Process Validation Services
How Can We Help?
Most validation problems start well before anyone writes a protocol. They start with a process that was never fully defined, or a decision to validate that was made out of habit instead of risk.
We work with your team to sort out which processes actually need validation, then write the plans, protocols and reports behind that decision.
Our Process
Step
1
Define
The first step is to define the process. Flowcharts are a great tool for this and the actual task of making the flowchart provides a lot of value. You will be surprised how much you learn from the session.
Step
2
Evaluate
The next step is evaluation of the process; we need to decide what steps require validation. We will think through the equipment used, the activities that are performed at each step, facility requirements, and the material inputs and outputs to make this decision.
Step
3
Plan
The next step is to define the validation plan for each item on the flow chart that is identified as needing validation. The output of this phase is the Master Validation Plan and specific validation protocols. This step may include planning equipment IQ/OQ/PQs.
Step
4
EXECUTE
Your team executes the protocols and collects the data. We remain engaged to answer questions as they come up and to handle the deviations and protocol amendments that almost always surface once you get into real runs.
Step
5
Report
The final step in the initial validation is to collate the data and write the validation report. Once the report is signed, then the initial validation is complete. You can now officially say you have a validated process.
Step
6
Revalidate
Over time, you should continue to monitor the process, determine if/when changes should trigger revalidation and when improvements are needed. Routine monitoring is defined in the Master Validation Plan and ad hoc revalidations can be documented in a variety of ways.
What is Process Validation?
Process validation ensures that a process can reliably produce a product. Regulatory authorities like the FDA have rules and guidelines concerning process validation. The goal is to ensure that varied inputs result in consistent and high-quality outputs. It’s an ongoing process that needs frequent adaptation based on manufacturing feedback. End-to-end validation of production processes is crucial for product quality. The FDA discourages relying solely on finished-product inspection, emphasizing that quality should be built into products and processes throughout production, starting at the earliest stage rather than at the end.
When Does a Process Require Validation?
A process must be validated when its output “cannot be verified by subsequent monitoring or measurement,” meaning any defect would surface only after the device is in use. That regulation has since been superseded by the QMSR, which now points to ISO 13485:2016 Clause 7.5.6, but the requirement itself has not changed.
Not every process has to be validated. The manufacturer decides which processes require validation and which can rely on inspection and testing to assure quality. When validation is determined not to be necessary, that rationale should be documented.
Process validation is one of three validation domains ISO 13485 addresses, alongside software validation (Clause 4.1.6) and design validation (Clause 7.3.7). Keeping them distinct matters, because they answer different questions and call for different evidence.
For a practical, freely available framework on the validate-or-not decision, the GHTF Process Validation Guidance (GHTF/SG3/N99-10:2004) remains a widely used reference.
Qualomics can help you with every step of the validation journey from planning to completion.