GAMP Validation

The Power of GAMP Validation: Simplifying the Process with Automation NTH

Validating an automated system can be a daunting, arduous process. Validation requires meticulous attention to detail, from capturing the documentation, logging revisions, and ensuring every change is validated before acceptance. At Automation NTH, our deep understanding of this complex process allows us to provide our customers with robust automation systems that meets their requirements and inspires absolute confidence.

Automation NTH’s Commitment: Dependable Systems and Streamlined Validation

At Automation NTH, we create advanced, reliable custom automation systems with clean, trackable documentation that accelerates the validation process. Our standard procedures are documented in our Quality Assurance Manual (QAM) and are complemented by our customizable “ala carte” validation options. This approach enables our experienced Validation Resources to seamlessly augment the customer’s existing validation resources.

During the proposal phase, we facilitate an open dialogue between Automation NTH’s Engineers and the customer’s Validation Engineers. This conversation helps define the level of detail needed for the specific application, resulting in a more accurate validation scope and quotation. We offer tailored documentation packages according to the level of validation needed by each customer.

Beginning with the End in Mind: The Kickoff Validation Meeting

We believe in the importance of a comprehensive validation overview at the beginning of a project. Our Kickoff Validation Meeting enables us to strategize from a cradle-to-grave perspective. Our Quality and Technical Writing Departments are dedicated to maintaining up-to-date documentation that adheres to the GAMP5 model.

We create a Compliance Matrix based on the customer-provided User Requirement Specification (URS). Alongside our proposal, this matrix guides the development of a Functional Design Specification (FDS), which details how the mechanical and electrical designs respond to each requirement from the Compliance Matrix.

Additionally, we offer a Quality Assurance Plan (QAPP) as one of our tailored offerings. The QAPP documents the validation options purchased by the customer, outlining the deliverables for each selected option.

Ensuring Reliable Code Structure and Integration

Throughout the software development process, our goal is to create a modular, testable code structure for our customers. Our engineers diligently verify their work during the design and debug phase, ensuring that the resulting code is not just functional, but reliable with expected sequencing.

This rigorous approach leads to the creation of robust, reliable code that can be tested both internally and by the customer, facilitating efficient and confident conduction of requirement tests.

Traceability Matrix example GAMP validation
Traceability Matrix Example

To keep all parties on track, we utlize a Software Design Specification (SDS) that functions as a roadmap for customers and a benchmark for our engineers. Similarly, our Hardware Design Specifications (HDS) captures the integration of software and hardware, providing a shared roadmap for our processes. To keep track of requirement fulfillment, a Trace Matrix links our Compliance Matrix with Design Specification documents.

IQ protocol example GAMP Validation
Example IQ Test

Delivering Comprehensive GAMP Documentation and Support

To provide a complete support system for customers, our GAMP documentation package includes an Installation Qualification (IQ) Test Plan and Protocol, as well as an Operation Qualification (OQ) Test Plan and Protocol. Automation NTH oversees the execution of these plans, ensuring that they are completed efficiently and with excellence.

Automation NTH: Your Partner in GAMP Validation

As a dedicated partner, Automation NTH is committed to delivering fully FDA validated systems that reduce project timelines. We understand that validation can be a challenging endeavor, but with Automation NTH’s support, customers can trust in the robustness, efficiency, and reliability of their automation equipment.

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