Validation Coaching & Mentoring Services

 

We understand the business imperative to work smarter, not harder. Through ValidationPro℠, we deliver ready-to-work IV&V teams with the requisite practical hands-on knowledge and advanced test automation tools to optimize any type of validation project. Our team consists of a validation project manager, validation systems engineer and a validation test engineer.

The ValidationPro℠ team works closely with your implementation team to ensure a cohesive approach to your project. From beginning to end, we manage your validation project to enable your internal resources to focus on other initiatives that impact your bottom line. Our ValidationPro℠ specialists come from the ranks of leading life sciences organizations. Each expert brings over a decade or more of enterprise validation experience to your project.

ValidationPro℠ professional services are delivered with a straightforward mission – to deliver a fully validated system leveraging a ready-to-work validation team. Our experts will coach your team on validation activities that establish and sustain validated environments while ensuring compliance.

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CONTACT US TODAY ABOUT 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. Contact us today if you have a project in mind. We can help!

Features and Benefits

 

SOP Development Services

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.

 
 

ValidationCoach Master Class

 

Strategy and insights workshop providing in-depth training on validation principles and best practices for cybersecurity qualification, cloud validation, data integrity and much more.d

 

Validation Project Management

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.

 
 

IV&V Coaching & Mentoring 

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.

Validation Assessments

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.

 
 

Cloud Validation Workshop

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.

Validation Test Execution Services

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).

 

Computer Systems Audit

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.

ISPE GAMP 5® Best Practices Workshop

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. 

 
 

Training & Competency Management

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.