As the pharmaceutical industry faces new challenges, many companies are actively looking for opportunities to improve their current processes and find new areas for innovation.

These efforts contribute toward a larger shift within the industry—the shift to Pharma 4.0.

The goal of Pharma 4.0 is to increase efficiency while also ensuring compliance and quality are inherent aspects of all processes and systems.

Because these efforts often include introducing new technologies, more digitization, and more automation, a crucial element of reaching Pharma 4.0 is a holistic control strategy.

What is a Holistic Control Strategy?

While a control strategy is a plan that outlines the controls a company uses to ensure performance and product quality and safety, a holistic control strategy takes it a step further.

A holistic control strategy is an all-encompassing, integrated approach that addresses every event that occurs through a product’s lifecycle. It considers all stakeholders involved, including regulators, manufacturers, standard-setting organizations, supply chain personnel, and patients.

This approach harnesses the power of enhanced digitalization efforts and uses real-time, transparent data to help organizations make more informed decisions regarding all aspects of a product’s lifecycle.

Creating a Holistic Control Strategy

Because holistic control strategies leverage data made possible by digitization efforts, an organization must first achieve the proper digital maturity level before designing and implementing one.

According to the ISPE, the steps toward creating a holistic control strategy tie directly into the four areas of the Pharma 4.0 Model: resources, organization and processes, information systems, and culture.

Use the following tips to help your organization create a holistic control strategy that aligns with each element of the Pharma 4.0 model.

1. Create multidisciplinary teams.

Organizations need to create teams comprised of experts from various fields to build their holistic control strategy framework. Having experts from different backgrounds work together is vital as they can each provide a different look into the same processes to identify potential issues and risks. Make sure to create and carve out defined roles for each team and team member early on.

2. Prioritize integration and elimination of silos.

When it comes to organization and processes, it’s crucial that an organization eliminates information silos and have a high level of process integration. As previously mentioned, holistic control strategies require a higher level of digital maturity. If your organization is at a digital maturity level of one and is still largely paper-based, you won’t have access to the high-quality data needed to drive a holistic control strategy.

3. Design information systems to facilitate digitization.

It’s essential that all IT stakeholders map out how they will manage data and identify potential risks in the beginning stages of holistic control strategy development. Then, organizations should design their information systems to align with any new or existing digitization requirements and processes.

This approach helps organizations ensure that the right data is available at the right time to help stakeholders make quick, informed decisions and ultimately drive more efficiency, productivity, and automation.

4. Promote transparency and trust.

Lastly, a holistic control strategy cannot thrive without the proper cultural environment within the workplace. High levels of transparency and trust are key. Organizations should not only dismantle information silos but silos that exist between internal teams. Senior leadership must drive these changes.

Designing Your Holistic Control Strategy

Implementing a holistic control strategy helps biopharma companies ensure compliance and quality while introducing more digitization and automation into their processes.

A holistic control strategy isn’t a one-size-fits-all undertaking, so knowing exactly how to design and execute such an in-depth strategy can feel daunting; however, the benefits are vast.

Our commissioning, qualification, and validation team is ready to help you create a holistic control strategy tailored to your unique goals and processes.

Get Help From CQV Experts