Elements of a Successful Computer Systems Validation Plan

When it comes to your regular day-to-day job, computer system validation is hardly at the top of the list of requirements for lab work.

Yet if your lab is in Manufacturing, Pharma, Biotech, or Healthcare, then you will need to validate your computer systems in order to meet GxP standards (including GMP, GLP, and GCP). This starts with a validation plan: a high-level document outlining the steps taken to validate your systems and software.

In this guide, we’ll share the key elements of a successful validation plan and share resources on how to implement one in your lab.

What is a Validation Plan?

A validation plan is a document that contains high-level planning for the validation of your systems and software. 

It’s easy to let your mind jump to “testing” when you hear the word “validation;” however, the need for a validation plan goes well beyond the tests run in your lab. To meet GxP standards, you will need a validation plan for all systems in your lab, including computerized systems and software. 

A popular standard for labs to follow can be found in the GAMP® 5 guide, which takes a risk-based approach to validation, covering various aspects from an overview of your systems to risk management and SOPs. We’ll cover this in more detail later on.

Why Your Lab Needs a Validation Plan

Any lab in the health industry (pharma, clinical, biotech, medical devices, etc.) is required to establish a validation plan that demonstrates any procedure, process, equipment, material, activity, or system leads to expected results. 

It’s worth noting that many regulatory standards require a validation plan in place for your systems, including the following:

• ISO 17025
• FDA 21 CFR Part 11
• CLIA
• GxP (not a standard per se, but often gets lumped in with the above standards in compliance conversations).

Due to the growing adoption of digital technology by modern labs, computer systems are becoming more important to validate in order to meet these standards. There are a few key reasons that your lab needs a proper validation plan in place, including:

• Regulatory compliance: This is the obvious one; many regulatory bodies (FDA, EPA, ISO) require documented validation
• Quality assurance: If not to meet compliance standards, then for your own sake. A validation plan for your systems and software ensures consistent, high-quality results.
• Risk management: A validation plan helps identify and mitigate potential issues before they affect results.
• Accreditation: If your lab seeks accreditation, then a computer system validation plan may be required.

Now that you know what a validation plan is and why it is needed, let's walk through the elements of a plan and how to create one for your lab.

What Counts as a Computerized System

Clearly, having a validation plan is important to the success of your lab. But what specifically do you need to validate? Computerized systems don’t just cover software, they could be one of the following:

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Whether you use sophisticated software to capture data like a LIMS or more manual methods like Excel, you will need a validation plan in place for these systems.

What Goes Into an Effective Validation Plan

While a validation plan may seem like it has high stakes, it’s quite simple to create one for your lab. 

An effective validation plan will be made up of the following elements:

• Purpose and scope
• Roles and responsibilities
• Validation parameters and acceptance criteria
• Testing procedures
• Documentation requirements
• Training requirements
• Change control procedures
• Maintenance and revalidation schedules

We’ll walk through each of these in more depth next.

Purpose and Scope

Your validation plan must start with a clear purpose and scope section that serves as the foundation for all validation activities. 

This section outlines exactly what is being validated, whether it's a new analytical method, a piece of equipment, or an entire laboratory system. It defines the boundaries of the validation effort, including which departments are affected and what quality attributes must be demonstrated. Most importantly, it connects the validation effort to specific regulatory requirements that the lab must meet.

Roles and Responsibilities

Next, your validation plan must contain well-defined roles and responsibilities. 

A validation team typically includes a project manager or validation lead who oversees the entire process, quality assurance personnel who ensure compliance with standards, and subject matter experts who provide technical expertise. Clear delineation of who has the authority to review and approve various stages of the validation process prevents bottlenecks and ensures accountability throughout the project.

Validation Parameters and Acceptance Criteria

These are the specific measurements and standards that prove the system works as intended. 

For your systems and software, that might include:

• User access control verification
• Data integrity checks
• System interface testing
• Backup and recovery testing

Each parameter must have clear, measurable acceptance criteria that align with the lab's quality requirements and regulatory standards. The criteria should be specific enough to enable objective pass/fail decisions but practical enough to be achievable under normal operating conditions.

Testing Procedures

Testing procedures form the practical framework of the validation process. 

These procedures detail exactly how each validation parameter will be tested, including sampling plans, control sample requirements, and data collection methods. When it comes to computerized systems, the top procedures to bear in mind are:

• Installation Qualification (IQ): Verifies proper system installation.
• Operational Qualification (OQ): Confirms system operates as designed.
• Performance Qualification (PQ): Ensures consistent performance under actual conditions.

Documentation Requirements

Documentation requirements in a validation plan cannot be overstated. 

The old quality adage "if it isn't documented, it didn't happen" is particularly relevant to validation. A complete documentation package includes the validation master plan, standard operating procedures, test protocols and results, raw data records, equipment qualification documents, calibration records, training records, and deviation reports. The final validation report pulls all this documentation together to demonstrate that the validation was successful and complete.

Training Requirements

Training requirements ensure that personnel performing validation activities are competent and qualified. 

Your training program should include both initial and ongoing training, with clear methods for assessing competency. Documentation of training completion and verification of competency are essential parts of the validation record. This extends beyond just the validation period - ongoing training ensures that validated processes are performed correctly.

Change Control Procedures

Change control procedures protect the validated state by managing modifications systematically. 

Any changes to validated systems, whether planned improvements or emergency repairs, must be evaluated for their impact on the validation status. This includes a formal change request process, impact assessment, documentation updates, and procedures for implementing changes. Some changes may trigger partial or complete revalidation, making change control a critical part of maintaining validated status.

Maintenance and Revalidation schedules

This includes routine maintenance requirements, performance monitoring schedules, and criteria for when revalidation is necessary. Periodic reviews ensure that validation remains current and effective. Calibration schedules, software update procedures, and emergency maintenance protocols all play a role in maintaining the validated state of laboratory systems.

How a LIMS Helps in Building and Implementing a Validation Plan

As you can imagine, managing a lab manually through disparate systems exposes you to a world of complexity (and hours of refining, testing, and validating). 

That’s where a Laboratory Information Management System (LIMS) plays a crucial role in supporting and streamlining the validation process. 

A LIMS centralizes all of the data in your lab. By interfacing directly with instruments and integrating with your software, you can bring all of your data under one roof. This drastically simplifies your lab’s processes and reduces the room for any errors or missed steps in your validation plan.

A LIMS like QBench can do much more than that, though. You can:

• Monitor inventory levels and trigger alerts
• Validate data to ensure your lab runs smoothly
• Print and scan barcodes to standardize labels in your lab and reduce errors
• Store SOPs and documents
• Report on user activity through audit trails

And more that can be essential for regulatory compliance.

Ultimately, a LIMS doesn’t just speed up processes for your lab; it improves data integrity through every process. Through data validation, audit trails, regular backups, and more, a LIMS is a major asset for modern labs and can rapidly speed up your process of creating and implementing a successful validation plan.

But only if you select the right LIMS.

Ready for a LIMS? Download the LIMS Buyer’s Guide

While you could manage your lab, run tests, and meet regulatory standards without a LIMS and use disparate systems instead, it’s probably quite clear that this would result in a monumental amount of work. 

A LIMS is a key asset for any modern lab: it automates your workflows and centralizes your data while implementing compliance safeguards and regular backups. In other words, a LIMS won’t automatically make your lab compliant but it makes the process much more efficient.

Only if you choose the right LIMS, though.

Click the button below to download the free LIMS buyer’s guide and take the first step toward improving your lab’s inventory and sample management processes.