We recently submitted ChatGPT to our Computer System Validation 101 exam, focusing on definitions and their importance in the life science industry. We were impressed by the speed it responded to all our questions. But the burning question remains: Did ChatGPT successfully pass our test?
Below, you'll find all the answers provided by ChatGPT during this exam, including its grade for each question and corrective feedback provided by one of our CSV subject matter experts, Yogesh Patel, our Director of Technical Services.
What is Computerized System Validation?
ChatGPT: Computerized System Validation (CSV) is the process of ensuring that computer systems used in regulated industries (such as pharmaceuticals, medical devices, and food manufacturing) are operating in a consistent and reliable manner and comply with regulatory requirements.
CSV involves verifying and documenting that a computerized system performs its intended functions correctly and consistently, produces accurate and reliable results, and meets regulatory requirements. It is important because computerized systems can affect the safety, efficacy, and quality of regulated products and services.
InnovX Rating: 4/5
InnovX Comments: Computerized System Validation is a regulatory requirement for many countries working in the GxP/Life Sciences industry. It is conducted to verify that the system in question is being used for the right intended purpose and that controls for system operation are in place. Requirements are not only limited to those that come from regulatory bodies. In order to get a perfect score to this question, ChatGPT should have considered that CSV activities will provide insight into how the system will be managed once the system is released to be used in a production environment. Risk management principles are applied to ensure that risks associated to patient safety, product quality, and data integrity are identified, minimized, mitigated, and brought to a controlled and acceptable state.
What is Computer Software Assurance?
ChatGPT: Computer software assurance refers to the set of activities that are performed to ensure that software functions as intended and meets the specified requirements. It involves ensuring that the software is reliable, secure, and operates correctly under different conditions.
The process of software assurance begins with the identification of the software's requirements and continues throughout the software development lifecycle. It involves various activities, including design reviews, code analysis, testing, and validation, to ensure that the software is free from defects and vulnerabilities.
Software assurance is critical for ensuring that the software performs its intended function, meets the user's needs, and complies with industry standards and regulations. It is particularly important for safety-critical systems, such as those used in aerospace, defense, medical, and automotive industries.
Overall, software assurance is an essential aspect of software development, ensuring that the software meets the required quality standards and operates as expected, providing reliable and secure functionality to end-users.
InnovX Rating: 2.5/5
InnovX Comments: The response lacks detail and differentiation from Computerized System Validation. Essentially, CSA is a newer, leaner approach to traditional CSV methodologies, that has been released as a guidance paper by the US FDA in mid-2022 for the Medical Device industry. The pilot project and draft guidance from the FDA was delayed by the COVID-19 pandemic. The newer approach is tailored for companies that haven’t really adopted a risk-based approach to validation and are encouraged to apply a ‘critical thinking’ approach to verification and documentation and focus on critical and high-risk areas of system verification activities. It also allows a regulated company to leverage compatible and acceptable activities conducted by vendors/suppliers to reduce duplication of documentation and testing activities that do not produce additional value. Companies that have poor understanding of CSV and related quality processes may run into compliance risks by adopting a CSA approach.
Why do regulatory authorities require system validation for life sciences?
ChatGPT: Regulatory authorities require system validation in life sciences to ensure that products and processes meet the required quality, safety, and efficacy standards. Life science products, such as drugs, medical devices, and biologics, can have a significant impact on human health, and as such, regulatory bodies must ensure that they are safe and effective before they are marketed and used.
System validation is a process of verifying that a system or process meets its intended use and performs as expected. It involves testing and documentation to ensure that the system is reliable, accurate, and consistent, and that it meets the requirements of the regulatory authorities.
System validation is essential in life sciences because errors or defects in the design, development, or manufacturing process of a product can have serious consequences, including harm to patients or users, recalls, and regulatory sanctions. System validation helps to identify and prevent these errors or defects before the product is released to the market, thereby protecting public health and ensuring compliance with regulatory requirements.
In summary, regulatory authorities require system validation in life sciences to ensure that products and processes meet the required quality, safety, and efficacy standards, and to protect public health.
