimately the pros (including the time and cost savings) can considerably outweigh the cons.

It’s hard to put a price on peace of mind. How much is that worth to you?

You can either keep one eye fixed on those shifting goalposts… or you can pick a trusted validation partner to help you score that crucial goal.

Someone who’s already got both eyes glued to the goalposts. Who already knows the players, the score, and the field inside and out.

Best of all, someone who knows where the ball needs to go next — and has a tried-and-true plan for getting it there.

Our Featured Thought Leader

Michael Martone is committed to quality. As Director of Quality Systems at Apprentice, he keeps Quality priorities top of mind and on target for our teams and our clients.

Read on to learn more about Michael’s background and industry insights on pharmaceutical software validation.

Michael’s Background

Michael Martone brings over a decade of experience to his tenure at Apprentice. Michael covers a wide range of process areas in his work, providing guidance on Quality as well as Compliance and Validation.

Michael’s experience spans a number of industries, including Life Science, Medical Device, Aerospace, and Defense. He provides consulting across the U.S. and has implemented Management Systems for adherence to ISO9001, ISO13485, ISO27001, ISO17025, ISO62304, and SOC2.

Ultimately, Michael’s career mission comes down to a single goal: educating organizations on the crucial roles played by Quality, Compliance, and Validation. In this way, he continually demonstrates the value of Quality as a critical source of organizational enablement.


Software Validation: Michael’s Top Take

“In my opinion, leveraging existing information is the key to optimizing validation. Redundancy has been prevalent for far too long and it’s time for efficiency to have its time.”

— Michael Martone, Director, Quality Systems, Apprentice


  1. Center for Devices and Radiological Health. (2022, September 13). Computer Software Assurance for Production and Quality System Software. U.S. Food and Drug Administration.
  2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. (2002). Food and Drug Administration.
  3. Lewis, J. (2022, April 25). Computer Software Assurance (CSA): The FDA’s New Approach to CSV. Kalleid.
  4. Muscat, N. (2022, February 23). Overcoming Pitfalls and Challenges with Software Validation. Certara.
  5. Somich, B. (2022, August 23). The future of software validation in pharmaceutical, life sciences & medical device manufacturing organizations. HSO.