Navigating the Regulatory Landscape for Computer Systems Validation

The regulatory landscape is dynamic in nature, constantly evolving and changing at an accelerated pace. Keeping up with changing regulations can be an uphill task for organizations in highly controlled industries. EngiLifeSciences is committed to unraveling the complexity of regulatory compliance in the life sciences industry. Our mission is to help enterprises manage and navigate the global regulatory compliance landscape for Computer Systems Validation (FDA, EMEA, Health Care Canada, etc.) and deliver the most advanced approaches to drive faster, leaner effective compliance.

Download the Guide: Delivering Managed Computer Systems Validation Solutions

This guide explains the process of how EngiLifeSciences delivers leading approaches for Computer Systems Validation by creating more streamlined and effective processes which drive faster, leaner compliance by using their proprietary 3P0 Model Framework.

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How We Accomplish this for Our Clients

EngiLifeSciences participates in industry initiatives regarding Computer Systems Validation, stays up-to-date in the regulated environment, and masters upcoming challenges as technology advances. For example, we participate with the universities, FDA and Industry representatives across the globe working through the challenges of Artificial Intelligence within the regulated environment. Develop leading approaches for Computer Systems Validation in creating more streamlined and effective processes which drive faster, leaner compliance.

Our unique 3PO Model Utilizes Six Principles and Goals to Ensure the Success of Our Managed Computer Systems Validation Services

  1. Well defined life cycle framework
    Goal: Use a well-defined and integrated framework that drives the Who, When and How. This establishes a cost-effective framework.
  2. Process Standardization
    Goal: Standardize processes in an executable form that define the When & How.
  3. Risk-Based Approach
    Goal: Integrate a risk-based approach strategy throughout the life cycle.
  4. Process Scalability
    Goal: Ability to scale the validation deliverables based upon the risk and complexity of the system.
  5. Non Value Add Removal
    Goal: Reduce costs, improve cycle time, obtain increased production and a decreased footprint.
  6. Technology
    Goal: Use data to learn, react and improve product quality, control, error proofing, and increased visibility.

Managed Services Audit Support

When a client engages EngiLifeSciences™, they are enlisting computer systems validation industry experts. Our managed services with our proven processes provide sufficient, objective evidence to demonstrate regulatory compliance. If the regulatory body challenges any of the computer systems evidence compiled by EngiLifeSciences™ during an audit, we stand behind our work and will defend it in support of our client. We will provide timely, quality response to audit requests. All pertinent documentation is readily available and objective evidence is supported. We will explain and support the computer systems validation efforts performed.