InnovX Rating: 4/5
InnovX Comments: The response is adequate. The truth is that regulations are usually the result of great tragedy, either loss of human life or financial or legal troubles. The impacted countries or international community come together to address these issues and rectify them with legislation and best practices. These focus groups are usually chaired by experts in their field and propose the best course of action to ensure that future product quality is upheld to the highest standards and that any negative impact to human beings is minimal.
Which regulatory authorities regulate computer system validation in the life science industry in North America?
ChatGPT: Computer system validation (CSV) in the life science industry in North America is primarily regulated by the following authorities:
Food and Drug Administration (FDA): The FDA has specific regulations and guidance documents that pertain to computer system validation in the life science industry. The FDA's regulations, such as 21 CFR Part 11 (Electronic Records; Electronic Signatures), outline the requirements for ensuring the integrity, security, and reliability of electronic records and signatures in regulated environments.
Health Canada: Health Canada provides guidance and requirements related to computer system validation for the life science industry in Canada. Their regulations, such as the Good Manufacturing Practices (GMP) guidelines, require that computerized systems used in the manufacturing, testing, and storage of health products meet certain validation standards.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): The ICH is an international organization that develops guidelines and standards for the global pharmaceutical industry. The ICH guideline Q9 (Quality Risk Management) provides principles and guidance on risk management, including computer system validation, throughout the product lifecycle.
European Medicines Agency (EMA): Although the EMA is not a regulatory authority in North America, it is worth mentioning because it influences regulatory practices globally. The EMA provides guidance documents and regulations, such as Annex 11 (Computerised Systems) of the European Union's GMP guidelines, which outline requirements for computer system validation in the European life science industry.
In addition to these regulatory authorities, industry standards and organizations, such as the International Society for Pharmaceutical Engineering (ISPE) and the Institute of Electrical and Electronics Engineers (IEEE), also provide guidelines and best practices for computer system validation in the life science industry.
It's important for life science companies to be familiar with and comply with the specific requirements and guidance provided by these regulatory authorities when validating computer systems used in their operations.
InnovX Rating: 4/5
InnovX Comments: The US FDA 21 CFR Part 11 and EudraLex Annex 11 are the two (2) most common regulations referenced during a validation project in North America.
Part 11 compliance is only required in the following scenarios:
The system is categorized as GxP.
Records that are required to be maintained in accordance with US predicate rules (a separate and different underlying /regulation or law) that forces require that Part 11 isto be in scope.
If the system is used in the US, manages US data, or the drug/product is available to the US market.
If the system generates, modifies, and/or deletes electronic records.
If the system manages electronic signatures executed to electronic records, handwritten signatures executed to electronic records, and digital signatures executed to electronic records.
Electronic records submitted directly to US agencies (i.e., the FDA).
If electronic records and signatures are used in lieu of/considered to be equivalent to traditional paper records and handwritten signatures executed on paper.
All other cases, Part 11 is included as a regulatory requirement because it provides excellent controls for electronic records and electronic signatures but is not required from a regulatory compliance perspective.
Also, Canada is a member of the Organisation for Economic Co-operation and Development (OECD), and follows many standards established by this international body, such as GLP.
In addition, North America consists of 23 sovereign states and numerous territories. The 3rd most important market would be Mexico, which in 2020, had the second largest pharmaceutical market in Latin America. [1]
Mexican regulations can be found here:
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) / Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
What are the FDA guidelines that apply to computerized system validation?
ChatGPT: The FDA has established guidelines for computerized system validation (CSV) that companies in regulated industries must follow to ensure that their computerized systems meet regulatory requirements and are safe and effective. Here are some of the key guidelines:
Part 11 Electronic Records; Electronic Signatures: This guideline outlines the requirements for electronic records and signatures, including requirements for ensuring the authenticity, integrity, and confidentiality of electronic records.
General Principles of Software Validation: This guideline outlines the general principles of software validation, including the importance of testing and documentation. It emphasizes the need to use a risk-based approach to determine the level of validation required for each computerized system.
Computer Software Assurance for Manufacturing, Operations, and Quality System Software: This guideline provides guidance on how to ensure the quality of computer software used in manufacturing, operations, and quality systems. It emphasizes the importance of testing, documentation, and change control.
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application: This guideline provides additional clarification on the scope and application of the Part 11 guideline, including when electronic signatures are required.
