Catalent Case Study

Catalent’s Journey of Continuous Improvement for Computer System Validation Excellence.

Case in Brief

Catalent’s story underscores the importance of continuous improvement in the life sciences sector. By regularly reevaluating and upgrading tools and processes, companies can stay ahead of industry trends, enhance efficiency, and foster collaboration across global teams.

This case study showcases Catalent’s strategic upgrade of ValGenesis' digital validation solution, reflecting its commitment to industry advancements and ongoing growth.

Results Highlights

• Successfully upgraded ValGenesis to integrate new features and align with refined CSV processes

• Enhanced global team collaboration through improved system performance and streamlined validation

• Strengthened data integrity and security with refined role-based access

• Reduced review and approval time from one week to half a day

Customer Profile

Catalent is a global leader in helping pharmaceutical, biotech, and consumer health companies optimize product development, launch, and full lifecycle supply for patients worldwide. With extensive expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the preferred CDMO partner for personalized medicines, blockbuster drugs, and consumer health products.

Headquarters: Somerset, NJ, USA
Employees: 18,000
Founded: 2007
Featured Activity: Computer System Validation (CSV)

Optimization and Improvement

As a global leader in CDMO services, Catalent is committed to upholding the highest standards of quality and efficiency. To stay ahead of the industry’s evolving demands, the company regularly reevaluates its processes and tools, ensuring they remain aligned with operational goals and support continuous improvement.

In 2021, Catalent embarked on a strategic rewrite of its internal CSV validation master plan, along with a continued evaluation of ValGenesis to explore opportunities for further enhancement.

While the initial implementation of the system in 2017 delivered significant benefits, such as streamlined validation procedures, paperless test execution, and faster review and approval cycles, Catalent saw an opportunity to further optimize the platform in preparation for an impending system upgrade.

Leading this comprehensive optimization project were Laurie Lipper, Catalent’s IT Computer System Validation Manager, and Jeff Onis, Catalent’s Global IT Data Integrity Manager.

“We needed to ensure that all refined SOPs, templates, and documents from the new validation master plan were seamlessly incorporated into ValGenesis,” explained Lipper. “The challenge of learning the system, upgrading it, and aligning it with our new data integrity program and validation master plan was complex—there were many moving parts.”

The ValGenesis Delivery Team played a pivotal role in this endeavor, providing essential support to bridge the gap between Catalent’s needs and the system’s capabilities.

“Working with ValGenesis was great,” Onis noted. “They helped us align the system with our new CSV program and uncover opportunities for process improvements and efficiency gains to maximize value.”

Industry Insights

Today’s contract development and manufacturing organizations operate in an increasingly competitive and complex environment. The demand for faster drug development, personalized medicines, and global scalability has never been higher. Forward-thinking CDMOs are leveraging digitalization, automation, and advanced analytics to enhance efficiency, maintain quality and accelerate time to market. Digital solutions that streamline validation are central to this transformation. By staying ahead of technological advancements and regulatory changes, these CDMOs not only meet the current needs of their clients but also anticipate future demands, ensuring they remain competitive in a dynamic global market.

Strategic Actions and Lessons Learned

As newcomers to the ValGenesis system, Lipper and Onis needed to acquire the knowledge to lead the optimization project effectively. This involved not only mastering the system’s technical aspects and understanding the newly refined validation package but also becoming familiar with the validation package established years earlier when the system was implemented.

During the integration of new CSV processes and documents into ValGenesis, the team identified areas for improvement. They discovered the original configuration of the system could be enhanced by using the improved capabilities of the latest release to align with the team’s evolving needs.

The Importance of Scalability

As Catalent acquired additional systems and expanded its global operations, it became clear that the initial ValGenesis setup required scaling.

“When we rolled out ValGenesis in 2017, it was tailored to validate a single ERP system. As our global operations grew, we faced the challenge of extending the system’s use to additional platforms,” Onis noted. “ValGenesis’ scalability has enabled us to expand and adapt it to our broader validation needs. Now we manage over 25 global IT systems in ValGenesis.”

Getting Granular with Roles and Privileges

The team saw an opportunity to enhance efficiency by aligning user access more closely with jobspecific requirements. By reconfiguring roles and permissions, they not only streamlined system use but also bolstered data integrity and security.

This initiative included redefining role profiles to align with updated processes, thoroughly testing new configurations, updating SOPs, executing change controls, and reassigning over 500 global users.

“We worked through role profiles one by one, consulting with managers to determine the best fit for each user’s job function,” Lipper explained. “ValGenesis provides an exceptionally detailed level of configuration for user roles, which we've found to be incredibly powerful and effective.”

Refining User Training

Catalent recognized significant opportunities to improve internal training processes. They overhauled user and administrator SOPs, updated training materials, and introduced more personalized one-on-one sessions. This hands-on approach was particularly beneficial for users whose roles and privileges had been adjusted during the reconfiguration.

Enforcing Standardization

One of ValGenesis’ key advantages is its ability to enforce standardization, which strengthens compliance and reduces the cost of quality. Recognizing they weren’t fully leveraging this capability, the team redoubled their efforts to standardize terminology across the platform. For example, they replaced the term “deviations” with “exceptions” to differentiate between quality system deviations and validation effort protocol exceptions. This change reinforced consistency and clarity within their processes.

