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🔍 Qualification Scripts in Computer System Validation 🔍 In the realm of computer system validation, Qualification Scripts (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ) play a pivotal role. Installation Qualification (IQ) scripts ensure the correct installation of the system, checking for the presence of essential components. Why are Qualification Scripts important? Operational Qualification (OQ) scripts dive deeper, verifying the operational facets against Functional Specifications. Finally, Performance Qualification (PQ) scripts assess whether the system consistently meets user requirements outlined in the Business Requirements document. These scripts are meticulously crafted, referencing technical and functional specifications, and undergo thorough reviews for correctness, completeness, and coverage. In the dynamic landscape of technology, ensuring the seamless integration and performance of computer systems is paramount. #ComputerSystemValidation #QualificationScripts #QualityAssurance #startup #software

VALIDATION PLAN in CSV: A Validation Plan in Computer System Validation (CSV) serves as a comprehensive document outlining the strategy and approach for validating a system. Here's a suggested structure for a Validation Plan: ### 1. Introduction: - **Purpose:** Clearly state the purpose of the Validation Plan, explaining why validation is necessary for the specific computer system. - **Scope:** Define the boundaries of the validation effort, specifying which components of the system are included and excluded. - **References:** Provide references to relevant documents, standards, and regulations guiding the validation process. ### 2. System Overview: - **Description:** Offer a brief overview of the computer system, including its functions, intended use, and criticality in the overall business or regulatory context. - **System Boundaries:** Clearly define the boundaries of the system under validation, specifying interfaces with other systems or processes. ### 3. Project Organization: - **Validation Team:** Identify and introduce key members of the validation team, along with their roles and responsibilities. - **Stakeholders:** List and describe relevant stakeholders, including end-users, IT personnel, and regulatory bodies. ### 4. Validation Approach: - **Validation Lifecycle:** Define the stages of validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). - **Risk-Based Approach:** Describe how a risk-based approach will be used to prioritize validation efforts. - **Validation Testing:** Outline the types of testing to be conducted, such as functional testing, security testing, and performance testing. ### 5. Documentation and Deliverables: - **Document Control:** Detail the document control procedures, including versioning, approval processes, and access controls. - **Deliverables:** Specify the required validation documentation, such as user requirements, specifications, and testing protocols. ### 6. Change Control: - **Change Management Process:** Describe the procedures for handling changes to the validated system, emphasizing impact assessments and documentation updates. ### 7. Training: - **Training Programs:** Detail the training programs for personnel involved in the validation process, emphasizing the importance of their roles. ### 8. Validation Testing Schedule: - **Timeline:** Provide a timeline for each stage of validation testing, highlighting milestones and deadlines. - **Dependencies:** Identify any dependencies that might impact the validation schedule. ### 9. Reporting and Communication: - **Progress Reports:** Specify how and when progress reports will be communicated to stakeholders. ### 10. Conclusion: - **Summary:** Summarize the key points of the Validation.

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What are you Know about Operational Qualification (OQ) in CSV ? OQ (Operational Qualification) is a key phase in Computerized System Validation (CSV). It involves verifying that a system or piece of equipment performs its intended functions under specified operating conditions. In the context of CSV, OQ ensures that the computerized system operates according to its design specifications and performs as expected within defined ranges. Key aspects of OQ in CSV include: 1. **Test Scripts**: During OQ, pre-approved test scripts are executed to verify the system's functionality. These scripts simulate actual use cases and operational scenarios. 2. **System Configuration**: The system's configuration settings are tested to ensure they meet user and operational requirements. 3. **Security and Access Controls**: OQ ensures that user access levels, passwords, and security features function correctly according to the validation plan. 4. **Alarms and Notifications**: Alarm functions and notifications are tested to confirm that they trigger as expected when thresholds are exceeded. 5. **Documentation**: All results of the OQ testing must be documented, including any deviations and corrective actions. Operational Qualification typically follows the Installation Qualification (IQ) phase and is followed by the Performance Qualification (PQ) in CSV. #CSV #Validation #Qualification #EIPICO

Do you know, post pandemic health authorities have changed their approach for inspection, now they are planning to implement AI for continuous inspection and planning to conduct more remote inspections to increase the visibility. What does it mean for us? It means more inspections and increased findings, which in turn will increase the demand for skilled professionals in Life Sciences industry. Many consulting and IT organisations are already offering CSV services but now there is also an increased demand for Lab instrument and equipment qualification, to meet the expectations of client, professionals should have the knowledge of both CSV and qualification. We at Gravy Tech Consulting offers Computer System Validation Training Program, a customised program to cover all the aspects of CSV, CSA, equipment, utilities and analytical instrument qualification. A CSV program that is actually CQV (Commissioning, Qualification and Validation) is designed to meet the current and future demand of Life Sciences industries. If you are interested, come and join our CSV training program, which will started from 12th March. Please see the video for more details.