Data Integrity and Compliance With CGMP: This guideline emphasizes the importance of data integrity and provides guidance on how to ensure the accuracy, completeness, and consistency of data used in regulated industries.
These guidelines help ensure that companies in regulated industries follow best practices for CSV and comply with regulatory requirements. Companies must follow these guidelines to ensure that their computerized systems are reliable, accurate, and compliant with regulatory requirements, which is critical to the safety and efficacy of the products and services produced by those industries.
InnovX Rating: 4.5/5
InnovX Comments: The response captures the de facto guidelines! It would have been nice for the dates of each publication to be included as well because each guideline represents a specific thinking/timepoint in the evolutionary timeline, and it’s important to know the correct order in which each document was released. For example, the US FDA General Principles of Software Validation was released in January 2002, so you need to be mindful of a guideline published 20 years ago!
How do regulatory requirements differ between an open system and a closed system according to 21 CFR Part 11?
ChatGPT: According to 21 CFR Part 11, the regulatory requirements for open systems and closed systems in the context of electronic records and signatures differ in several aspects. Here are the key differences:
​ | Open System | Closed System |
|---|---|---|
Definition | An open system refers to a computerized system where the hardware and software components are not tightly controlled or limited to specific vendors. Open systems allow for greater flexibility and customization. | A closed system, on the other hand, is a computerized system in which the hardware and software components are tightly controlled and limited to specific vendors. Closed systems are typically less flexible and customizable. |
Validation | For open systems, the validation process focuses on ensuring that the system is fit for its intended purpose and meets the requirements defined by the user. The validation process involves thorough testing, documentation, and verification of the system's functionality and performance. | Closed systems typically require less extensive validation efforts compared to open systems. Since closed systems are tightly controlled by specific vendors, the validation responsibility often lies with the vendor, who is expected to provide evidence that the system meets the regulatory requirements. |
Documentation | Open systems require comprehensive documentation to demonstrate compliance with 21 CFR Part 11. This includes documenting the system's configuration, security measures, audit trails, validation protocols, and any changes made to the system over time. | While closed systems also require documentation, the level of detail and extent may vary compared to open systems. Vendors of closed systems are generally expected to provide documentation that demonstrates compliance with the relevant regulatory requirements. |
System Access and Security | Open systems often require more robust security measures to ensure the integrity, confidentiality, and availability of electronic records and signatures. This includes implementing user access controls, encryption, audit trails, and regular system monitoring and maintenance. | Closed systems typically have built-in security features provided by the vendor. The responsibility for ensuring the security of the system often lies with the vendor, who must implement appropriate access controls, authentication mechanisms, and other security measures. |
It's important to note that the specific requirements for open and closed systems may vary depending on the specific implementation and interpretation of 21 CFR Part 11 by regulatory authorities and organizations. It's recommended to consult the relevant regulatory guidance and seek professional advice to ensure compliance with the specific requirements applicable to your system.
InnovX Rating: 1/5
InnovX Comments: From the definition perspective, it’s outright incorrect. There are two (2) types of definitions. From the US FDA 21 CFR Part 11 definition, we see the narrow definitions as following:
Open: 21CFR11§11.3 (b) (9): Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.
Closed: 21CFR11§11.3 (b) (4): Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
The second definition is more of a scope understanding based on why there is an Open/Closed System definition in the first place. The key word here is "controlled". When we review 21CFR11§11.30, Controls for open systems, we see that back in 1997, when Part 11 was released, the US FDA foresaw that future technologies would evolve the computerized system from being solely a physical system deployed inside a physical location to one that isn’t restrained by these constructs. With the popularization of the Internet, the open system must now follow the data from start to finish and tracknow becomes a medium by which data through all mediums it passes through, including the Internet. It is difficult will travel through, and that it will become difficult toto control the endpoints of the Internet, hence, the line…shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.
We even see early comments to Part 11, in the Federal Register, Volume 62, Number 54 (13430-13466) under Comment #43: The agency cautions, however, that, where an organization’s electronic records are stored on systems operated by third parties, such as commercial online services, access would be under control of the third parties and the agency would regard such a system as being open.
From the validation definition, validation is the responsibility of the customer. The vendor/supplier may assist with validation activities and provide meaningful deliverables, but the compliance requirements rests with the customer. Whether a system is identified as open or closed, it is the customer the must provide the rationale and basis for testing approach.
