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.