NNIT Veeva Vault Insights

Veeva Vault offers several powerful reporting-related features, especially relevant within the Vault Quality Suite, which includes specific reporting functionality. In this article, we will discuss the various standard Vault and Quality Suite specific reporting features and how they allow customers to retrieve information relevant to their business from within the Vault environment.

Vault Platform Standard Reporting and Dashboards

The foundational reporting capabilities of the Vault Platform allow users to execute both simple and complex reports. These reports can display data in a standard tabular format or involve intricate combinations of data from different record types or documents. Users can create these reports from scratch using predefined "Report Types" or utilize previously formatted reports that can be shared with groups or individuals. Additionally, these reports can be scheduled as "Flash Reports" to run automatically and be sent to specific users daily, weekly, or monthly.

Dashboards visually represent the stored information and may include formats such as pie charts, line charts, and gauges. They depend on Vault reports for data and vary based on the configuration of the referenced report.

Advanced Platform Reporting

In addition to the standard reporting capability, Vault has the following more advanced features:

Matrix Report Format

Instead of listing results in a row-based table format, a matrix report format is available. This allows the results returned to be grouped on both the X and Y axes, with individual cells containing a calculation on the grouping (available calculation options are Count, Sum, Average, Minimum, Maximum). This type of report is useful to convey summary information, such as summarizing the number of Quality Event records grouped by Quality Event Type and Status.

Formula and Conditional fields

In addition to simply including individual document or record fields within reports, Vault allows users to create formula fields that can return formatted or calculated information such as if records were closed on time.
There is also the possibility of creating conditional fields which return values based on other fields. These are primarily used to group results in a way which is not possible through the grouping available with normal field data – for example, returning customer-specific ranges of records classed as being on-time, nearing due date, or overdue.

Excel Templates

For any tabular format type report it is possible to attach an Excel file containing a pre-defined layout. This file can then be used by users to export their report results to Excel. As this pre-formatted file could contain Excel components such as tables, macros, formulas, or any other Excel feature they can be a powerful tool for users to convey simple or complex information in a user-friendly format.

Formatted Outputs

When a detailed report for one Vault record is required, a Formatted Output report is a mechanism available to create a PDF format representation of it. The report can include information from related records and documents, and can be formatted in various ways. Advanced logic can also be included to perform calculations and report on them.

Vault Quality Suite specific reporting

Within the Vault Quality Suite, the following additional features are available:

Automatic Report document creation

Reports are a key component of many business processes, especially in areas such as auditing. To help streamline the creation and management of reports, Vault can automatically create document reports when QMS records progress through their lifecycle. These reports can be created from Formatted Output templates, Document Templates, or standard Vault reports, and would contain specific information from the QMS record and its related records. They are saved as normal Vault QualityDocs documents, and can then be progressed through a document lifecycle or kept as a read-only snapshot of a record at that specific time.

Annual Product Quality Reviews 

To support an Annual Product Quality Review (APQR) process, Vault QMS includes functionality that assists the creation of a final APQR report. This is achieved through the use of pre-defined Management Review Templates ,which capture the items expected in the review process, and are used to manage the documents and other information which should be included.
Vault Binder functionality is subsequently used to group all the documents included in the template together into one item within the Vault Library, which can then be used to generate the final PDF format final report.

Cycle Time Metrics 

Vault QMS also includes functionality to help customers monitor the efficiency of their QMS processes by automatically capturing the start and end times of specific phases within the processes, along with additional information such as the difference to the expected end time.

Cycle Time Metrics are currently supported on Quality Events and Audit records, allowing customers to retrieve information without the need for complex configuration. Some minor configuration is required to enable the functionality.

With our knowledge of core Vault and Vault Quality Suite features, configuration options, integration touchpoints, and business processes, NNIT is equipped to assist customers in implementing these features efficiently, enhancing data management and maximizing the value of data entered and created by Veeva Vault.

Veeva have been adding significant new features related to Audit Management to the Vault Quality Suite in recent releases. For the latest 23R3 release an eagerly awaited Auditor Management feature is available, allowing organizations to have more control on who can participate in Audits.

With the addition of this new capability Veeva have again demonstrated that they are listening closely to the market and can quickly add new features and make significant functional improvements.

