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

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

Here we are.  The final part of this 3 part blog series cataloging some of the more common headaches we hear from customers as we engage with them on getting over some of the roadblocks typically associated with Computer System Validation.

Rather than a long preamble before we get into the final 5 items in our list of 13, let’s just jump right into it (although, if you haven't already, I will encourage you to go back and read the first two posts in this series covering the first eight issues after you read this one). 

9: “We don’t have a clear enough understanding of 21 CFR Part 11 to commit to moving to an electronic process.”

It is important to have the staffing resources and experience – either in-house or with an outside firm – to help you understand the regulation and how it impacts your process within your organization. Remember that the law was written for a host of companies that fall under the “life sciences” umbrella – this includes pharma groups, medical device firms and more.  It is difficult for one well-meaning regulation to fit precisely with the operations of those different entities.

Having a flexible, yet automated process is critical to enable you to leverage technology while adhering to the regulations.

10: “Tool evaluation, installation and support is a constant point of frustration.  While software vendors understand their products, they do no understand the unique context in which we have to implement and use them.”

You should expect software vendors to be very knowledgeable about their products, including the benefits, the features, and all the bells and whistles.  But it is also imperative that you are able to engage with resources (inside or outside your company) that have the experience and understanding of the entire compliance process.

This cannot be overemphasized.  Every company is different – different processes, different procedures, different cultures, and different technologies.  You want to make sure you can connect all the parts, so your compliance process is comprehensive, completely integrated and audit-proof (to the best of your ability).  And that means connecting all the key team players who can oversee and manage the compliance operation, especially those who can couple expertise in the solutions and tools with an understanding of deploying and utilizing them in a regulated environment.

11: “Much of our time is wasted by repeating manual testing, and manually executing review and approval tasks that could probably be handled more effectively through automation and electronic approval capabilities.”

The days of manual tasks are (almost) gone.  Digital technologies have helped to automate a host of activities that used to tie up resources, slow production and drain money. For example, automated testing tools are now used regularly for the validation and verification of embedded software in the design and development process for many organizations.  And for larger enterprise applications, automated CSV tools aid with important mechanisms such as enterprise resource planning, document management systems, laboratory information management systems, and more.

12: “We rely on our various teams and personnel to adhere to our outlined processes and SOP’s, but we don’t have any way to implement governance over our workflows to ensure they are being followed and executed to our defined standards.”

The keyword here is “governance”.  Governance should be established over all teams and personnel – how they work together, the process they follow, and the tasks they are responsible for.  Governance needs to be established over all workflows – to ensure tasks are being completed, forms are being signed, and proper controls are put in place to mitigate deviation.  Governance should also be established over all data – how it is being used, how it is being managed and how it is being protected.

The entire compliance operation should be transparent so that anyone can identify which steps are currently underway, uncover any bottlenecks, and address any issues or challenges in the process.

13: “Preparation and completion of audits are stressful, disorganized and overly time consuming.  There has to be a better way to address this.”

This is an issue that pops up with many organizations that are traditionally under-staffed or have lacked governance across teams and tools for several years.  Without proper checks and balances in place, any activity that disrupts your day-to-day operations will seem onerous.  It’s kind of like having to do your taxes.  If you do monthly budgeting and accounting tasks, taxes are relatively easy.

Creating – and maintaining – an active governance plan can help alleviate this experience substantially.  Providing oversight and keeping control of the smaller details will make sure they do not turn into one huge headache when the time comes. There are tools that can do this for you!

I know this series was a fairly brief summary of some headaches and similarly brief responses in ways to think about or address those headaches, but these are all things we deal with and work with day in and day out.  If you would like to discuss any of this in more detail, please feel free to reach out and we will be happy to have a conversation with you and/or your team.

Contact us at info@tx3services.com and someone will be in touch shortly.  Just reference that you read this blog series!

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