When implementing an Electronic Quality Management System Software (eQMS) in your Medical Device or Pharmaceutical company, this software in many cases needs to be validated. Therefore, you need to make sure that your system is working and meets its intended use.

In this article, we will cover typical eQMS processes that either need or do not need software validation. We will also discuss various regulations and standards that dictate requirements to validate your eQMS. Besides that, touch upon how QMS software validation is done.

What Is QMS Software Validation?

Software validation is a method used to secure that the processes performed by automated software work as expected. Software validation, in this case for Electronic Quality Management Systems, is achieved through a set of planned activities that are conducted throughout various stages of the software development and implementation stages. Simply put, eQMS Software validation establishes a level of confidence in the application’s ability to meet its intended use.

Activities within the eQMS validation process vary, depending on the sophistication of the software itself. Also, the amount of information from the vendor of the software and the risk of harm. Every organization must carefully consider the effect of implementing and validating eQMS software, especially if it is going to be a part of the enterprise’s critical operations.

Within the Life Science industry, companies must demonstrate full compliance with the applicable regulations and various standards. For this reason, once the new Electronic Quality Management System is launched, it is crucial that is monitored regularly, to ensure that the system is working as intended.

When Is It Necessary to Validate QMS Software?

Many Life Science companies are required to comply with one or more regulations and standards, which require QMS software validation. One of the regulations that apply to many pharmaceutical, biotech, and medical device companies is FDA 21 CFR Part 11.

21 CFR Part 11 applies whenever information is to be electronically generated, amended, stored, transferred, or accessed. This can involve different types of information, such as text, drawings, images, or videos.

Within 21 CFR Part 11 Section 11.10 (Controls for closed systems) the need for validation of quality systems is outlined as follows:

“(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

In the medical device industry, the requirement for QMS software validation is specifically mentioned in ISO13485:2016 and FDA 21 CFR Part 820.

ISO13485:2016 within Section 4.1.6 (General requirements) outlines the quality management system validation as follows:

“The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and as appropriate, after changes to such software or its application.

The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.

Records of such activities shall be maintained (see 4.2.5)”

21 CFR 820.70 describes quality system validation as follows:

“(i) Automated processes. 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.”

Furthermore, eQMS software must be validated if a system is used in good practice (GxP) processes. Especially when collecting the necessary information for the regulatory bodies, as well as revising the quality of a product.

Scope of QMS Software Validation

The scope of validation includes the following examples of documents, records, and processes.

Production Management

The scope of QMS software validation includes tools connected to:

  • Production equipment
  • Control equipment
  • Measuring equipment

As well as Computer-Aided Production Management (CAPM) tool which contains:

  • Production routings
  • Inspection plans
  • Production records
  • Inspections records

Document Management

The scope of QMS software validation concerning documents management tools include:

  • Document Management Tools
  • Spreadsheets containing quality management records, like Corrective and Preventive Actions (CAPAs)
  • Documents such as Standard Operating Procedures (SOPs), Controlled Templates, Training Certificates, Regulatory Certificates, etc.

Support Management

  • Support management tools managing:
  • Customer complaints
  • Support tickets
  • Requests
  • Software bugs

Maintenance Management

Software tools that manage:

  • Service reporting
  • Remote access to documentation
  • Backup and recovery tools

Thankfully, the scope of validation does not include all software applications used by a Life Science product manufacturer.

These are the software tools with no mandatory validation requirements:

  • Non-QMS related financial and administrative software
  • Suite software, without macros related to the QMS
  • Network tools and mailing systems
  • Server tools
  • Operating systems

How Is QMS Software Validated

The main goal of QMS software validation is to establish a level of confidence that the software is trustworthy, reliable, and appropriate for its intended use.

These are the primary steps which prove that QMS Software is properly installed and validated:

1. Perform a Risk Analysis

When developing a validation procedure, you want to adopt a risk-based approach. One that evaluates the current, updated, and new software that will be used in the Quality Management System.

To understand whether you should validate you want to evaluate the risks associated with the use of the QMS software. For this purpose, GAMP 5 is an excellent, and slightly comprehensive, a guide to “A Risk-Based Approach to Compliant GxP Computerized Systems”.

Furthermore, we suggest that you assemble a team that will verify the degree of risks of all the pieces of software that are related to QMS processes.

2. Establish Validation Procedures and Templates

Further on, you need to establish the necessary validation procedures and templates. At this stage, it is useful to collect relevant release notes, validation, and verification documents from your software vendors. All of those will support your validation activities. Moreover, create a list of your requirements for those software tools.

3. Document the Installation and Testing of the System

Define the requirements for this software and define how these requirements should be tested.

Then you can execute tests while documenting the results, as well as coming up with the conclusions for each testing phase:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Process Qualification (PQ)

Document testing results and defines when testing should be conducted again. A validation procedure should arise from this process.

4. Develop a Training Plan and Training Records

At this stage of the validation process, you will need to develop training plans and training records for different kinds of software users. Thus, the training activities must be carefully planned to secure a successful implementation, maintenance, and operation of the eQMS. The type and extent of training shall be based on the role and responsibility of each eQMS user group.

5. Transition from Planning to Execution

After that, it is time to transition from the old system to the new system.

6. Develop Change Management Procedures

Lastly, you must define at what point it is necessary to go through the validation process again if too many changes have been made. Therefore, you must ensure that the system changes and updates are handled in a controlled way. This requires creating and documenting procedures that describe the above.

Watch the video on how to validate an eQMS to learn more about this subject.

Benefits of Validated QMS Software

However, QMS Software validation should not only be interpreted as a mandatory task without any benefits. Here are some of the benefits your Life Science organization will come across when validating your QMS software.

High Level of Security

Validation of QMS software ensures that the security of your electronic systems and data is intact, something which is increasingly important.

Thorough & Continuous Testing

With validated QMS software, your organization’s critical systems are thoroughly and repeatedly tested.

High-Quality Risk Analysis

Every time you do the whole validation process you can consider the risk of changes carefully before implementing them.

Pre-Validated QMS Software

QMS Software Validation – you can either do it yourself, with help of your vendor, or buy a pre-validated and certified eQMS solution like SimplerQMS.

Moreover, without pre-validated QMS software will need to manually test whether the software is working as intended and possibly hire staff that is qualified to do the testing.

Furthermore, if you make changes to your quality management system software after the initial testing you will have to repeat that process. On the other hand, pre-validated QMS software does it automatically and provides a much faster and smoother implementation.

Final Thoughts

Software validation ensures that the processes performed by automated software system work as initially intended. Most companies within the Life Science industry must comply with one or more legislations and standards, which call for validated QMS software.

The scope of software validation includes documents, records, and processes related to production, document, support, and maintenance management. On the other hand, the scope of validation does not include software applications related to non-QMS financial and administrative software.

The main objective of QMS software validation is to ensure that the software is trustworthy, reliable, and appropriate for its intended use. Moreover, QMS software validation provides additional benefits like a higher level of security, better-executed risk analysis, and thorough testing, done on an ongoing basis. The good news is that many eQMS software providers, including SimplerQMS, provide a pre-validated solution which makes the total validation process much simpler.