BLOG ALL AllCSACSA/CSVValidationFDA/ISOeQMSPolarion CSAA Comprehensive Guide to Software Risk Assessment following CSA Approach READ POST CSA/CSVCSA vs. CSV: How They Differ in Terms of Processes, Standards, and Outcome in the Medical Device Industry READ POST ValidationDigital Twin Manufacturing: Your Sidekick for Maintaining the Validated State READ POST FDA/ISOChallenges and Solutions for Achieving FDA 21 CFR Part 11 Compliance through CSV and CSA READ POST CSA/CSVApplying CSV/CSA Principles to Cybersecurity in Regulated Industries READ POST CSA/CSVDigitalization in Manufacturing – Why it’s time to start your Transformation Yesterday READ POST CSA/CSVThe Future of AI/ML in CSA/CSV Software Verification and Validation READ POST ValidationValidation of packaging and sterilization – What Manufacturers get wrong? READ POST CSA/CSVCSA (vs) CSV: Major steps involved in the Validation Process? READ POST CSA/CSV, FDA/ISOThe Future of CSV and CSA in FDA 21 CFR Part 11 Compliance: Trends, Innovations, and Best Practices READ POST FDA/ISOGuide on How to Pass the FDA’s 5 Stage Goals to Launch Medical Devices to Market READ POST CSA/CSVComputer Software Assurance (CSA) for Lab Systems | Applications and Risk Analysis READ POST CSA/CSVA Comparative Analysis of Scripted Testing (Vs) Unscripted Testing READ POST CSA/CSVEnsuring Data Integrity in Medical Device Industry: Techniques for Data Life Cycle Management READ POST CSA/CSVDigital Agile CSA | How to leverage Agile project methodologies when validating computer systems? READ POST eQMSGuide for achieving rapid success with QMS READ POST FDA/ISOIEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing? READ POST FDA/ISOFDA 21 CFR Part 312-Requirements | Inspection | Audit Checklist READ POST PolarionPolarion ALM Software | How to ease FDA 21 CFR Part 11 Compliance with Polarion Software? READ POST PolarionStreamlining Your Workflow Process | A Guide to Polarion REST API READ POST PolarionSaMD Audit Support | How to Address the Challenges SaMD? READ POST FDA/ISO21 CFR Part 820 vs ISO 13485(2016) Differences and Similarities READ POST CSA/CSV, FDA/ISOFAQs on CSA & CSV: FDA CSA Regulatory Requirements READ POST eQMSImportance of a Training Management System in Life Sciences Industry READ POST eQMSHow eQMS helps to avoid FDA Warning letters? READ POST FDA/ISOISO 9001 Document Control Checklist READ POST eQMSISO 9001 Quality Management System | Requirements | Purpose | Benefits | Life Sciences READ POST eQMSTMS | Training Management System | Essential features of TMS READ POST FDA/ISOFDA 483 observations and Warnings 2021 | What are the most common FDA 483 inspection observations? READ POST CSA/CSVHow is CSA and CSV related? How to maintain Compliance in the Medical Device Industry? READ POST eQMSHow Training Management System helps to ease the training in Life Sciences Industry ? READ POST FDA/ISORMP-Risk Management Plan | ISO 14971 Risk Management Plans for Medical Device Industry READ POST eQMSCAPA Software | What are the major functions of CAPA Management Software ? READ POST FDA/ISO, eQMSDocument Version Control | Importance of Version Control in a Document Management System READ POST FDA/ISOISO 13485:2016 – Important Facts to Know About Quality Management System READ POST Validation, FDA/ISOProcess Validation | US FDA Medical Device Validation Process | Why it’s Important? READ POST eQMSDocument Change Control | Why is DCC a must-have process in life science industries? READ POST eQMSRecords and Documents in QMS | How can records and documents linking increase the level of quality? READ POST CSA/CSVShipping Validation FDA Guidance | Is CSA applicable to Shipping Validation? READ POST FDA/ISOFDA EUA | FDA Emergency use Authorization for Medical Devices READ POST FDA/ISO21 CFR Part 11 Compliance | Must-have features of Quality Management System READ POST FDA/ISOFDA Issues Proposal To Amend The Medical Device Quality System Regulation READ POST FDA/ISOChange Control | How to Manage a Change Management Process? READ POST FDA/ISOMedical Device Recall: How does US FDA recall Medical Device work? READ POST eQMSQuality Assurance -What are the benefits of Software Quality Assurance ? READ POST eQMSRisk Management – How to document a Risk Management Plan (RMP)? READ POST eQMSCAPA Software for Medical Device | When and What Should Trigger a CAPA? READ POST eQMSRisk management – How to Identify, Analyze, and Control Risks? READ POST ValidationData Integrity and Paperless Validation in Life Sciences READ POST ValidationHow Paperless Validation helps meet Compliances in Bio-Sciences ? READ POST eQMSDocument Management Tips for Medical Device Companies READ POST eQMSDocument Control vs. Document Management READ POST eQMSHow to improve efficiency with a Document Management System? READ POST eQMSDocument Control for Medical Device Companies READ POST eQMSStep-by-Step instructions to write a Non-Conformance Report READ POST eQMSCAPA PROCESS – STEP-BY-STEP INSTRUCTIONS READ POST eQMSQuality Assurance vs. Quality Control READ POST eQMSWhy Non-Conformance Management is important? READ POST eQMSYour Quality Management is Failing and Here’s Why READ POST eQMSFrom Root Cause to Real Cause READ POST eQMS7 Key Elements of a Quality Management Software READ POST FDA/ISOFDA 483 Observations vs. Warning Letter READ POST FDA/ISO, eQMSCAPA Process Improvements READ POST FDA/ISO7 Common Medical Device Regulatory Compliance Problems READ POST FDA/ISOWhat is the FDA’s approach to regulating AI/ML in SaMD (software as a medical device)? READ POST ValidationWhat makes for a great Validation Lead? READ POST eQMSStep by Step approach to achieve an FDA/MDIC approved Quality Management System READ POST eQMSWhy is an electronic Quality Management System (eQMS) important? READ POST CSA/CSVCSA – Is Computer Software Assurance Cheating? READ POST FDA/ISOFDA’s New Computer Software Assurance – Impacted SOPs READ POST