GAMP & GxP Validation

Introduction

viewLinc is ideal for GxP/FDA-regulated applications and environments that contain high-value products. If you are required to maintain compliant environmental monitoring methods and documentation, we recommend you validate your viewLinc monitoring system.  A GxP-compliant Installation Qualification and Operation Qualification protocol document (view sample) is available from Vaisala. This IQOQ document is based on best practices in software validation outlined by regulatory bodies and GAMP5 principles. The documents ensure your system is installed correctly and will perform as expected. Ideally, IQOQ testing is performed by a qualified technician from your firm. Alternatively, you can have your system validation performed by Vaisala's skilled Field Services technicians.

Validation & Compliance Products for Life Science

System validation is essential in pharmaceutical, biological and medical device manufacturing and distribution. In terms of environmental monitoring applications, a poorly executed validation is a risk to the quality of your monitoring software implementation.  Not only does validation prove that your monitoring system is fit for its intended use, it helps fulfill the ultimate goal of protecting consumers by ensuring product quality. Additionally, an inadequately qualified monitoring system will result in unwanted observations at inspection time and uncomfortable questions during customer audits.

To ensure that your implementation of the Vaisala viewLinc monitoring software complies with Good Manufacturing Practice (GMP), we recommend using the ISPE Good Automated Manufacturing Practice (GAMP) methodology for system validation as guide to ensure your monitoring system software performs as expected and helps you achieve compliance. GAMP provides a risk-based approach to the deployment and maintenance of GxP-compliant computerized systems using pragmatic and practical industry guidance to ensure your system performs effectively.

Vaisala simplifies your compliance efforts with validation products and services that will speed and simplify the implementation of your monitoring system. We offer a comprehensive set of validation protocols designed to help you integrate your viewLinc monitoring system into your Quality Management System. These protocols comprise standard processes for system qualification and documented evidence of control to your auditors. Whether you choose to validate your system in-house, or use the service, the viewLinc Installation Qualification and Operation Qualification (IQOQ) protocols will help you meet regulatory requirements. We also offer validation as a service in many regions.

Contact your local representative to learn if we offer validation service in your area.

A GAMP-Based Approach to Environmental Monitoring Systems for GxP Applications

The International Society for Pharmaceutical Engineering is the world's largest not-for-profit association serving the scientific, technical, and regulatory professions in life sciences and pharmaceutical development, manufacturing and distribution. The ISPE’s technical subcommittee for Good automated manufacturing practice (GAMP) has created a set of guidelines that are designed to help professionals in the pharmaceutical use automated systems in ways that comply with international standards and regulations. In GAMP guidance there is a basic assumption that testing alone cannot create quality.  

Quality must be built into a system from design onwards. With automated system design based on product quality as the primary objective, the GAMP approach helps ensure that systems are fit for use in GxP-regulated environments. This implies that, once automated systems are designed for use in GxP applications, they are then implemented in a controlled manner. Controlling system deployment contains steps for system verification. Another primary concept within GAMP is to leverage supplier involvement. As the system expert, the vendor has often has already done much of the required testing. Typically testing follows this general framework: specification, implementation and verification.

Specify, Implement, Verify

Specify

1) The system is specified based on the needs of the customer.
2) The system is then built and implemented based on the customer specifications.
3) Then verification takes place to make sure that the implemented system matches the original specifications.


First, Specify.  This is achieved with documents called “Specifications.” The three specifications listed here are the usual documents seen in a GAMP approach:

  • URS: User Requirements Specification
    • What the user needs the system to do. “The system must move a 1m3 box from Location 1 to Location 2.”
  • FS: Functional Specification
    • The functions of the system that will fulfill the users’ needs. “The system will move a 1m3 box on a rolling platform.”
  • DS: Design Specification
    • How the system will be designed to provide the functions. “We will build a 120cm x 120cm cart with four 100mm wheels.”

