Tools and Accelerators

Project Management Tools

Clarkston’s Project Management Methods, when integrated with our solution-specific methodologies, support the smooth transition from project kick-off to solution implementation, the management of the implementation activities, and the successful completion and hand-off of the solution to the client. The PMM processes provide Clarkston and the client that standard set of activities that aid the project managers in providing ongoing managerial control throughout the life of the project, and in guiding the project managers through formal hand-off. The PMM solution delivery tools are organized into the following categories:

• Project Planning
• Budget
• Project Standards
• Change Control
• Quality Control/ SuccessCheck
• Risk and Issue Management
• Status and Performance Reporting
• Knowledge Transfer
• Project Transition

 

Change Management Tools

The Change Management (CM) Methodology is a roadmap for implementing a CM strategy tailored to clients’ decision-making and budgeting processes. It provides comprehensive plans, tools, and templates that adapt to clients’ needs and is designed to understand the human, organizational, and technological effects of business process changes. CM focuses on recognizing opportunities for continuous improvement, knowledge transfer, and coaching/guiding clients through a transformation. The objective: Clarkston provides the roadmap for change initiatives; clients use it to drive desired change throughout the organization. Our change management methodology provides 57 processes and over 100 tools, including:

• Change readiness assessments, interview guides, surveys, and results guides
• Knowledge transfer strategies, knowledge contracts
• RACI charts (Responsible, Accountable, Consulted, Informed)
• Communication plans
• Coaching plans
• Job position matrices
• Checklists
• Facilitation, visioning, and presentation plans, workshops, and techniques
• Mobilization Rollout plans

 

Life Sciences Value Accelerators:

When does 1 + 1 equal more than 2? When you combine best practices, deep industry expertise, and proven processes, tools and techniques. Clarkston’s key differentiator when it comes to accelerating SAP projects for Life Sciences companies is that we have the tactical tools and accelerators to deliver measurable business value while meeting the compliance requirements of various agencies. Key highlights include:

• SAP Best Practices for Life Sciences (accelerators in the form of pre-configured processes and functionality)
• Clarkston experience and knowledge of the industry (our success accelerators)
• Formal Blueprint phase – proven over time – combined with rapid prototype, focusing in fit-gap analysis while identifying client business requirements
• GAMP 5 risk-based approach to deliver compliant GxP computerized system
• A delivery framework based on the use of industry-proven reusable templates and deliverables (our project accelerators)

 

The result? A faster implementation that still meets the client’s objectives. In our experience, we’ve seen implementation timelines reduced by 24% to 40%.
By leveraging the synergies of best-of-breed implementation experiences, we’re applying a synergistic and complementing approach. The fusion of those two distinct sets of experiences is a winning proposition that we bring to the table.

 

Solution Accelerators:

SAP Best Practices, SAP Best Practices for Pharmaceuticals

 

Success Accelerators:

• Team members with both deep Life Sciences and SAP expertise
• Proven effective and flexible methodology, tailored to the size and needs of the client
• Strong program, project, and change management capabilities
• Executive commitment and involvement

 

Project Accelerators – Reusable Templates and Deliverables, including:

• Project Plans
• Issue and Risk Management Plans
• Project Control Templates and Dashboards
• Vendor Audits
• 21 CFR Part 11 Assessments
• Business Process Design Docs and  Process Flows
• cGMP Risk Assessments
• Validation Plans
• Project Team Training Materials
• Design and Functional Requirement Specifications
• Qualifications and Protocols (IQ, OQ, and PQ)
• Test Scripts
• Data Management Strategy
• Data Verification Protocol
• Change Management Plans and Deliverables
• End User Training Plans and Materials
• Security Profile Templates
• SOX Controls
• Post Go-Live Support Strategy

 

Computer Systems Validation Accelerator Toolkit

The U.S. Food and Drug Administration requires Life Sciences companies using computer systems in the development and manufacturing of regulated products to validate those computer systems to ensure accuracy, reliability, and consistent intended performance. Creating a state of sustainable compliance with FDA regulations, including 21 CFR Part 11, Electronic Records; and Electronic Signatures is crucial to the success of Clarkston Consulting’s Life Sciences clients. The Computerized System Validation Methodology guides “how” to conduct computer system validation within the context of Coherent Speed. This Validation Methodology follows FDA guidelines and best industry practices in defining the activities undertaken to validate computerized systems. Besides documenting the validation processes, the methodology includes an Accelerator toolkit – tools, templates, and examples to aid in the delivery of this important service to our clients. Examples include:

• Validation Master Plan Template
• Vendor Audit
• 21 CFR Part 11 Assessment
• Security Plan
• Configuration Management Plan
• Data Migration Plan
• Validation SOPs
• CCRA (Compliance Criticality Risk Assessment) Template
• Design and Function Specification Templates
• Traceability Matrix Template
• User Requirements Template
• Installation Qualification Protocol Template
• Operational Qualification Protocol Template
• Performance Qualification Protocol Template
• Test Plan Templates
• Validation Final Report Templates