Today I would like to provide you with some more information on the topic that I discussed in yesterday's post (Software Validation CFR21 Part 11).
In my opinion it is interesting to give you some details about some of the terms that are in use during a validation. So that we can better understand what a software validation according to GxP and FDA consists of
DESIGN SPECIFICATION
In the context of software development, "design specification" refers to a document that outlines the technical details and requirements for a software system. The document typically includes information on the system architecture, data structures, algorithms, and other technical aspects of the software design.
Therefore, "design specification in SVV procedure" refers to the process of ensuring that the software design meets its requirements and specifications through various verification and validation activities.
PART11
"Part 11" refers to a section of the Code of Federal Regulations (CFR) Title 21, which outlines the requirements for electronic records and electronic signatures in the pharmaceutical and medical device industries.
In the context of the System Verification and Validation (SVV) procedure, Part 11 compliance means that the software system meets the requirements outlined in the CFR Title 21 Part 11, specifically with respect to electronic records and signatures.
Part 11 compliance requires software systems to have certain features and controls in place, such as user authentication and access control, audit trails, electronic signatures, and data backups, to ensure the integrity, confidentiality, and availability of electronic records and signatures.
Therefore, Part 11 compliance is an important component of the SVV procedure for software systems in the pharmaceutical and medical device industries, as it ensures that the software systems meet the regulatory requirements for electronic records and signatures.
RISK ANALYSIS
Risk analysis is an important component of the System Verification and Validation (SVV) procedure that involves identifying and evaluating potential risks associated with the software system. Risk analysis is necessary to ensure that the software system is safe, reliable, and effective for its intended use.
The risk analysis process typically involves:
1. Identifying potential risks: This involves identifying potential hazards or risks associated with the software system, such as data loss, system failure, or security breaches.
2. Analyzing the likelihood and severity of risks: This involves assessing the likelihood of a risk occurring and the severity of its potential impact.
3. Developing risk mitigation strategies: This involves developing strategies to minimize the likelihood or impact of identified risks.
4. Implementing and monitoring risk mitigation strategies: This involves implementing the identified risk mitigation strategies and monitoring their effectiveness over time.
Overall, risk analysis is an essential component of the SVV procedure as it helps to identify potential risks early in the software development process, allowing developers to design and implement software systems that are safe, reliable, and effective for their intended use.
IQ
Installation Qualification (IQ) is a component of the System Verification and Validation (SVV) procedure that involves testing and verifying that the software has been correctly installed and configured according to the design specification.
The IQ process ensures that the software is installed correctly and that it operates as intended in its designated environment. The IQ process typically includes activities such as verifying that the software has been installed on the correct hardware and software platforms, checking that the software is properly licensed, and verifying that any necessary configuration settings have been properly set up.
Overall, the IQ process ensures that the software system is installed correctly and is ready to move forward with the next phase of SVV testing, which typically includes functional testing and performance testing.
OQ
Operational Qualification (OQ) is a component of the System Verification and Validation (SVV) procedure that involves testing and verifying that the software system operates correctly in its intended operating environment.
The OQ process typically includes activities such as functional testing, performance testing, and stress testing to verify that the software system operates as intended and meets its performance specifications. The OQ process also involves verifying that the software system meets any regulatory requirements or standards that may apply to its intended use.
Overall, the OQ process ensures that the software system is operating correctly and meets its intended performance specifications in its operational environment. Successful completion of the OQ process is typically a requirement before a software system can be considered fully validated and ready for release to production.
PQ
Performance Qualification (PQ) is a component of the System Verification and Validation (SVV) procedure that involves testing and verifying that the software system performs correctly under its expected operating conditions.
The PQ process typically includes activities such as load testing, stress testing, and endurance testing to verify that the software system meets its performance requirements under varying levels of workload and usage scenarios. The PQ process also involves verifying that the software system meets any regulatory requirements or standards that may apply to its intended use.
Overall, the PQ process ensures that the software system performs correctly and meets its intended performance specifications in its operational environment, under expected and unexpected usage scenarios. Successful completion of the PQ process is typically a requirement before a software system can be considered fully validated and ready for release to production.
OQ
The Operational Qualification (OQ) protocol is a document that outlines the procedures and requirements for testing and verifying that a software system operates correctly in its intended operating environment. The OQ protocol is a component of the System Verification and Validation (SVV) procedure.
The OQ protocol typically includes the following sections:
1. Introduction: This section provides an overview of the OQ protocol and its purpose.
2. Scope: This section defines the scope of the OQ protocol, including the software system being tested, the operating environment, and the testing objectives.
3. Responsibilities: This section outlines the responsibilities of the testing team, including the testing plan, execution, and reporting.
4. Test procedures: This section outlines the specific test procedures that will be performed, including functional testing, performance testing, and stress testing.
5. Acceptance criteria: This section defines the acceptance criteria for the software system, including performance specifications, regulatory requirements, and any other relevant standards.
6. Reporting: This section outlines the reporting requirements for the OQ protocol, including the format and content of the test results.
Overall, the OQ protocol is a critical component of the SVV procedure, as it ensures that the software system operates correctly in its intended operating environment and meets its performance specifications. Successful completion of the OQ protocol is typically a requirement before a software system can be considered fully validated and ready
PQ
The Performance Qualification (PQ) record is a document that contains the results and findings of the Performance Qualification testing that was conducted as part of the System Verification and Validation (SVV) procedure.
The PQ record typically includes the following information:
1. Introduction: This section provides an overview of the PQ record and the purpose of the PQ testing.
2. Scope: This section defines the scope of the PQ testing, including the software system being tested, the operating environment, and the testing objectives.
3. Test results: This section presents the results of the PQ testing, including the performance specifications, the test scenarios and conditions, and the test results data.
4. Deviations and exceptions: This section documents any deviations or exceptions that were encountered during the PQ testing and how they were addressed.
5. Conclusion: This section provides a summary of the PQ testing results and whether the software system met its performance requirements.
Overall, the PQ record is an important document that provides a comprehensive record of the PQ testing that was conducted as part of the SVV procedure. The PQ record provides evidence that the software system has been tested and verified to perform correctly under its expected operating conditions and meets its intended performance specifications.
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