The Design element creates the function and the function fulfills the requirement. These documents are designed to describe a system before it is built or acquired.  We will see some differences when we apply this model to products like Vaisala’s viewLinc monitoring system, which is already designed and must then be implemented in a GAMP approach.

Implement
This is the part most of us are familiar with.  It has three typical phases. First, a system is built at a site. For example, Vaisala creates software, sensors and networking equipment. This equipment is delivered to the site it will be used in. Once there, it is installed and configured. Imagine if this was a large and expensive custom-built machine automated with a custom software package.  Every phase of implementation becomes more complicated.  We begin to see why, in this general model, implementation phases are each described separately; because there is a lot of work to do.  Systems must be built to specification and carefully shipped for assembly and installation at the customer site.

Verify
There are several testing phases. First, FAT or Factory Acceptance Testing, ensures that the system has been properly built before it is shipped to the customer.  SAT, or Site Acceptance Testing, is done at the customer’s site to show that the system was received with all its expected parts and configurations, etc.  This may also include commissioning and connection to utilities.

The Installation Qualification and Operational Qualification 
The IQOQ is typically performed after installation to ensure that the system has been installed correctly and is operating correctly.  IQOQ testing is always done to the vendor’s specifications, since they are the system experts. Finally there is the Performance Qualification round of testing to ensure that the system is performing correctly.  PQ Testing is always done to your own specifications to ensure that the system will perform correctly for the system’s intended use in your application.

Monitoring System Implementation with a GAMP Approach

First, the viewLinc system is assembled from existing standard products, such as the viewLinc software and Vaisala data loggers. It is fairly simple in that it doesn’t require detailed development specifically for each application it is used in. Second, viewLinc requires very little in the way of utilities, and this makes the installation easy. One final difference – the viewLinc monitoring system has limited functionality; it monitors, alarms, and reports on a given set of environmental parameters. With no control functions testing and validation of the system is quick and simple.

The System Categories of GAMP

From a GAMP perspective, the basic difference that impacts viewLinc implementation is “System Category.” There are three GAMP categories that apply to an automated monitoring system like viewLinc.  Category 1 and 2 systems refer to firmware and operating systems, neither of which are suitable to function as a continuous monitoring system. But the other categories 3, 4 and 5, do apply to monitoring systems in general. Category 3 refers to “Non-configured” products. These are sometimes called  “Plug and Play.” Category 4 is called “Configured” systems. Category 5 refers to “Custom” systems.

These categories are important to understand because they have a significant effect on the cost of a monitoring system. Category 3 systems require much less work to implement and test than category 5. Category 3 systems are “non-configured” systems.  This means that they should basically work right out of the box without requiring configuration. All categories of systems require some configuration.  This is usually done during automated installation. A very simple configuration involve things like setting up locations for storing data, creating system users, or adding printers to a system.  This is called “run-time” configuration and it is allowed for “non-configured” systems.

viewLinc GxP Documentation package

Based on these processes: specify, implement and verify; Vaisala provides a GxP System Documentation package for the viewLinc monitoring system to ensure the system fulfills the recommendations of GAMP. We offer two specifications: the User Requirements Specifications and Functional Specifications.  We do not have the Configuration Specifications because it would be a custom document, and many viewLinc users find it unnecessary because their configuration requirements are included in their URS. We also offer two documents that are organizational tools within the classic GAMP model.  These are the Traceability Matrix and the Risk Assessment.

The Traceability Matrix is a table that tracks each requirement to make sure that it is fulfilled by a corresponding function, and ensures that each required function is tested. The Risk Assessment document evaluates risk associated with a failure of each required function. This allows us to allocate our efforts toward testing high-risk functions as a priority.  Low-risk functions are not included in the Standard IQOQ, which is the final part of Vaisala’s GxP document package. These documents, the URS, FS, TM, RA and the viewLinc IQOQ, can provide our GxP customers with time and cost saving tools that allow them to run a more monitoring system that follows the GAMP  model for automated systems.

To learn more about our services and products that aid in GxP compliance: