Validation and Qualification

Validation provides documented evidence that provides a high degree of assurance that computerized systems have been installed correctly and reliably and can perform their functions for their intended use. Medical device validation refers to the process of verifying that a medical item, program, or software works as intended. Validation is necessary to ensure that each device is safe for use and operates correctly for all patients, leaving no room for error or harm.

Software Verification

The purpose of Software Validation is not just to prove that the software can do what you want; To detect and mitigate problems that may negatively impact the production of regulated products and ingredients.

How to Verify Software?

Software Validation is done in 4 stages. These;

Design Qualification
Installation Qualification
Operational Competence
Performance Qualification

To briefly explain the implementation or implementation of Software Validation, first of all, a Validation Plan is made. In this plan, the documents and descriptions of the software system, the environment in which it will be installed, who will be in the validation team and their responsibilities are determined.

Then system requirements are determined. At this stage, the necessary conditions for the software to work in line with your expectations should be outlined.

In the next step, the Verification Protocol and test specifications are created. At this stage, the requirements that the software is expected to meet and evidence that the software is working properly are summarized and test plans are created.

In the final stage, tests are performed and documented. All data, such as positive results of the tests, errors and malfunctions encountered, should be documented at this stage.

What Does Software Verification Do?

Software Verification;

For a constantly improving product and system quality,

In order to ensure compliance with the legislation,

To increase the probability of completing projects on time and within the determined budget limits,

In order for the management to clearly understand the current risks and take the necessary actions correctly,

It is of critical importance in matters such as reducing costs by early detection of errors in pre-production processes.

Medical Devices Institute CONVAL Group, an industry leader specializing in verification services and software testing in line with regulatory requirements and a valuable part of the Excopan Ecosystem, supports its customers in the verification process of systems/software in compliance with the relevant authorities.

Software Verification Standards

Some of the software verification standards are;

EN ISO 13485:2016

IEC 62304:2006+AMD1:2015

IEC/TR 80002-1:2009

ISO TR 80002-2:2017

IEC TR 80002-3:2014

IEC 82304-1:2016

FDA 21 CFR Part 11

GMP

Process Verification

Process Validation is a formal methodology that companies use to produce products through a defined process, resulting in products that consistently meet their specifications and quality requirements.

The scale-up procedure of a medical device product is done using Design Control and Design Reviews at various points to evaluate the design requirements. This helps ensure that the product is on track to meet its specifications. Design Controls require documentation detailing device validation for safety and effectiveness. It should include user requirements specification, design and development planning, risk assessment, and design verification.

In partnership with EXCOPAN, CONVAL Group offers its customers approved production processes, all elements of which comply with regulations, to minimize business risk and increase market competition.

Device description and characteristics, including variants and accessories (Regulation (EU) 2017/746 (IVDR), Annex II Part 1)

Design and manufacturing information (Regulation (EU) 2017/746 (IVDR), Annex II Part 3)

Benefit-Risk Analysis and Risk Management (Regulation (EU) 2017/746 (IVDR), Annex II Parts 5 and 6)

Information provided by the manufacturer (Regulation (EU) 2017/746 (IVDR), Annex II Part 2)

General Safety and Performance Requirements (Regulation (EU) 2017/746 (IVDR), Annex II Part 4)

Summary of Safety and Performance (SSP) (class C and D devices only) (Regulation (EU) 2017/746 (IVDR), Article 29)

Equipment Approval

Equipment qualification is a necessary and critical step in ensuring that a product or service is provided accurately and consistently with requirements consistent with medical device manufacturing and testing. This is especially critical for the medical device industry because the medical device produced by a company is also considered a piece of equipment and requires as much qualification as other equipment and tools involved in manufacturing. Verifying prerequisites prior to qualification ensures a safe and hassle-free qualification process. A prerequisite for equipment qualification is a documented verification aimed at showing that everything is in order before starting the execution of the qualification part.

For medical device companies, using prerequisites means less time spent on avoidable delays and more time spent. Because requirements for a piece of equipment or a device can vary widely from company to company, even between parts of the same type of equipment, it is important to design a universal set of prerequisites that will address all potential problem areas.

Prerequisites in the Equipment Qualification Protocol

Installing equipment in a medical device manufacturing facility involves ensuring that the equipment operates safely and consistently as intended. To do this, it is necessary to verify the following actions:

The equipment has been installed according to the manufacturer's instructions.

The equipment performs within the requirements established by the facility.

Equipment qualifications are generally organized by dividing the protocol into three parts: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Smooth and consistent operation of equipment.

In partnership with EXCOPAN , CONVAL Group provides support in meeting all qualification requirements of your existing and/or new equipment, as well as in the design, design review, selection and installation of new equipment.

Transportation Approval

Transportation verifications are performed to examine the suitability of packaging compatibility and security. Transport and storage should not affect the properties of the medical device; that is, the device must be undamaged, maintain its sterility, be free of physical damage, be free of biological contamination, and function as intended. In transportation validation testing, the medical device package is subjected to various simulated environmental conditions to check whether it withstands the device's specifications without any damage.

The new EU MDR requirements are listed below:

MDR annex I general safety and performance requirements (GSPR) specify the transport and storage requirements for medical devices. The requirements can be summarized as follows;

The device will be packaged in a way that its properties and performance during its intended use will not be adversely affected during transportation and storage.

A device with a specific microbial state is packaged to ensure that it remains in that state when placed on the market and remains that way under transport and storage conditions.

The package will ensure that the sterile condition is maintained until the package is broken.

What Does Transport Validation Involve?

Input data for the design of the transportation validation project plan includes product label claims, existing stability data, and existing processes and systems. In cases where such data is not (yet) available, the verification project plan supports bracketing the required data.

Simulating conveyor belts at laboratory scale can significantly reduce real-life testing.

Base drop testing, vibration testing, shock impact testing, and accelerated environmental testing with UV radiation and temperature cycles under different humidity regimes can simulate real conditions as closely as possible. Results from these laboratory tests provide input into design and real-world proficiency testing.

Transport Verification Stages

The design phase of the transportation verification project plan covers three elements: content, access, and tools.

Contents

Content refers to the type of product transported; i.e. bulk product, intermediate product, unlabeled finished product, labeled finished product.

What is the in-transit exposure to content covered by the plan? Consider not only the way it is packaged, but also the bulk packaging (box packaging, carriers, pallet load), both primary (in contact with the product) and secondary.

Factors that need to be considered and evaluated together with the risk profile for transportation are contact, vibration, temperature, humidity, handling and other possible criteria.

Reach includes the farthest distance the product will be transported. Will it be nationwide (local), regional (EU, US, Asia) or worldwide and will it involve single or multiple transport routes?

Vehicles

Vehicles include modes of transportation that may vary by road, car or truck, and train, sea, and air.

In general, a combination of road, sea and air may need to be considered. Consider the most challenging vehicles or combinations of vehicles for the vehicles in the plan, the quality of roads, vehicles, handovers and more.

Vehicles or multiple vehicles have a direct impact on the transport packaging and this is necessary to prevent a negative impact on the protected product. For example, rough handling, substandard trucks, or exposure to extreme temperatures are just some of the methods that must be considered when testing packaging and packaged product.