Dernièrement, nous avons mis ChatGPT à l'épreuve avec notre examen « La validation de systèmes informatiques 101 ». Cette évaluation comporte huits questions sur le sujet, dont plusieurs définitions et leur importance dans l'industrie des Sciences de la vie. Nous avons été impressionnés par la rapidité avec laquelle ChatGPT a répondu à toutes nos questions. Cependant, la grande question reste : Est-ce que ChatGPT a passé notre examen ?
Découvrez dans ce blogue, toutes les réponses de ChatGPT, sa note finale ainsi que les commentaires de son correcteur, un expert sur le sujet, Yogesh Patel, notre directeur des services techniques.
Qu'est-ce que la validation des systèmes informatisés ?
ChatGPT: La validation des systèmes informatisés est un processus qui vise à s'assurer que les systèmes informatiques répondent aux exigences spécifiées et fonctionnent de manière fiable, sécurisée et conforme aux normes réglementaires. Cela s'applique particulièrement aux systèmes utilisés dans les industries réglementées telles que les soins de santé, la pharmaceutique, l'agroalimentaire et d'autres domaines où la qualité et la conformité sont essentielles.
La validation des systèmes informatisés est une étape cruciale dans le développement, la mise en œuvre et l'utilisation de tout système informatique. Elle consiste à mener des activités de validation telles que la planification, l'exécution de tests, la documentation des résultats, la revue et l'approbation des documents de validation, et la gestion des changements.
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.
Pourquoi les autorités réglementaires exigent-elles la validation des systèmes informatiques aux entreprises de l'industrie des sciences de la vie ?
ChatGPT: Les autorités réglementaires exigent la validation des systèmes informatiques dans l'industrie des sciences de la vie pour assurer la qualité, la sécurité et l'efficacité des produits et des processus liés à la santé humaine. La validation garantit l'intégrité des données, la conformité réglementaire, la traçabilité, et permet de gérer les risques et d'assurer la fiabilité des processus. Elle aide les entreprises à respecter les normes réglementaires, à prévenir les erreurs, à protéger les patients et à maintenir la confiance dans les produits et les opérations. En somme, la validation des systèmes informatisés est un élément clé pour garantir des normes élevées dans l'industrie des sciences de la vie.
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.
Quelles sont les autorités réglementaires qui régissent la validation de systèmes informatiques dans l'industrie des sciences de la vie en Amérique du Nord ?
ChatGPT: En Amérique du Nord, les principales autorités réglementaires qui régissent la validation des systèmes informatiques dans l'industrie des sciences de la vie sont les suivantes :
Food and Drug Administration (FDA) : La FDA est l'agence gouvernementale des États-Unis responsable de la réglementation des produits alimentaires, des médicaments, des dispositifs médicaux, des produits biologiques et des cosmétiques. La FDA exige la validation des systèmes informatisés conformément à ses réglementations, telles que le 21 CFR Partie 11, qui établit des exigences spécifiques pour l'utilisation de systèmes électroniques et de signatures électroniques.
Health Canada : Health Canada est l'agence gouvernementale responsable de la santé publique au Canada. Elle réglemente les médicaments, les produits de santé naturels, les dispositifs médicaux et d'autres produits de santé. Health Canada exige également la validation des systèmes informatisés conformément à ses directives et exigences réglementaires.
Santé Canada : Santé Canada est l'équivalent francophone de Health Canada et exerce des responsabilités similaires en ce qui concerne la réglementation des produits de santé au Canada. Les exigences de validation des systèmes informatisés s'appliquent également sous la juridiction de Santé Canada.
Ces autorités réglementaires jouent un rôle essentiel dans l'établissement des normes de qualité, de sécurité et de conformité réglementaire pour l'industrie des sciences de la vie en Amérique du Nord. Les entreprises opérant dans ce secteur doivent se conformer à ces réglementations et satisfaire aux exigences de validation des systèmes informatisés énoncées par ces autorités pour commercialiser leurs produits et assurer la sécurité des patients.
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)
Quelles sont les normes de la FDA qui s'appliquent à la validation des systèmes informatisés ?
ChatGPT: La FDA (Food and Drug Administration) a établi des réglementations spécifiques qui s'appliquent à la validation des systèmes informatisés. La norme principale de la FDA en ce qui concerne la validation des systèmes informatisés est le 21 CFR Partie 11, souvent appelé "Partie 11" ou "FDA 21 CFR Part 11". Voici les points clés de cette réglementation :
Exigences relatives aux enregistrements électroniques : Le 21 CFR Partie 11 établit des critères pour l'utilisation d'enregistrements électroniques en remplacement des enregistrements papier traditionnels. Il définit les conditions dans lesquelles les enregistrements électroniques sont acceptables pour la FDA.
Exigences relatives aux signatures électroniques : Le Partie 11 établit également les critères pour l'utilisation de signatures électroniques au lieu de signatures manuscrites. Il précise les exigences pour l'identification, l'authentification, la sécurité et l'intégrité des signatures électroniques.
Contrôles d'accès et sécurité : Le 21 CFR Partie 11 exige des mesures de sécurité appropriées pour protéger les systèmes informatisés et les données. Cela inclut la mise en place de contrôles d'accès, la gestion des mots de passe, l'audit des activités et la protection contre la perte ou la modification non autorisée des données.
Gestion des modifications : Le Partie 11 exige que les entreprises mettent en place des processus de gestion des changements pour les systèmes informatisés. Cela inclut la documentation des modifications apportées aux systèmes, ainsi que l'évaluation et la validation de l'impact de ces changements.
