Enhancing Veeva Vault’s content management capabilities with Tridion Docs

Recently, Tridion’s team convened with its partner Prana Life Sciences LLC (PLS), to discuss the joint value proposition of both companies. Elsa Sklavounou, RWS, VP AI Alliances, Global Partnership, organized the event.

From the PLS team, Bhaskar Kende (Co-founder) walked us through Prana Life Sciences’ solutions and how PLS and Tridion deliver strong value propositions to enterprise customers. PLS is a services partner to Veeva Systems, Inc., a world-renowned SaaS provider for global life sciences companies.

As a reminder, Tridion provides its life sciences customers with a connector to the Veeva Vault document management system to help them benefit from Tridion Doc’s advanced authoring and component content management features.

PLS services overview

Bhaskar mentioned that he and the other co-founder, Giri Masireddy, bring over 40 years of combined experience in the content management space for the life sciences sector. PLS currently offers several Veeva implementations for its clients:

• Quality (QualityDocs, QMS, Training / LMS)
• Regulatory (RIM)
• Commercial (PromoMats, MedComms, CRM)
• Safety and Safety Docs
• Clinical (CTMS, eTMF, EDC)
• Medical

Areas in which Tridion Docs brings value

From Tridion’s perspective, Bhaskar mentioned that there is opportunity in the Quality part of the implementations, whether it is QualityDocs or Quality Management System (QMS).

Based on PLS’s experience with Veeva Docs, Bhaskar believes Tridion Docs can improve Veeva Docs’ efficiency. It especially complements Veeva Docs in three areas:

Collaborative Authoring

Specifically, Bhaskar mentioned that in Veeva’s collaborative authoring, the data relating to the changes made during various reviews is lost. With regards to processes, Bhaskar mentioned that Veeva’s features fall short when it comes to enabling consistent document authoring across multiple systems. Tridion Docs excels in this area and can bring much efficiency that is needed today.

Process Harmonization

Bhaskar mentioned that documents in Veeva are not saved on a single platform. There are different vaults for storing different documents, e.g., a document primarily about Clinical data goes in the Clinical vault, while the one mainly relating to regulations goes in the Regulatory vault. This creates content silos because these documents are often interconnected and need to speak to each other.

With a Component Content Management System's capability such as Tridion Docs, this issue can be addressed as the data that needs to be shared among these vaults can easily flow on per need basis from a single platform.

Automatic Translation

In Veeva, there is no automatic translation; every document needs to be rewritten in each language. Further, any edits made in the original document must be incorporated separately in each language. In Tridion Docs, it is all automated, thus saving significant time and cost.

Bhaskar opened the forum to the Tridion team to share their inputs on other areas in which Tridion Docs can bring value to Veeva Vault users. Chip from the Tridion team highlighted one of the essential features of Tridion Doc: component content management. And when the content is componentized, it makes it easily reusable across multiple scenarios.

Chip mentioned that Pharma companies benefit immensely from this component-level content management and reuse. Tom from Tridion mentioned how Tridion can work to improve collaborative authoring for Veeva Vault customers’ needs to be evaluated, especially while working with Microsoft Word. Bhaskar agreed that this area can be explored at a more granular level going forward.

The four-stage Veeva implementation approach

Bhaskar shared a methodical approach that PLS takes to implement Veeva; it includes:

1. Understand business processes and create SOPs, work instructions, job aids
2. Prepare training materials and educate the trainers
3. Establish change control and support the ticketing process
4. Capture new enhancements and release management

Also, PLS performs all the customizations for Veeva Vault customers. Bhaskar shared some examples that include customizing:

• User roles and security permissions
• Document templates and workflows
• Fields, page layouts, and related objects
• Reports and dashboards

 Further, PLS also develops new objects, brings automation to minimize the number of clicks, and performs system integrations with apps such as clinical site visit reporting or single sign-on.

PLS’s role in introducing Tridion Docs to Veeva customers

Bhaskar believes that, at first, Veeva Vault customers would need validation that Tridion Docs offers a lot of value and can seamlessly work with Veeva Vault. PLS can play an important role here in providing such validation. Bhaskar mentioned that PLS is open to using either Computer System Validation (CSV) or Computer Software Assurance (CSA) approach. However, he specified CSA approach is most preferred by customers today.

He also clarified that PLS can perform validation for customers that have already implemented Tridion Docs and want to validate its working with Veeva Vault. PLS will also help customers with validating Tridion Docs for major upgrades, enhancement from change requests, and as a part of system integration and data migration.

Chip from Tridion raised a question about the customer’s expectations from technology vendors like Tridion. Bhaskar mentioned that Tridion should provide the customer with all the features being provided in a documented form. Further, there should be documented evidence of testing performed for all these features and against all the customer requirements.

The requirements can be operational, security-related, compliance-related, or legal in nature. For some of these requirements, testing may not be possible, e.g., if Tridion is using any cloud platform, then testing the platform may be out of scope. However, Tridion should have the cloud platform vendor qualification documented. Also, IT practices and controls in place to make Tridion work should be documented.

If a customer makes any customizations to Tridion Docs features, testing or validating those features becomes the customer’s responsibility. This is where partners such as PLS itself play a vital role and perform customer testing.

Bhaskar mentioned that PLS team is working in close collaboration with RWS’s professional services to study Tridion Docs in detail to help produce it as a validated product for end customers. Elsa elaborated that the collaboration is at a primary stage where it is more educational, helping PLS understand the GxP when speaking about Tridion Docs with end customers.

Bhaskar summarized the various steps involved in the validation process. It includes system requirement specification, risk assessment, validation plan, traceability matrix, and validation summary report.

Ed from Tridion brought up a question regarding using Agile methodology for validation. Bhaskar mentioned that end-to-end Agile is not possible due to the nature of deliverables. However, hybrid models are being widely adopted. At PLS, Agile methodology is closely followed for product or solution development. Bhaskar mentioned that the PLS team is open to working on current hybrid models with Tridion to make it more Agile going forward.

In closing comments, Bhaskar mentioned that during his experience in the Life Sciences space, he encountered several IT problems and formed PLS to help companies overcome them. And he is confident that Tridion Docs, especially its structured and componentized content capabilities, would allow companies in the Life Sciences to overcome the significant IT challenges they are facing today.

If you would like to learn more about how Tridion can help your business, click here.