From the documentation definition, both open and closed systems must undergo a validation, and most vendors/supplier are in the same regulatory space as the customer, so don’t expect vendors/supplier to have all the regulatory answers you may have.
From the System Access and Security definition: Again, begin with defining the system, understand the security architecture, and base validation testing activities on your customer requirements and specification. If your system is defined as closed, you’ll need to adhere to Part 11 and if your system is open, there some additional requirements that you many need to verify against from a system perspective or with procedure controls.
Are Computer Software Assurance and GAMP5 approaches incompatible in the life science industry?
ChatGPT: Computer Software Assurance (CSA) and GAMP5 (Good Automated Manufacturing Practice version 5) are both approaches used in the life science industry to ensure the quality and compliance of computer software systems. While they have some overlapping principles, they are not inherently incompatible with each other.
CSA is an approach developed by the U.S. Food and Drug Administration (FDA) to enhance the quality, reliability, and security of medical device software. It provides guidance on software development and maintenance practices, risk management, and validation activities specific to medical device software.
GAMP5, on the other hand, is a framework developed by the International Society for Pharmaceutical Engineering (ISPE) that provides guidelines for the validation of computerized systems in the pharmaceutical and life science industries. GAMP5 focuses on ensuring the compliance of automated systems used in manufacturing, testing, and distribution of pharmaceutical products.
While CSA and GAMP5 have different origins and scopes, they can be complementary in practice. The principles and best practices outlined in GAMP5, such as risk-based validation, change control, and documentation requirements, can align with the goals of CSA to ensure the quality and compliance of medical device software.
In summary, CSA and GAMP5 are not incompatible approaches. Instead, they can be integrated and applied in a coordinated manner to achieve the objectives of software quality and regulatory compliance in the life science industry.
InnovX Rating: 4.5/5
InnovX Comments: Right on! I started my career following the guidelines outlined in GAMP®4 and transitioned to what is current in GAMP®5 Revision 2. While I love the guide, and highly recommend this guide to everyone involved in GxP, CSV, and quality related activities in general, it is important to state that I consider the guide to outline the minimum actions and activities that a company should follow. I have worked for many clients that don’t follow GAMP at all, and others that have evolved many tiers beyond what GAMP identifies. What companies need to understand that they need to develop a process that works for them.
CSA should follow the same approach. Companies should really invest time and energy to focus on their existing CSV processes and evaluate what works and what doesn’t. There are many benefits to following new CSA approaches, but some or all may not be the right fit for you.
One thing is for certain – companies that follow or implement new processes where they don’t fully understand the process or let external consultants run the show without any interaction with the business – will always run into issues when going live with their systems or begin to operationally use their procedures.
What distinguishes qualification and validation activities in the life science industry?
ChatGPT:
In the life science industry, qualification and validation activities are distinct but interconnected processes that ensure the reliability, accuracy, and compliance of equipment, systems, and processes. Here are the key differences between qualification and validation:
​ | Qualification | Validation |
|---|---|---|
Purpose | Qualification focuses on establishing documented evidence that equipment, systems, or processes are properly installed, calibrated, and maintained to meet predefined specifications. It verifies that the equipment or system is suitable for its intended use and performs as expected within predefined operating ranges. | Validation aims to demonstrate that a specific process, system, or method consistently produces results that meet predetermined acceptance criteria. It ensures that the process or system consistently delivers the desired outcomes and is compliant with regulatory requirements. |
Scope | Qualification primarily focuses on the equipment or system itself. It involves testing and documenting the physical and functional characteristics of the equipment or system to ensure it meets predefined standards and specifications. | Validation aims to demonstrate that a specific process, system, or method consistently produces results that meet predetermined acceptance criteria. It ensures that the process or system consistently delivers the desired outcomes and is compliant with regulatory requirements. |
Documentation | Qualification activities typically result in a qualification protocol or report, which documents the installation, operational, and performance qualifications of the equipment or system. It includes details such as equipment specifications, calibration records, and verification test results. | Validation activities result in a validation plan and a validation protocol. These documents outline the approach, acceptance criteria, and testing methodologies used to demonstrate the consistent performance and compliance of the process or system. Validation also involves maintaining comprehensive documentation throughout the lifecycle of the validated process or system. |
Lifecycle Stage | Qualification activities primarily occur during the installation and initial commissioning of equipment or systems. It ensures that the equipment or system is properly installed and functions according to predefined specifications. | Validation activities typically occur after qualification and continue throughout the lifecycle of the process or system. It involves periodic revalidation and ongoing monitoring to ensure sustained compliance and performance. |
While qualification and validation activities have their differences, they often go hand in hand, with qualification being an essential prerequisite for validation. Both processes are critical in ensuring that equipment, systems, and processes within the life science industry operate reliably, consistently, and in accordance with regulatory requirements.
