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5 CQV Considerations for Integrating New Tech Into Your Facilities

5 CQV Considerations for Integrating New Tech Into Your Facilities

The push towards Pharma 4.0 has generated an ocean of new and exciting opportunities for companies to increase efficiency and boost innovation.

Thomas W. Flanagan

While many companies are eager to reach Pharma 4.0, adopting and integrating new technologies into existing and sometimes aging facilities does not come without its challenges. However, that does not mean bringing your facility into the future is impossible.

With a systematic and thoughtful approach, companies looking to implement new technologies can achieve success. Here are five CQV considerations to make:

1. What New Technology Are You Looking To Implement?

Companies striving for Pharma 4.0 may be overwhelmed by all the new technologies available. Deciding what you are implementing into your existing facility will inform the rest of your decisions, which is why it’s an essential first step.

To begin, determine what point in the product lifecycle you’d like to enhance: R&D, manufacturing, testing, filling, packaging, or any other area. Then, figure out your goals. What are you trying to accomplish? What are the current issues you’re facing that you want to ease?

Asking yourself these questions will help you and your team select the solution best suited for your needs. We Suggest conducting a gap analysis or feasibility study as part of this process. This approach ensures the selected technology addresses the identified needs effectively and integrates well with existing systems.

2. Will It Affect Facility Design?

Assessing the impact of new technology on an existing facility’s design is of the utmost importance. Evaluate the facility and the requirements of installing this new technology and see where they intersect.

Will you need to make updates? Is your space large enough? Are there any safety concerns? Are there aspects of your facility that may not support the new technology? Addressing these questions together with cross-functional teams, like QA, engineering, and operations, is vital to successful implementation and mitigating risk.

3. Will It Impact Your Workforce?

It’s important to consider how integrating new technology will affect your already existing workforce. Depending on the situation, hiring new professionals who possess in-depth knowledge and experience with the new tech may be necessary. Some companies also choose to utilize CQV staff augmentation.

What sort of training does your employees need? Do you need to promote some positions or make some roles obsolete to make room for automation? What is your communication strategy and which support systems do you need to help employees adapt to the new technologies and processes?

4. Is Revalidation Necessary?

Depending on which technology you’re implementing, you should take stock early in the project and determine whether the process will require revalidation or not. If revalidation is necessary, you may want to consider where this technology aligns with your business objectives – as well as what types of validation are required (IQ, OQ, PQ) and the guidelines governing these processes.

What’s the financial cost of revalidation? What will the return on investment (ROI) look like? Do you have the necessary validation equipment? Ensure that your decisions align with your goals and vision.

5. What Are the Security Risks and How Can You Overcome Them?

Implementing new technology often comes with unique risks pertaining to security. Taking this into account from the get-go and employing preventative measures such as installing a firewall will help you protect your data from cyberhackers, data breaches, and ransomware.

Also, if your company doesn’t already have a sophisticated IT infrastructure, you may need to update or install servers, network connections, and controllers. The same goes for your suppliers of monitoring and validation systems, they need to provide a setup that protects your data and ensures its reliability.

Looking to bring your current facility into the future?

Our teams of experts are ready to help your company find the perfect solution and methodology to achieve CQV success before, during, and after the transition.

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