Project Management
We provide project management services to clients with proven methodologies that drive structured support when implementing or migrating software. Our approach is employed to execute complex, large-scale projects with ease. We employ tools that drive successful completion of projects that include:
Activity and resource planning
Organizing, mentoring and motivating project team
Monitoring time management
Cost-efficient and effect estimating during budget development
Ensuring customer satisfaction
Quality
We lead with the mindset of promoting, supporting and facilitating proactive quality through the identification and management of risks and implementation of quality improvement activities. We work with your organization identifying quality metrics to ensure that you are inspection ready whether you are starting at the design stage or have finished product. Our overall goal is helping you achieve and improve overall compliance with regulatory requirements and industry best practices.
Validation Strategy and Services
We apply a comprehensive approach when implementing a computer system validation package that complies with FDA, EU, and industry best practices.
Provide a Risk-Based approach to all related validation activities
Offer a standard suite of validation templates, (i.e., System/User Requirements, Validation Plan, Test Protocols, Requirements Traceability Matrix and Validation Report)
Adapt the SOPs to integrate with your existing SDLC and Quality Management System
Train staff in the use of the applicable quality SOPs and Validation Templates
Ensure knowledge centered support is provided throughout the project lifecycle