Gayathri Thangavelu

ICH :- It stands for International council on Harmonization. The ICH guidelines are as follows.. i.e. Quality Safety Efficacy Multidisciplinary

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Building it Right vs. Building the right things Understanding verification and validation. Throughout my career in development, ensuring quality has always been a top priority. I've come to rely on two critical processes: Verification and Validation. While these terms might seem similar, they play distinct roles in delivering high-quality, reliable products. Based on my experiences, here's how they differ: 🔍 Verification: Are we Building the product right? - Definition: Verification involves evaluating work products at each development phase to ensure they meet specified requirements. - Purpose: Ensure the product or system complies with specified requirements and design specifications. - Activities: Includes reviews, inspections, walkthrough, and testing. Timing: conduct during the development phase. ✅ Validation: Are we building the Right Product? - Definition: Validation focuses on evaluating the final product to ensure it meets the business needs and requirements. - Purpose: Ensures that product meets the needs and requirements of the end-users or stakeholders. Activities: system testing, User acceptance Testing and deploying the product in a live environment to test its performance under actual operation conditions. Timing: conducted after verification, during or after the final stages of development. Summary: Verification ensures the correctness of the development process and intermediate products, while validation ensures the final product meets user needs and performs reliably.

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In the world of pharma, Computer Software Assurance (CSA) is a modern approach to guaranteeing the trustworthiness of software used throughout the product lifecycle. It moves away from the traditional, document-heavy Computer System Validation (CSV) method. Here's the gist of CSA in pharma: Risk-Based: CSA focuses on activities based on the potential consequences of software malfunction. High-risk systems get more scrutiny. Flexible and Agile: CSA allows for a wider range of tools and methodologies compared to the more rigid CSV approach. Focus on Data Integrity: Ensuring the accuracy and reliability of data throughout its lifecycle is a prime concern in CSA. Leverages Automation and Supplier Assurance: Taking advantage of digital tools and trusting qualified software suppliers are encouraged in CSA. The overall goal of CSA is to achieve the same level of confidence in software as CSV, but with a more efficient and adaptable process. This translates to: Faster Time to Market: Streamlined processes can potentially get drugs to patients quicker. Reduced Costs: Less paperwork and a focus on high-risk areas can lead to cost savings. Improved Software Quality: A focus on ongoing assurance activities can lead to more reliable software. If you're interested in learning more, you can search for "FDA Computer Software Assurance for Production and Quality System Software" #CSV #CSA #Validation #21CFR #USFDA

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Let’s Explore Veeva QMS Vault and Its Applicability to the Pharmaceutical Industry!! Veeva QMS Vault is a powerful quality management system designed specifically for the life sciences industry. Here are some of its standout features: Document Control: Veeva QMS Vault provides robust document management capabilities, including version control, document workflows, and electronic signature support. Change Control and CAPA: The system streamlines change control processes, allowing organizations to efficiently manage and track changes to documents, processes, and systems. Training Management: Veeva QMS Vault offers comprehensive training management functionalities, helping organizations effectively handle employee training and qualifications. Quality Event Management: Efficiently manage quality events such as deviations, investigations, and complaints using Veeva QMS Vault. Regulatory Compliance Support: Aligned with FDA regulations, GxP guidelines, and industry standards, Veeva QMS Vault simplifies compliance efforts with preconfigured templates and workflows. Analytics and Reporting: Gain insights into quality performance, compliance metrics, and trends through robust analytics and reporting features. Collaboration and Workflow Automation: Enhance cross-functional collaboration with configurable workflows, automated notifications, task assignments, and approvals. Integration with Veeva Suite: Seamlessly integrate with other Veeva solutions (e.g., Veeva CRM and Veeva Vault RIM) for end-to-end visibility and data consistency.

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In my early days of QA, document reconciliation seemed like an overwhelming task. But over time, I’ve developed a methodical approach that has not only simplified the process but also ensured our projects remain compliant and efficient. Here’s my step-by-step guide, packed with personal insights and real-world examples, to help you master document reconciliation in QA. 1. Gather All Relevant Documents :- Start by collecting all the necessary documents. This includes specifications, test plans, test cases, test results, and any other related files. I once worked on a project where missing just one document delayed our audit by weeks. Having a checklist of required documents helps prevent such issues. 2. Verify Document Completeness :- Ensure each document is complete and up-to-date. This means checking for signatures, dates, and all necessary sections. In one instance, an incomplete test report almost led to a major non-compliance issue during an audit. Double-checking completeness can save you from such headaches. 3. Cross-Check for Consistency :- Compare documents to ensure they align with each other. Specifications should match test plans, and test results should correspond with test cases. I recall a project where discrepancies between test cases and results caused confusion and rework. Consistency checks are crucial for avoiding such problems. 4. Highlight and Resolve Discrepancies :- Identify any discrepancies and address them promptly. This might involve updating documents, seeking clarifications, or performing additional tests. During one project, we found a mismatch in test data that required immediate attention. Resolving discrepancies early can prevent larger issues later on. 5. Maintain a Reconciliation Log :- Keep a detailed log of the reconciliation process. Document any changes made, reasons for discrepancies, and actions taken to resolve them. This log was invaluable during a client audit, providing a clear trail of our QA efforts and demonstrating our commitment to quality. 6. Review and Approve :- Once reconciled, documents should be reviewed and approved by relevant stakeholders. This final check ensures all issues have been addressed and documents are ready for submission or audit. In one case, an additional review caught a minor error that could have had significant implications. Document reconciliation may seem tedious, but its importance cannot be overstated. For instance, in a recent project, thorough reconciliation helped us pass a surprise audit with flying colors. The auditor praised our meticulous documentation, which not only ensured compliance but also boosted our client’s confidence in our processes. By following these steps, you can streamline your document reconciliation process and enhance the quality and compliance of your projects. Remember, attention to detail and a systematic approach are key to successful document reconciliation.

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In regulated environments, electronic signatures are crucial for GxP compliance, documenting actions like reviews or approvals. Unlike identification events, which only log an individual's activity (e.g., system login), electronic signatures can change a record’s status (e.g., draft to final). For instance, approving a report with an e-signature versus logging in to acknowledge an alarm. Companies must define when e-signatures are required, ensuring controls are in place. Each signature must clearly show the signer’s identity, date and time, and meaning.

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