Updated on April 13, 2020 by Rick Emlet
In the highly regulated pharmaceutical and life sciences industries, even small variances can cause damaging repercussions. This is why the FDA robustly enforces the qualification measures and strict validation processes specified in the CFR.
To obtain FDA approval or pass an audit, one of the first steps that regulated companies must complete is equipment validation. The protocol is divided into three main parts: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). These are key components to quality assurance and producing consistent, quality products.
Outer Edge routinely provides all the evidence that companies need to complete the IQ portion of the validation process. But it can be a confusing subject. So, let’s take a closer look at IQ validation, the importance of validation documentation, and the process as it applies to virtual and cloud servers.
What Is IQ Validation?
IQ validation, or installation verification testing, is a very specific component of any validation process for both on-premises and cloud environments on which servers and computer equipment are running. IQ verifies the infrastructure build which should follow the technical requirements document of the installed application. Then, OQ checks that software will function according to its operational specifications in a particular environment, and PQ ensures that software performs to specifications during routine use.
Installation qualification serves to authenticate that all instruments (including sub-systems and any ancillary systems) affecting product quality comply with approved specifications. These specifications including equipment:
- Design,
- Delivery
- Configuration, and
- Installation.
As the first step of the qualification process for new and modified equipment, the IQ checklist covers the entire IT infrastructure, such as:
- Hardware,
- Operating system,
- Firmware versions and serial numbers,
- Environmental and operating conditions,
- Software system installation and configuration,
- Connections and communication with peripheral units,
- CPU, memory, and storage capacity,
- Network configuration.
Why Is IQ Validation Evidence Important?
In short, IQ is an important part of the validation process for the components that an environment is running on. When applied to both physical and software testing, the FDA states that the overall objective is substantiating that the “system has the necessary prerequisite conditions to function as expected.”
Evidence for IQ validation is detailed documentation of what the infrastructure environment looks like. Validation companies use this evidence in audits to confirm the technical specifications of the infrastructure. The FDA is one example of a governing body which requires evidence of IQ validation for compliance and auditing purposes.
Compliance with Federal Regulations
IQ validation is one of the building blocks for compliance with the requirements and controls that have been put in place to ensure drug safety. This is because computer systems are at the foundation of the processes and procedures which work to eliminate variance in pharmaceutical manufacturing. Quality assurance is managed, on a very real level, by computer systems from production, all the way to delivery of each drug.
Customer Assurance
In addition to ensuring FDA compliance, IQ validation serves as proof for companies that their provider has built the IT infrastructure which they requested. In this sense, it is customer assurance that they’re getting what they paid for. Once the system has been validated, the company is provided documentation which is essentially a blueprint of the infrastructure’s components, configuration, and network design.
Facilitating Maintenance & Repairs
The majority of businesses operating outside of FDA-controlled industries are not required to document their servers or have access to any of this information. But without the blueprint, technicians don’t know what they’re working with. They are lost when it’s time to intervene in the IT environment.
IQ validation documentation provides the information they need to quickly troubleshoot and fix problems on the server. It also helps with server licensing, relicensing, and IT budgeting. These are just some of the reasons why we think that it’s a best practice for businesses to have a documented account of what they actually have in their system.
What Types of Servers Can Pass IQ Validation?
We have received a lot of questions from pharmaceutical companies about the possibility of using cloud servers, such as Amazon or Azure. The good news is that it’s possible to get validation evidence for any type of environment— regardless of whether the server is dedicated, virtual, in the cloud or locally hosted. The process is not any more complicated for one type of server and evidence for FDA compliance is just as effective.
A common misconception is about the need to use a physical server or dedicated blade server within the cloud. Though using a dedicated physical instance is an option, it’s a very expensive one, costing several times more than using a virtual instance. It’s not necessary to have a dedicated physical server to attain IQ validation.
The truth is that you can get validation from a virtual server. The requirements and process for validation are the same, even for cloud servers. The only difference is that documentation evidence would validate the virtual server, rather than the physical components of a server. From cost savings to significant performance gains, hosting applications in the cloud offers significant advantages to life science and pharma companies over traditional, locally hosted servers.
Related article: How Cloud Validation Simplifies Compliance for Life Sciences Industry.
How Long Does IQ Validation Last?
IQ validation evidence is a living document which is connected to change control and it must be kept up to date. It is inevitable that the IT environment will change over time. Some changes aren’t significant, while others will necessitate revalidation.
Who Is Responsible for IQ Validation Documentation?
It is the role of managed service providers (MSP) and cloud service providers to provide and maintain documentation related to evidence provided for the IQ validation. They are the best equipped to collect and update this information as the environments they manage may change over time.
Related article: Why Life Sciences Companies Leverage Managed Regulated Infrastructures to Smooth the Path to FDA Approval.
We Provide Evidence for IQ Validation
Are you unsure of what kind of documentation you need for IQ validation? Confused about how to provide the documentation required to comply with this step in the FDA-approval process? Outer Edge routinely supplies companies with reports on existing infrastructures required for successful IQ validation.
Outer Edge often designs new IT environments to satisfy its customers requirements and FDA regulations.Then, we deliver a turnkey solution with all the detailed information your business needs for this part of the FDA validation process. Contact Outer Edge today to get your questions answered: call 844-OET-EDGE or send us an email.
