Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Larry Ferrere, Senior Vice President, Product Strategy & Chief Marketing Officer, Pilgrim Quality Solutions

It’s time to make the move to the cloud. Most businesses are taking advantage of cloud-based applications, private clouds, or cloud data storage on some level. In recent years, the cloud has surged in popularity, and many business are making the move. Early adapters and small businesses view the cloud as a way to reduce IT infrastructure and resource costs, and also as a way of gaining access to technologies that might normally be reserved for larger companies.

Today, businesses are realizing increased benefits from cloud-based technologies beyond just cost savings. For the Pharmaceutical industry, many of the challenges that quality and compliance teams currently face can be simplified by deploying a quality system in the cloud. Let’s take a look at how a cloud-based quality system can propel your compliance efforts to the next level.

Pharmaceutical Quality Extends Beyond Your Four Walls

Every quality professional is aware that quality now extends beyond the four walls of your organization. This includes suppliers, field employees, regulatory bodies, and other members of your extended demand chain.

The cloud simplifies communication, collaboration, and access to quality system processes and data for every member of this chain. Whether you’re responding to a supplier on the other side of the globe, fielding a patient complaint, or submitting reports to a regulatory body, a cloud-based quality system ensures that every member of the demand chain has secure access to exactly the information they need.

 

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Quality in the Cloud Can Keep You Structured

Structured quality data is the key to keeping pace with the next generation of compliance requirements. The FDA’s latest initiatives are designed with quality system data in mind. The CDER Quality Metrics initiative, for example will require that you have a handle on metrics such as Lot Acceptance Rate (LAR), Invalidated Out-of-Specification Rate (IOOSR), and Product Quality Complaint Rate (PQCR). Calculating these metrics will require structured quality system data across your products, processes, sites, and divisions.

Maintaining structured data can be challenging for Pharmaceutical organizations, especially in the face of managing numerous sites around the globe as well as frequent acquisitions. Cloud-based quality systems can provide a stable, structured foundation for scaling the quality system and adding new users and sites quickly. Rather than creating siloed systems at individual sites, the entire organization realizes the benefits of a single quality system in the cloud.

This same concept extends to harmonization, another key quality and compliance challenge. Increasing harmonization drives consistent processes that make it easier to collaborate across multiple sites and throughout the demand chain. This makes your Quality team more efficient and ultimately drives speed to market.

The Cloud Simplifies Compliance

Moving your quality system to the cloud simplifies compliance on a number of levels. Managing the extended demand chain as well a properly structuring your quality system data will become keys to compliance, and the cloud can enable these. In addition to providing extended reach and scalability, many cloud-based quality vendors also provide the mechanism to automate regulatory submissions, such as electronic medical device reporting (EMDR) through the cloud.

Cloud-based quality systems also ease your team’s validation burden. The Installation Qualification (IQ) and Operational Qualification (OQ) are performed by the cloud vendor, which simplifies the process of deploying new applications.

But is it Safe?

The key Life Science industry objection to the cloud in the past has been security. But consider that your quality system may be safer in the cloud than anywhere else. Cloud data and the data centers that support them are typically secured by numerous layer of security from locked cages to biometrics. Many Pilgrim cloud customers agree that they couldn’t possibly provide the layers of protection that cloud services providers have to offer.

Learn More

If you’re curious about Pharma in the cloud, join PwC, Concerto Cloud, Cardinal Health, and Pilgrim’s Regulatory and Product Management Leader, Kari Miller, for our upcoming webinar to learn more. We’ll discuss the drivers that are moving quality to the cloud, describe the benefits of the cloud, and provide examples from a Pilgrim customer’s perspective of their success in the Pilgrim Cloud.

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.

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