COACHING & MENTORING SERVICES
Features & Benefits
SOPs are essential for valiation governance. Expert services in the development of validation SOPs that provide governance for the process including cloud and cybersecurity SOPs for validated systems.
Our Validation Coaches have deep validation and project management experience. Through our coaching services we deliver comprehensive IV&V project management services driving your validation projects to a one-time successful conclusion.
Assessments are key to ensure that your systems perform according to their intended use. We offer in-depth assessments for 21 CFR Part 11, EU Annex 11, cGxP, and much more.
As an experienced Validation Coach, we can assist with tactical IV&V activities. Using our advanced automated testing tools, we can assist with the development and execution of validation test scripts including IQ/OQ/PQ and User Acceptance Testing (UAT).
Practical, working session to understand and apply the principles and best practices highlighted within the ISPE GAMP 5 guidance document. Workshop includes templates and expert instruction.
Strategy and insights workshop providing in-depth training on validation principles and best practices for cybersecurity qualification, cloud validation, data integrity and much more.
The learning curve can be steep for new enterprise technologies. ValidationCoach helps accelerate your learning curve by providing strategies, best practices and test scripts to help you validate the latest enterprise systems.
As cloud adoption increases, many are concerned about the impact on software validation activities. This unique training workshop provides the insight you need to succeed.
Independent audit services can provide key insight to your IV&V processes and programs. We conduct various types of audit assessments and provide critical feedback and written audit summaries.
Workshop features the latest training and competency management solutions for life sciences. Presents industry best practices for the automated management and delivery of training records for IV&V projects.
Your Next Validation Project
We specialize in the validation of enterprise technologies such as Microsoft Dynamics 365, Microsoft Azure, SAP, Enterprise Content Management, Enterprise Quality Management and other such systems.