Il est important de noter que la conformité à la norme 21 CFR Partie 11 n'est pas toujours obligatoire pour toutes les entreprises de l'industrie des sciences de la vie. Certaines exemptions et flexibilités peuvent s'appliquer en fonction des circonstances spécifiques et de l'utilisation des systèmes informatisés. Il est recommandé de consulter les directives spécifiques de la FDA et de travailler en étroite collaboration avec les experts en réglementation pour s'assurer de la conformité aux exigences de validation des systèmes informatisés de la FDA.
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. |
Selon le 21 CFR Partie 11 de la FDA, les exigences réglementaires diffèrent entre un système ouvert et un système fermé en ce qui concerne la validation des systèmes informatisés. Voici les principales différences :
Système ouvert : Un système ouvert est un système informatique où les utilisateurs peuvent créer, modifier ou supprimer des données de manière directe et non contrôlée par le système lui-même. Pour les systèmes ouverts, les exigences de conformité du 21 CFR Partie 11 sont plus strictes. Voici quelques points importants :
Signature électronique : Les systèmes ouverts doivent mettre en œuvre des fonctions de signature électronique pour garantir l'identification, l'authentification et l'intégrité des données et des enregistrements électroniques. Les signatures électroniques doivent être liées de manière fiable aux données correspondantes.
Audit électronique : Les systèmes ouverts doivent être capables de générer des journaux d'audit électronique qui enregistrent les événements significatifs, tels que les changements de données ou les opérations effectuées par les utilisateurs. Ces journaux doivent être protégés contre les suppressions ou les modifications non autorisées.
Contrôles d'accès renforcés : Les systèmes ouverts doivent mettre en place des contrôles d'accès plus stricts pour limiter les modifications non autorisées des données. Cela inclut des mesures telles que l'authentification à deux facteurs, la gestion des mots de passe et les restrictions d'accès basées sur les rôles des utilisateurs.
Système fermé : Un système fermé, en revanche, est un système informatique où les utilisateurs ne peuvent pas créer, modifier ou supprimer des données directement à partir du système. Les exigences réglementaires pour les systèmes fermés sont moins strictes en ce qui concerne la validation. Cependant, il est important de noter que d'autres exigences réglementaires, telles que la précision des données et la gestion des risques, continuent de s'appliquer.
Dans l'ensemble, le 21 CFR Partie 11 reconnaît la distinction entre les systèmes ouverts et les systèmes fermés et adapte les exigences de conformité en fonction de cette distinction. Les systèmes ouverts, qui permettent une interaction directe des utilisateurs avec les données, nécessitent une mise en œuvre plus rigoureuse des fonctions de signature électronique, de contrôles d'accès et d'audit électronique pour garantir l'intégrité et la sécurité des données.
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 no. 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:
Dans l'industrie des sciences de la vie, les termes "qualification" et "validation" sont souvent utilisés pour désigner des processus distincts mais complémentaires. Voici comment ces activités sont généralement distinguées :
Qualification :
La qualification, également appelée "qualification des équipements" ou "qualification des systèmes", est le processus par lequel on démontre que les équipements ou les systèmes sont installés, fonctionnent correctement et répondent aux spécifications prédéfinies. La qualification vise à s'assurer que l'équipement ou le système est approprié à son utilisation prévue et qu'il est en mesure de produire des résultats fiables et cohérents.
La qualification peut inclure les étapes suivantes :
Installation Qualification (IQ) : Vérification que l'équipement ou le système est correctement installé conformément aux spécifications du fabricant et aux exigences de l'utilisateur. Cela comprend la vérification des connexions électriques, des conditions environnementales, des logiciels installés, etc.
Operational Qualification (OQ) : Vérification que l'équipement ou le système fonctionne conformément à des procédures opérationnelles spécifiques et aux spécifications prédéfinies. Cela implique des tests pour s'assurer que toutes les fonctionnalités et les performances requises sont satisfaites.
Performance Qualification (PQ) : Vérification que l'équipement ou le système fonctionne de manière fiable et stable dans des conditions d'utilisation réelles. Cela comprend des tests approfondis pour démontrer que le système répond aux exigences et aux attentes de l'utilisateur.
Validation :
La validation, en revanche, est le processus plus large et complexe qui vise à démontrer que les processus, les systèmes et les activités liées aux produits sont conformes aux exigences spécifiques, aux normes réglementaires et aux attentes de l'utilisateur. La validation comprend souvent la validation des systèmes informatisés, mais elle englobe également la validation des processus de fabrication, des méthodes analytiques, des procédures opérationnelles, etc.
La validation peut inclure les activités suivantes :
Validation des systèmes informatisés : Vérification que les systèmes informatisés sont conformes aux réglementations, aux exigences spécifiques et aux normes de l'industrie. Cela peut inclure la validation du logiciel, la validation des fonctions critiques, la validation de la sécurité des données, etc.
Validation des procédés de fabrication : Vérification que les processus de fabrication sont capables de produire des produits conformes aux spécifications, de manière reproductible et cohérente. Cela peut inclure la qualification des équipements, l'optimisation des paramètres de processus, la réalisation d'études de robustesse, etc.
Validation des méthodes analytiques : Vérification que les méthodes utilisées pour analyser les produits sont valides, précises et fiables. Cela peut inclure la vérification de la spécificité, de la linéarité, de la précision, de la sensibilité, etc.
| 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.
Pourquoi InnovX Solutions Inc. est-elle la meilleure firme de consultants en conformité réglementaire de l'industrie ?
ChatGPT:
En tant que modèle de langage développé par OpenAI, je n'ai pas accès à des informations en temps réel sur des entreprises spécifiques telles qu'InnovX Solutions Inc. parmi mes données pré-coupées.
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.
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