InnovX Rating: 4.5/5
InnovX Comments: In my humble opinion, these definitions are neither 100% correct nor are they 100% incorrect. Let me provide my interpretation as someone who has been in the Life Sciences industry since 2005:
Qualification has some historical context with laboratory systems, which is why many people who don’t have laboratory experience often interchange Qualification and Validation. People who have been in the Life Science industry for 15+ years understand that Agilent, HP, Waters, and Thermo Fisher were juggernauts in the field and set the pace for other systems. Terms like IQ/OQ/PQ were commonly used and understood by all.
Qualification requires performing verification activities against requirements from the vendor/supplier.
Qualification: Used for Infrastructure and Equipment (Process, Automation, Manufacturing, Laboratory)
Validation: Information Management Systems, and Equipment (Process, Automation, Manufacturing, Laboratory) where a Computer System is part of the system.
Qualification is a part of Validation.
Alignment of terms: EudraLex Annex 11… computerized systems used as part of a GMP regulated activities. The application should be validated; IT infrastructure should be qualified. Therefore: IT Infrastructure does not perform GxP regulated activities, but it does support systems that do perform GxP regulated activities, hence, Qualification. Therefore: This is why systems are validated because they are the hardware/software that customers purchase to assist with performing GxP regulated activities, hence, Validation.
Validation requires that requirements from the vendor/supplier are met, in addition to requirements from the company using the system and the manner in which the company will use the system (remember ‘intended use’?)
Validation = Qualification (Company Specification) + Company Requirements (Unique to Customer) + Process (Unique to Customer) + Procedures (Unique to Customer).
Qualification: Activities performed by a software vendor/supplier when performing verification testing for their own internal products.
Validation: Activities performed by a customer who uses a vendor/supplier product to assist with compliance or perform GxP regulated activities.
Why InnovX Solutions Inc. are the best regulatory compliance consultants in the industry?
ChatGPT: As an AI language model, I don't have real-time information or access to specific company data beyond my September 2021 knowledge cutoff. Therefore, I cannot provide the most up-to-date information about InnovX Solutions Inc. or any other company. It's important to conduct your own research and consider the latest information when evaluating a company's expertise and reputation.
InnovX Rating: N/A
InnovX Comments: However, InnovX Solutions is more than simply a trustworthy, hardworking, and professional team of IT and computer system validation consultants. We are a highly experienced group of experts who can significantly enhance the value of your projects. We believe that we can outperform our competitors and go beyond their capabilities. Our commitment is to deliver best-in-class services because we firmly believe that you deserve better. We are fully bilingual and agnostic, have collaborated with numerous vendors and have implemented various solutions for life science clients. Our genuine interest lies in the well-being of our clients who choose to partner with us.
Did ChatGPT successfully pass our computer system validation exam?
Based on the assessment conducted by our team, ChatGPT has achieved a score of
71.25%
This grade corresponds to a C or C+, which is disappointing. Therefore, ChatGPT still has room for improvement before meeting the requirements to join our team.
Computerized system validation is a requirement in the life science industry. While it may initially appear daunting, finding the right partner will help you successfully achieve your compliance goals and enhance your overall business performance.
Reach out to InnovX Solutions today to discover our holistic approach to software validation and experience the unparalleled capabilities of our experts.
Yogesh Patel
Director of Technical Services at InnovX Solutions
Yogesh Patel is a seasoned IT/Validation expert who has been working in the GxP sector since 2005. He has experience working with all regulatory frameworks. Currently, he holds the position of Director of Technical Services at InnovX Solutions. You can reach out to him directly at yogesh.patel@innovx.org.