Whilst this is a massive benefit to customers and highlights an advantage of the SaaS model, there are always challenges with the continuous introduction of new Vault features. These include:

• Gaining the appropriate level of knowledge
• Identifying which features to progress and which are of most relevance to the business.
• Identifying the business impact of implementing features and the steps required to deploy them.
• Identifying how to technically implement the features, taking into account factors such as the existing Vault configuration, integrations and other already planned work

 

These challenges are partly mitigated by the work the Veeva Customer Success team perform and the documentation Veeva make available, but NNIT can help fill in any gaps by assisting customers with:

• Detailed knowledge sharing sessions, Customer Specific Proof of Concepts
• Business advisory, Change Support
• Technical implementation
• Impact assessments
• Test and Validation

 

With our knowledge of Vault Quality Suite features, configuration options, integration touchpoints and business processes, NNIT have the skills to help customers implement new features quickly and seamlessly.

Complaints management is a critical aspect of quality management, and leveraging Veeva Vault QMS can significantly enhance this process. As a trusted partner of Veeva, NNIT is committed to assisting customers in optimizing their complaints management journey through cutting-edge technology. In this article, we explore the key features of Veeva Vault QMS that empower customers to streamline their complaints processes and drive added value to their business.

Complaint creation

Complaints management begins with receiving complaints. These can originate from a number of sources, including telephone, email, websites or separate systems. While manual creation of a complaint in Vault is possible for users with the appropriate permission, there are other automated options available.

Email ingestion

The most useful automated approach available is for emails, where customers can have a set-up where users email their complaints directly into Vault. With Vault's standard "email connector," users can seamlessly email their complaints directly into the system, eliminating the need for custom code or third-party integrations.

Vault ensures that any email replies to the original email sent to Vault do not create a new complaint in the system. Instead, the information is associated to the original complaint. The primary component within this automation is the Vault email inbox, where emails from complainants will be sent to. Customers would need different email inboxes for different types of complaints and have control on who can send emails to each inbox. Customers also have options within their own email server architecture to forward or re-direct emails from other email addresses to the Vault email inboxes.

Other integration options

Receiving complaints via integrations from other systems or sources is also possible, with the Vault API allowing a range of possible approaches. These could vary from simple website-based forms to integrations with separate complaint related systems.

Processing complaints

Customers have full control over the behavior of a complaint after it is created in Vault, including:

• The path it can take prior to being closed.
• Which users are involved in evaluating and reviewing it.
• Which users can see it during its life.

 

Complaints can be linked to other records and processes, such as investigations, CAPAs or other complaints. They can also use additional Vault functionality such as root cause analysis, effectiveness checks and extension requests.

Communications and reporting

Correspondence with the complainant or other relevant users is an important part of a complaint process, and Vault includes specific functionality to support this.

External Notifications

Is a feature specific to Vault QMS, allowing users, whether internal (such as a QA user) or external (such as the originator of the complaint) to receive notifications based upon pre-defined templates.

These pre-defined notifications can be sent manually during complaint processing or automatically as the complaint reaches specific points in the process. The notifications can also include links to view documents stored in Vault, with the possibility of the link being time limited. This can be especially useful when Vault QMS functionality to create reports automatically is employed – Vault can for example create a report on a complaint based upon a pre-defined report template and store it as a Vault document. This can then be shared with users and used for future reference.

An additional notification related functionality available is Issue Escalation. This allows a complaint to be escalated to management via a simple mechanism, with notifications to users external to Vault being possible. A record of all the notifications sent as part of the Issue Escalation is kept, giving traceability and a transparent way to reference them later if needed.

Summary

Veeva Vault QMS offers a suite of features that, when combined with standard Vault platform capabilities, creates a robust complaints management system. With NNIT's expertise in Vault QualitySuite features, configuration, integration, and validation, customers can swiftly implement and optimize complaints management processes to drive business excellence.

In today’s interconnected world, seamless collaboration with external partners is crucial for maintaining a competitive edge and accelerating project timelines. Veeva Vault’s External Collaboration functionality is at the forefront of this transformation, ensuring that businesses can engage with stakeholders efficiently and securely. This article highlights the key collaboration features, benefits, and implementation considerations.

Introducing External Collaboration

Veeva Vault allows direct collaboration by providing external stakeholders with temporary access to the Vault for document review and approval tasks. This functionality aims to streamline workflows and improve efficiency by reducing the reliance on emails and third-party eSignature solutions.

How It Works

Once a document is designated for external collaboration within Vault, specific fields trigger a workflow that includes external collaborators. These collaborators are automatically provisioned with a user account with limited permissions, ensuring security and compliance. After completing the review and approval tasks, the user account is deactivated and integrated back into the system.