Results and Benefits

Catalent’s strategic optimization and upgrade project yielded transformative results, significantly enhancing the CDMO’s use of the ValGenesis system. By leveraging insights from the initial implementation and revamping its CSV program, Catalent has been able to unlock even greater efficiencies.

Enhanced Data Integrity

ValGenesis supports ALCOA++ principles for data integrity, which is essential to ensuring compliance and accountability. “There are a bazillion audit trails in the system that allow you to track who did what and when, with immutable date and timestamps. So you’re certainly being traceable and attributable,” said Onis, underscoring the system’s effectiveness in maintaining data integrity.

Single Source of Truth

ValGenesis acts as a secure, centralized repository for all validation lifecycle documents, eliminating the need for unsecured file storage and ensuring that all records are consolidated in one place. “ValGenesis is our go-to; it’s the original record source that fully complies with Part 11 and Annex 11 requirements,” stated Onis.

Reduced Audit Stress and Prep Time

A major advantage of ValGenesis is its ability to streamline the search and retrieval of critical documentation. Documents are categorized and easily searchable by system name and document type. “When you receive a list of documents needed for an audit, it’s much faster to search for those documents in ValGenesis,” Lipper noted. “You navigate through the categories and either print or provide a PDF copy electronically, which drastically cuts down on prep time.”

Global Collaboration and Flexibility

For Catalent’s globally dispersed IT team, ValGenesis has proven essential. The system supports effective remote collaboration, accommodating team members who operate without a physical site. “A system like ValGenesis is a necessity for us at a global IT level,” said Onis, illustrating the system’s role in facilitating global operations.

Improved Employee Satisfaction

The flexibility and remote work options enabled by ValGenesis have increased employee satisfaction. The system allows internal team members and Catalent’s contractor-based workforce to manage protocols efficiently, free from paper-based constraints. “The proof is in the pudding, every day, dozens of documents route seamlessly through the system, managed by team members from projects worldwide,” Onis said.

Game-Changing Electronic Execution

Before ValGenesis, neither Onis nor Lipper had experience with a digital validation management system, and they found paper-based validation laborious and error-prone.

“We’d print out the validation protocol on site. Someone created a logbook, which was printed and filled out by hand. We would summarize the data and route it through an electronic document management system, but we certainly didn’t have an electronic execution system. It’s an absolute game changer,” said Onis.

Lipper appreciates that the execution module is dedicated exclusively to the execution process, with clear signatures, dates, and times. This clarity ensures that all execution data is accurate and easily accessible. Once executions are approved, the system supports a thorough review of the documentation, streamlining finalization and confirming completeness.

Easier Evidence Gathering

ValGenesis captures and embeds screen evidence directly into documentation using an integrated numbering system for easy reference. Users can take full-screen captures and include them in validation records, which helps minimize storage requirements. “ValGenesis is really beneficial because the evidence screen captures are done within the system, and the file size is minimal if you print the execution,” noted Lipper.

Better Legibility and Documentation Management

Lipper recalled past difficulties managing handwritten documents. “Colleagues would often complain, ‘I can’t read your handwriting.’ I had to strike through, initial, date, and reprint the document more legibly, explain the changes, and then the reviewer had to print, sign, and rescan it. This resulted in messy execution protocols, especially when additional signatures or notes were added.”

“With ValGenesis, everything is in a standardized electronic format. Changes are clearly visible in the execution, and the system efficiently handles signatures without requiring extra space or time,” explained Lipper.

Increased Efficiency and Reduced Delays

The ValGenesis system has greatly accelerated protocol execution and approval processes by eliminating the need for physical document handling. This improvement has streamlined collaboration across Catalent’s global IT operations, reducing frustration and effort.

“In my experience with paper processes, review and approval could take a week. Now, they can be completed in half a day or less, depending on the size of the execution and time zones of the reviewers,” said Lipper.

Enhanced Document Consistency

By utilizing standardized templates for all validation documents, Catalent ensures uniformity in its summary reports and other critical documentation.

“We’ve established templates that maintain consistency for all our global validation needs,” Lipper explained. “Users can create documents using these templates, with clear instructions on what to edit and what to leave unchanged. This eliminates the need to start from scratch, simplifying the process, and ensuring that all documentation meets the same high standards.”

Facilitates Compliance with CSA

ValGenesis is the only digital validation solution on the market that is CSA-ready and supports unscripted testing, a crucial element for modern validation practices.

Catalent engineers use the system to create detailed test script templates, which include ad hoc, unscripted, and scripted formats. This functionality supports risk analysis, defines required testing, and facilitates execution with preconfigured templates.

“ValGenesis offers extensive features for CSA,” Onis noted. “And while we’re not using all of them yet, we plan to in the future.”

Looking Ahead

Catalent plans to further expand its use of ValGenesis, with key initiatives aimed at maximizing the system’s capabilities.

One major focus is to leverage the system's trace matrix capabilities. This initiative will ensure comprehensive, real-time traceability across all validation documents, including user requirement specifications, design specifications, and functional requirement specifications. By supporting various trace relationships, this approach will help ensure that any changes are accurately reflected throughout the system, enhancing overall consistency and compliance.

ValGenesis + Catalent by the Numbers:

• 20,000 validation documents managed within the ValGenesis platform

• 25+ critical computer systems validated using ValGenesis

• 400+ global IT and local site users engaged in CSV/CSA activities