Catalent is a leading contract development and manufacturing organization (CDMO), serving global pharma, biotech, and consumer health brands. It manufactures billions of doses of life-enhancing and life-saving treatments for patients every year.

See how Catalent gave teams quick access to controlled documents in the cloud.

Manufacturing sites:

40+
Employees:

16,900
Revenue:

$4.38 billion in 2024

Summary

Challenges

Paper-based processes and disparate document management systems made it difficult to scale as operations expanded.
Needed an efficient way to digitize, consolidate, and access documents.

Solution

Selected a flexible, pre-validated industry solution.
Enabled secure mobile access to key content.
Selected a managed private cloud environment.
Ensured smooth deployment with expert support.

Results

Unlocked scale and innovation with cloud services
Reduced paper usage by up to 30%
Streamlined processes with standardized workflows

Challenges

Laborious, error-prone change management processes for controlled documents
Disparate systems increased the cost and complexity of document management
Reliance on paper-intensive processes was cumbersome and time-consuming
Limited scalability hindered business growth goals

Catalent’s mission is to develop, manufacture, and supply medical treatments that help people live better and healthier lives. At any given time, the company has over 1,000 products in development at dozens of sites all over the world. It must walk the tightrope of getting products to market quickly while maintaining the highest levels of accuracy, quality, and control in manufacturing.

However, maintaining that balance was becoming increasingly difficult. For years, Catalent had relied on multiple document management solutions and paper-intensive processes, which were proving difficult to scale up as operations expanded.

Lindsay Fernandez, vice president of enterprise applications at Catalent, gave an example, “Whenever we manufacture a new batch of drugs, our operators must complete a batch record. Previously, this involved printing a 150-page document and lugging it from workstation to workstation to fill out information on the ingredients used and process steps. Further down the line, quality assurance teams had to read through these documents to make sure proper procedures were followed during manufacturing.”

Catalent was determined to transform content management into a better enabler of operational agility and accuracy. That meant doing away with disparate systems and paper-heavy processes in favor of a more unified and digitized approach.

Our experience with OpenText Professional Services has been top notch. They've helped us through the journey of going from multiple legacy systems to a market-proven industry solution that meets large enterprise needs.

Lindsay Fernandez
Vice President of Enterprise Applications, Catalent

Solution

Catalent uses an OpenText-hosted, cloud-based solution so their quality teams can have quick access to controlled documents for following manufacturing processes and efficiently manage documents through auditable change management and approval cycles.

Products deployed

OpenText™ Documentum™ Content Management for Life Sciences

Ensure GxP-compliant content management in life sciences

Services provided

OpenText™ Professional Services

Get a trusted partner to guide your information management path

Selecting a pre-validated industry solution with flexibility

After launching the search for an industry-specific content management solution flexible enough to support their requirements, Catalent opted for OpenText Documentum Content Management (CM) for Life Sciences.

“One of the deciding factors for us was that OpenText had a solution that was specifically designed for our industry,” said Fernandez. “OpenText Documentum CM for Life Sciences was pre-validated to meet industry standards, and we appreciated its strong controls around audit trails and document lifecycle management.”

Fernandez noted, “OpenText Documentum CM for Life Sciences is now a cornerstone of operations at Catalent. It’s where we store our bills of material, batch records, standard operating procedures [SOPs], and more. It’s the single source that we refer to when we need to manufacture a product, change a process, review procedures, or demonstrate compliance.”

Enabling mobile access to key content

Catalent also makes use of the OpenText™ Life Sciences Smart View extension to provide secure document access and management capabilities on mobile devices. It means employees are no longer limited to workstations when they need to access, review, or share documents.

Fernandez said, “Mobile access is making life much easier for our teams. Now, all people have to do is tap on a tablet device or fire up a laptop. There, they have access to all the data required to verify a process or review a change in operating procedure.”

Saving time with managed cloud services

As part of its move, Catalent opted for OpenText-hosted, cloud-based OpenText Documentum Content Management for Life Sciences. This allows the company to take advantage of a pre-qualified environment with an executed installation qualification (IQ) and operational qualification (OQ) performed by OpenText. OpenText also provides ongoing managed services, leaving Catalent free from time-consuming administration.

Fernandez noted, “OpenText is much better positioned to manage our infrastructure than we are, thanks to the certifications they have, the maturity of solutions that they offer, and their experience supporting other companies in the life sciences space.”

Trusting the experts for a smooth deployment

Catalent worked with OpenText™ Professional Services to map their business specific processes and requirements to the solution to configure the environment in a private cloud.

"Our experience with OpenText Professional Services has been top notch,” confirmed Fernandez. “They've helped us through the journey of going from multiple legacy systems to a market-proven industry solution that meets large enterprise needs."

OpenText™ Learning Services also assisted in creating training materials to help users get up to speed with the new OpenText Documentum Content Management solutions. As part of that process, the team harnessed AI to translate training guides and instructional videos into multiple languages.

Erik Dustrude, manager of quality enterprise systems at Catalent, recalled, “With OpenText, we were able to create very helpful training materials for our global workforce. Using AI really helped speed up the localization process, allowing us to offer learning content in seven different languages.”

With OpenText, we were able to create very helpful training materials for our global workforce. Using AI really helped speed up the localization process, allowing us to offer learning content in seven different languages.

Erik Dustrude
Manager of Quality Enterprise Systems, Catalent

Results

OpenText Documentum CM for Life Sciences has helped Catalent cut paper usage by as much as 30% while supporting swift, secure information access for more than 16,000 users across the globe.

Unlocked scale and innovation with cloud services

By moving document management to the OpenText Private Cloud, Catalent can scale services much more easily, rolling the solution out to multiple sites and freeing up internal resources to focus on innovation. This is helping the company drive more efficient growth.

Dustrude said, “One of the advantages of having a private managed cloud platform is that we get to focus on how the system will be used instead of on running the system itself. This allows us to create a much richer experience for users and be a better support to the business.”

Reduced paper usage by up to 30%

Going digital has enabled Catalent to dramatically reduce the amount of paper used in day-to-day operations. The days of shuffling through hundred-page documents are over. Now, teams have access to all the information they need at their fingertips.

“A year and a half ago, we had 15 manufacturing sites using paper-based document management systems,” explained Fernandez. “Today, we’ve reduced the amount of paper in our manufacturing operations by up to 30%. That has a hugely positive impact on our environmental footprint.”

Streamlined processes with standardized workflows

By reducing reliance on paper and introducing standardized content management processes, Catalent is bringing greater efficiency, accuracy, and consistency to its global operations. This makes it easier for the company to strike that much-sought-after balance between speed and quality.

Dustrude concluded, "With OpenText Documentum CM for Life Sciences, we have workflows that operate consistently every time. It allows our people to work quickly and with confidence that they’re following the right procedures. And this allows our business to get products off the production line faster, while maintaining very high levels of quality and robustness.”