Key Features and Benefits

• Streamlined Workflows: Automatically provisions external users and integrates them into document workflows, reducing manual intervention.
• Enhanced Security: Provides temporary, tightly controlled and monitored access, reducing potential security risks.
• Regulatory Compliance: Ensures adherence to industry-specific regulations, which is crucial for sectors like healthcare and finance.
• Efficiency Gains: Speeds up the review and approval process, helping to shorten project delivery times.

Additional Features

External Collaborator Assignment Records: Optional tracking for all external collaborations, offering insights into past and current activities, to enhance oversight and auditability.

User Status Tracking: Adds a status field to each external collaborator’s record, providing clear visibility into whether they are active, inactive, or have never been users.

Feature Considerations & Limitations

Single Document Workflow Support: The functionality is currently optimized for single-document workflows, which may not suit all organizational needs, especially those requiring multi-document reviews.

User Cap Restrictions: There’s a cap on the number of external users that can be active at the same time, which might limit scalability for larger projects.

Limited Workflow Actions: External collaborators can only participate in "Document Review" and "Document Approval" tasks, which might not cover all the necessary external collaboration scenarios.

Restriction on Collaboration: Supports a maximum of three external collaborators (new feature introduced in 24R2) for single document review and approval tasks, limiting the number of stakeholders that can be involved simultaneously.

Implementation Considerations

Role Configuration: Careful configuration of roles and permissions is necessary to balance security with accessibility.

Monitoring and Audits: Regular reviews of external collaboration activities help ensure that the processes remain secure and compliant with evolving regulations.

Customization Needs: Depending on the specific requirements and the regulatory environment, additional customizations might be needed to fully leverage this functionality.

Partnering with NNIT Quality Solutions

For organizations seeking to implement the Veeva Quality Suite—including QualityDocs, QMS, Training and Validation Manager—NNIT Quality Solutions offers unparalleled expertise. NNIT’s deep understanding of regulatory requirements and industry best practices ensures that your implementation is both efficient and compliant, paving the way for a smoother digital transformation.

Conclusion

Veeva Vault's External Collaboration functionality not only streamlines how companies interact with external entities but also ensures that these interactions are secure and compliant. By integrating external stakeholders directly into the document management workflows, Veeva Vault Quality Suite enhances operational efficiency and keeps collaboration straightforward and controlled.

Veeva Vault provides great capabilities for document management. By leveraging fields and metadata, users can efficiently locate documents through reports, filters, and predefined views. However, this system can be challenging for casual users who may feel overwhelmed.

The Process Navigator provides an intuitive alternative method for locating documents in Vault. It minimizes the need for extensive user training by enabling navigation through the document landscape with a process centric view.

Improving user experience

In many Vaults, you’ll find poorly maintained binders, often created by users who struggle to find relevant documents using the standard library view. This issue not only poses potential compliance risks but also indicates that users may not be fully adapting to Vaults metadata – based approach.

The process Navigator offers a user-friendly alternative. Users can simply click through the process hierarchy until they reach the process level relevant to their current task. From there, they gain access to information, links, and all relevant procedural documents, forms and templates associated with that process.

Understanding your business processes

It’ is essential for your organization to fully understand the process areas you wish to integrate into the process navigator. Begin by capturing your entire process landscape and harmonizing it across different business areas. This initial step will help identify overlaps and misalignments between processes, preventing rework as you expand usage to additional processes.

Although this initiative may be challenging, it significantly enhances business value by creating transparency around processes and roles, thereby establishing a strong foundation for your QMS.

Mapping your documents

The Process Navigator links defined processes to relevant documents. Once your organization has a clear understanding of its process landscape, you should map documents to the appropriate process level. While this can be a great exercise in refining your document set-up, it may also be somewhat cumbersome.

AI tools can facilitate this process. For example, NNIT has an in-house solution that can analyze your existing SOPs and other procedures giving analytical insights and saving valuable time and resources.

Technical Considerations

Implementing the Process Navigator does not affect existing configurations such as security and access settings. If users already have access to the right documents, the only change will be how they locate them in Vault.

However, it’s important to note that adding the process navigator introduces a new feature that requires a new process for administration and maintenance.

Therefore, it’s essential to clarify responsibilities and ensure that those responsible for managing the navigator are adequately trained, securing a smooth post-implementation process.

A process centric & role based approach is the cornerstone of every successful QMS.

NNIT has developed a methodology that can assist your organization in adapting existing structures, ensuring a stable and effective foundation for the future.

The Process Navigator can be a powerful tool for enhancing user adaptation and efficiency in Veeva Vault.