Implement and manage Veeva to improve business process effectiveness and efficiency
Veeva Quality Management System (QMS) Implementation
Managed the implementation of Veeva QMS Change Control, Deviation, CAPA and Product Complaints
Challenge
- Our pharmaceutical client’s existing Quality Management System (QMS) could not adapt to evolving business needs, and did not adhere to the client’s cloud-based IT strategy
- End users resisted using QMS due to increased inefficiencies over time
- Users implemented manual workarounds to combat the inefficiencies, which opened the client to compliance risks
Solution
- Client selected Veeva QMS to support future-state business processes
- Created a single, integrated program plan that balanced Veeva’s standard implementation approach and client’s robust validation requirements
- Led the Veeva QMS implementation and validation
- Aligned new users around new technology and processes
- Identified new and current business needs for future Veeva QMS enhancements
Results
- QMS solution configured based on business processes
- Flexible platform positioned to support long-term business needs
- Reduced compliance risk associated with deviations, CAPAs, audits, and product complaints
- Cloud-based platform reduces need for internal infrastructure management
Are you struggling to solve your quality compliance issues?
Veeva Submissions Implementation
Managed the implementation of Veeva Submissions and Submissions Archive for a small, pre-commercial pharmaceutical company
Challenge
- A small, pre-commercial pharmaceutical company was preparing for its first drug launch
- Regulatory Submissions were time-consuming, risk-prone, semi-manual due to use of outdated IT systems (e.g., file shares without versioning, workflow, or digital signatures)
- Regulatory systems needed to be upgraded to support current and future submissions and filings
Solution
- Implemented Veeva Regulatory Submissions as the single Regulatory Affairs submissions system
- Coordinated the configuration of Veeva Submissions Archive for use in electronic archiving
- Connected Veeva Submissions and InSight Publisher through the InSight Connector
- Updated business processes to define standard use of Veeva Submissions
Results
- Increased productivity and efficiency in regulatory submissions
- Data consistency through use of versioning and user-based access permissions
- Single source of truth for submissions and filings
- Interoperability between Regulatory Submissions and Publishing Systems
Need help improving and optimizing your regulatory systems?
Veeva eTMF Remediation
Analyzed and updated client’s business processes to more efficiently utilize Veeva eTMF
Challenge
- Clinical Operations and study personnel at a pharmaceutical company participated in an EMA inspection of their TMF
- The inspection uncovered deficiencies in electronic document acceptance
- The existing Veeva eTMF configuration, and associated processes, were not mature enough to mitigate the EMA inspection
- Remediation of the eTMF had to be completed in 4 months
Solution
- Created transmittal form to facilitate scanning and attaching files for upload to Veeva eTMF
- Implemented custom configuration to Veeva eTMF to support transmittal form, document reclassification, and new metadata
- Updated business processes, and trained end users on use of transmittal form and creation of digital record in Veeva eTMF
Results
- Satisfied EMA requirements for electronic document capture and reconciliation
- Transparency throughout the document life-cycle, including status and approval
- Ability to use additional, customized Veeva eTMF functionality
Looking to improve your content management systems for your clinical operations and study data?
Veeva Release Management and Center of Excellence
Analyzed client’s evolving needs and developed strategies to maximize the efficiency of their portfolio of Veeva solutions
Challenge
- Our client implemented numerous Veeva products supporting many functions: QualityDocs and QMS to support Quality, Submissions and Submissions Archive to support Regulatory, eTMF to support Clinical, and PromoMats and CRM to support Commercial
- There was no mechanism to support each system after deployment
- Many maintenance and enhancement requests were ignored or lost
- Stakeholders were “in the dark” and frustrated
- Key platform features were not implemented
- Support team unable to understand current or future resource needs
Solution
- Defined clear roles and responsibilities between various functions and IT
- Developed process to intake, assess & prioritize, implement, and deploy Maintenance and Enhancement (M&E) requests in a compliant manner
- Implemented a tool to track and manage all M&E requests in a single repository
- Developed reports to track important metrics over time (i.e. requests received by month, request delivery time)
- Established regular checkpoints with stakeholders to ensure consistent alignment throughout the process
Results
- During the first twelve months, delivered 50+ M&E requests while simultaneously deploying three planned Veeva releases and delivering multiple new projects
- Reduced average delivery time of M&E requests by 52% (from 30.5 days to 14.5 days) within six months
- Improved ability to forecast future resource needs based on M&E trends
- Improved stakeholder expectations and satisfaction through consistent delivery of ongoing system enhancements
Want to keep your Veeva platform usable, add new features to improve it, and fix issues in a timely, consistent, and compliant manner?
CONTACT US
How can we help you?
[fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][Form id=”7″]
[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]