Validation is a necessary alternative to inspections and testing when creating software and physical products that would be destroyed or damaged by standard testing. For medical technology and software, process validation is required by the FDA.
In this article, we’ll look at what process validation is and the four steps needed to complete it in order to satisfy regulatory requirements. We’ll also look at how the process differs for software validation and computer systems validation.
What Is Process Validation?
Process validation is the collection and evaluation of data starting from the installation stage through production. For med tech, specifically, the FDA defines process validation as:
[E]stablishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
The FDA requires validation when the results of a process cannot be fully verified by inspection and test. This includes sterilization processes, sterile packaging sealing processes, heat treating processes, plating processes, and plastic injection molding processes. Even when the output of a process can be easily verified, validation is still required for the software used to drive that process. Additionally, validation may be used when verification alone is not enough to eliminate unacceptable risk or is not a cost-effective solution.
The 4 Stages of Process Validation
Completing process validation requires carrying out and documenting qualifications on installation, operation, and performance. These three steps must be done in order and must be followed by the fourth step of creating a final report for the FDA.
Installation qualification is used to verify that the installation of instruments or equipment used to create medical technology is done to the specifications of the manufacturer.
The GHTF defines installation qualification (IQ) as:
Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.
In other words, this step answers the question, “Are the tools we’re using to create our technology installed correctly?”
Important considerations for this step, according to GHTF, are:
- Equipment design features
- Installation conditions
- Calibration, preventative maintenance, cleaning schedules
- Safety features
- Supplier documentation, prints, drawings and manuals
- Software documentation
- Spare parts list
- Environmental conditions
Equipment suppliers may conduct their own validation studies prior to shipping instruments. Documentation for these processes must be included in your IQ. But these documents are insufficient for deciding whether the equipment is suitable for your needs and for the manufacture and development of your product. This is why additional testing and validation must be conducted in-house.
Operational qualification is done during operation to determine process control limits, action levels, potential failure modes, and worst-case scenarios.
The GHTF defines operational qualification (OQ) as:
Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.
OQ asks the question, “Is everything operating the way it should be and what are our operating limits with this device?”
Important considerations for this step, according to GHTF, include:
- Process control limits
- Software parameters
- Raw material specifications
- Process operating procedures
- Material handling requirements
- Process change control
- Short-term stability and capability of the process
- Potential failure modes, action levels, and worst-case conditions
In this phase, according to the GHTF QMS, process parameters should be challenged. The goal is to ensure that the resulting product will meet all specified parameters under all anticipated conditions of manufacturing.
Performance qualification is done to demonstrate that the process will produce consistently acceptable results under normal operating conditions.
The GHTF defines performance qualification (PQ) as:
Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.
PQ asks the question, “Does the process consistently produce the intended result and is that result safe?”
Important considerations for this step, according to GHTF, include:
- Actual product and process parameters and procedures established in OQ
- Acceptability of the product
- Assurance of process capability as established in OQ
- Process repeatability, long-term process stability
Challenges during this step should include conditions established in the OQ phase. In order for the results of these challenges to be meaningful, they must be repeated enough times to ensure consistent results. Meaningful challenges are meant to mimic the conditions that will be encountered during actual manufacturing. Together with the outputs from OQ, PQ will provide attributes for continual monitoring and maintenance of the production system.
Creating the Final Report
Once Installation qualification, operation qualification, and performance qualification have been completed, a final report needs to be prepared. This report should include:
- A summary of all protocols and results
- A reference for documentation confirming results
- Conclusions regarding the validation status of the process
Software Validation vs Computer System Validation
The same steps for validating physical processes for medical technology manufacturers are also needed for the software tools you use to create your devices and SaMD. This includes software tools used to bring your product to market and used after launch to keep your device compliant.
Software validation is included in computer systems validation, another requirement of many regulating bodies including the FDA.
What is CSV?
CSV is a regulatory exercise medical technology companies have long been required to complete. These audits are mandatory for the validation of medical device software and software systems that are used to design, develop, or manufacture medical technology.
According to the FDA’s Title 21 C.F.R. 820.70(i):
When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.
This guidance goes on to describe how provisions of ISO13485 (quality management system guidance) apply to computer systems. It also details how the agency evaluates and validates software systems.
Failure to conform with FDA CSV requirements will result in warning letters and can end with regulatory action.
Just as with validation processes for manufacturing, it is vital that medical technology companies take the time to complete IQ, OQ, and PQ processes for SaMD and computer systems used in and to create medical devices.
Simplify the Validation Process
The validation process required for manufacturing physical medical devices is substantial. But device manufacturers are often familiar with the process, making it easier to complete. What is usually less familiar is the process of validating software components and computer systems. This is where an experienced partner can help save you time and money and prevent problems with regulatory agencies.
Here at Sequenex, we specialize in developing software for use in the diabetes medical technology field. We have decades of experience working with regulatory agencies to validate software and software systems used in this market. Our proven processes for software testing are guaranteed to simplify CSV and process validation to save you time and money and get your product to market sooner. Contact us today to find out more.