Hello Professionals, Calling all Recruiters! Ready to elevate your projects to new heights? Let's connect these industry experts with your #Corp to #Corp ("#C2C") needs. Our elite team of engineering talent is geared up and raring to go, bringing unparalleled expertise to your doorstep. Whether you need CSV/CQV Engineers, Equipment Validation Experts, Automation Engineer’s, Quality Engineers, Manufacturing Engineers, Packaging Engineers, Validation Experts, Product Development Engineer, R&D Engineers, we've got you all covered: Share your requirements with us at jaipal@m-compliance.com. Connect with me, for daily updates on consultant availability. Don't miss out on this opportunity to collaborate with the best talent in the field. Let's make waves together. Show your support by giving this post a thumbs up and dropping a "Hotlist of requirements" in the comments" below. #medicaldevice #pharma #CSV #CQV #automation #validation #quality #manufacturing #consultants #collaboration #c2crequirements #hotlist #requirements #dailyrequirements #talentacquisition #directclient

A Validation Engineer plays a crucial role in ensuring that products and systems meet all necessary standards and specifications before they are released to the market. Their tasks in testing and analysis are multifaceted and essential for maintaining quality and compliance. What are the testing Tasks: Test Planning: Validation Engineers develop comprehensive test plans that outline the scope, approach, resources, and schedule of intended testing activities. This includes defining test objectives, criteria for success, and the types of tests to be conducted. Test Execution: They perform various tests, such as functional, performance, stress, and regression tests, to evaluate the product’s behavior under different conditions. This involves using both manual and automated testing tools. Test Documentation: Detailed documentation of test procedures, results, and any anomalies encountered is crucial. This documentation helps in tracking the testing process and provides a reference for future testing cycles. Defect Tracking: Validation Engineers identify, log, and track defects or issues found during testing. They work closely with development teams to ensure that these defects are resolved in a timely manner. Analysis Tasks: Data Analysis: They analyze test data to identify trends, patterns, and potential areas of improvement. This involves statistical analysis and the use of data visualization tools to interpret complex data sets. Root Cause Analysis: When defects are found, Validation Engineers conduct root cause analysis to determine the underlying issues. This helps in preventing similar problems in future releases. Compliance Verification: Ensuring that the product meets all regulatory and industry standards is a key responsibility. Validation Engineers verify that all compliance requirements are met through rigorous testing and analysis. Reporting: They compile detailed reports summarizing the testing and analysis results. These reports are used to communicate findings to stakeholders and to support decision-making processes. #Testing#Validation#Taskes#Rolls#

Today we will talk about Function Specification (FS): In computer system validation (CSV), **Function Specification** is a crucial part of defining and documenting the intended functions of a system or application, ensuring that it meets its operational and regulatory requirements. This specification typically includes detailed information on the functionality the system is expected to provide, forming the basis for validation and testing activities. Here are key components of Function Specification in CSV: 1. **System Overview**: A general description of the system and its purpose within the organization. 2. **Functional Requirements**: A detailed list of all the system's expected functions, such as data input/output, processing rules, workflows, reporting, and security features. 3. **User Interface Specifications**: Descriptions of how the users will interact with the system, including screens, menus, navigation, and data entry forms. 4. **Performance Requirements**: Definitions of how the system should perform under various conditions, including response times, transaction processing speeds, and load handling. 5. **Security and Access Control**: Specifications around user roles, access levels, data encryption, and authentication requirements. 6. **Integration Requirements**: How the system will interact with other systems or software, including data transfer protocols and compatibility. 7. **Error Handling**: Detailed procedures for dealing with errors, including system alerts, error messages, and logging. 8. **Compliance Requirements**: Specific regulations and standards the system must adhere to, such as FDA 21 CFR Part 11, GxP, or other applicable regulatory frameworks. 9. **Testing and Validation Criteria**: The criteria that will be used to validate that the system functions as specified, forming the basis for creating test scripts and scenarios. The **Function Specification** helps ensure that the system delivers the necessary functionality and is compliant with relevant regulatory standards. #CSV #Qualifications #Validation #EIPICO

Validation is NOT just writing and executing protocols “Validation engineer/ validation specialist” may sound like someone who only writes and executes a range of protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Analytical Method Validation (AMV), Cleaning Validation (CV), Process Validation (PV), and Computer System Validation (CSV) protocols, etc.  Validation protocols are just the means to an end: accomplishing regulatory compliance, technical excellence, and business competitiveness. It is utmost important to develop a risk- and science-based validation strategy and tailor the Validation Master Plan (VMP) as per the company’s specific needs. A “one-size-fits-all” approach may work in the short term, but it can lead to major compliance issues and technical failures. Besides performing effective, efficient and compliant validation initially, it is equally important to monitor and maintain the state of validation during routine commercial operations. Over a period of time, unintended and unexpected changes are likely to creep into the systems and the operations may not remain in the state of validation. A validation-gap analysis by comparing the “as-it-is” versus “as-required” status should be performed to develop and implement the remedial action plan in order to bring the operations back into the state of validation. In fact, validation efforts need to be continued throughout the product lifecycle; starting with developing the scientifically sound foundation for validation, performing validation before commencing commercial operations, and maintaining the state of validation during routine commercial operations. Therefore, a validation engineer/ validation specialist should not be perceived as someone who only writes and executes validation protocols.

Common shortcomings I've Spotted in Validation Programs: 🔹 Inadequate User Requirement Specifications (URS): Ensure comprehensive input from all stakeholders to avoid gaps. Regularly update the URS to reflect system changes. 🔹 Data Integrity Issues: Conduct periodic audits and establish robust backup strategies to maintain data integrity. 🔹 Lack of Standard Operating Procedures (SOPs): Develop detailed SOPs for every aspect of the validation process. Consistent staff training ensures SOP adherence. 🔹 Technical Glitches and Software Bugs: Maintain close collaboration with vendors or in-house developers for prompt issue resolution. Assign a dedicated IT liaison for effective communication. 🔹 Integration Challenges: Plan for seamless integration with other systems and instruments to ensure consistent data flow. Spot these errors, fix them, and sail smoothly through your validation journey! Let's discuss more. #Validation #QualityAssurance #Compliance