System Implementation
Quick Navigation: Overview • Challenges • Typical Engagement • Our Approach • Client Profile
Service Overview
System implementation in life sciences requires strategic business analysis before technical execution to prevent expensive decisions based on incomplete requirements. We provide comprehensive implementation support from initial business case validation through go-live and optimization, ensuring technology investments deliver measurable business outcomes while maintaining regulatory compliance and operational continuity.
Common Challenges
Organizations struggle with implementations that exceed budgets and timelines due to poorly defined success criteria, technology selections that don’t align with actual business requirements, and system integrations that fail because stakeholders didn’t understand operational dependencies. Specific situations requiring strategic implementation management include:
Business case validation where organizations must verify whether new systems actually address operational problems or just create technology overhead without improving business outcomes. Requirements definition that establishes clear success criteria, KPIs, and risk indicators to measure implementation success against business objectives rather than just technical functionality.
Vendor assessment and selection where technology capabilities must be evaluated against actual operational workflows and integration requirements rather than feature checklists or vendor demonstrations. Contract negotiation that establishes clear service level agreements, support structures, and performance metrics while protecting organizational interests during implementation and ongoing operations.
Team alignment and project governance ensuring cross-functional stakeholders understand their roles, responsibilities, and success criteria throughout implementation planning and execution phases.
Technology due diligence for M&A where system architectures, data flows, and operational dependencies must be evaluated to assess integration complexity, identify hidden technical debt, and quantify post-merger system harmonization costs and timelines.
Clinical platform implementations involving CTMS, CDMS, eTMF, eCOA, and safety systems that require complex integrations between sponsors, CROs, and technology vendors while maintaining data integrity and regulatory compliance. Cloud migration projects where validated on-premise systems move to cloud infrastructure requiring new integration architectures and validation approaches.
Manufacturing execution system implementations that must connect with ERP, quality, and regulatory systems while maintaining production schedules and GMP compliance throughout the transition period. Digital validation platform deployments using tools like Valkit that must integrate with existing validation processes and documentation systems while ensuring SaaS IQ/OQ dependencies are properly managed.
Data migration and ETL projects where years of historical data must be cleaned, transformed, and transferred without losing audit trails or regulatory compliance status. System transitions and end-of-life management where legacy systems must be maintained for historical data access while new platforms handle ongoing operations.
Multi-vendor integrations where different technology solutions must work together to support end-to-end business processes, requiring careful coordination of technical interfaces, SLA management, and ongoing vendor support communications.
Most implementation failures occur because teams focus on individual system functionality rather than understanding how systems must work together to support integrated business operations and regulatory requirements.
Recent Engagements
- Pharmaceutical manufacturer implementing integrated ERP-QMS-LIMS platform across five manufacturing sites while maintaining production schedules and regulatory compliance
- Biotech company deploying cloud-based clinical data management system with real-time integration to safety databases and regulatory submission platforms
- CRO implementing unified project management platform connecting CTMS, financial systems, and client reporting tools across multiple therapeutic areas
Typical Engagement
Duration: 4-8 months for major implementations, ongoing for optimization and support
Deliverables: Requirements analysis, workflow documentation, integration architecture, validation planning, implementation roadmap, testing protocols, go-live support
Client involvement: Executive sponsorship essential, cross-functional project teams, end-user participation, change management coordination
Engagement model: Project-based for specific implementations, retainer-based for ongoing system optimization and support
Our Implementation Approach
1. Business Case and Strategic Analysis We verify whether technology investments actually address operational problems and establish measurable success criteria, KPIs, and risk indicators before technical planning begins.
2. Workflow Documentation and Requirements We map how work actually gets done across current systems before designing integration requirements, preventing solutions built for theoretical processes that don’t match operational reality. 3. Data Architecture and Migration Planning We analyze existing data structures, migration requirements, and ETL processes to ensure data integrity throughout system transitions while maintaining historical access and audit trails.
4. Integration and Reporting Design We plan how data flows between systems and how users will extract critical information, recognizing that reporting capability is often the primary business justification for system implementations.
4. Validation-Aware Implementation We integrate CSV requirements into system design from project inception, ensuring validation activities support rather than delay implementation timelines while maintaining regulatory compliance.
5. Vendor Management Framework We establish clear SLAs, communication protocols, and support structures for ongoing vendor relationships, particularly critical for SaaS platforms where IQ/OQ validation depends on vendor cooperation and system reliability.
6. Training and Adoption Planning We design user training programs that ensure personnel can effectively operate new systems within regulatory requirements, recognizing that no system can go live without comprehensive user competency.
Integration Points
System implementation connects with all other compliance and operational functions - validation planning must begin during requirements definition, change management programs ensure user adoption and process compliance, and ongoing system maintenance requires integration with quality management and risk assessment frameworks.
ISO certification and GxP compliance requirements must be embedded in system design rather than added as afterthoughts, while training programs ensure users can effectively operate new systems within regulatory requirements.
Client Profile
Organizations implementing new technology platforms or upgrading legacy systems where implementation complexity could derail project success or regulatory compliance. Particularly valuable for companies managing multi-vendor integrations, complex regulatory requirements, or business-critical systems where downtime or data loss could significantly impact operations.
Ready to discuss your implementation challenges? Contact us to explore how systematic implementation planning can prevent expensive surprises and ensure successful technology deployments.
Connect with Kevin Shea on LinkedIn for ongoing insights on life sciences technology and compliance.