{"product_id":"comsoft-21-cfr-part-11-software-0554-1705","title":"ComSoft 21 CFR Part 11 Software","description":"\u003cdiv style=\"text-align: left;\"\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eOverview\u003c\/h2\u003e\n\u003cp style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003eThe Testo ComSoft 21 CFR Part 11 software is an intuitive and fully validatable solution specifically designed for the stringent requirements of the pharmaceutical industry. This powerful software ensures compliance with FDA regulations within a closed system, with its conformity to CFR directives independently confirmed.\u003c\/p\u003e\n\u003cp style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003eIt allows for the comprehensive graphic and tabular display of all measurement parameters, facilitating effortless data analysis and report generation. From managing critical data to ensuring maximum security and traceability, ComSoft 21 CFR Part 11 streamlines your workflow while upholding the highest industry standards.\u003c\/p\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eWhy It Matters\u003c\/h2\u003e\n\u003cp style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003eIn highly regulated environments like pharmaceuticals, data integrity, security, and traceability are paramount. This software is essential for maintaining compliance with FDA 21 CFR Part 11, providing a robust framework for electronic records and signatures. It safeguards your data against tampering, ensures comprehensive audit trails, and simplifies the validation process, making it indispensable for critical data logging applications.\u003c\/p\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eWhat's Included\u003c\/h2\u003e\n\u003cul style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003e\n\u003cli\u003eTesto ComSoft 21 CFR Part 11 Software (download with registration) for PC installation\u003c\/li\u003e\n\u003cli\u003eInstruction manual\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eFeatures \u0026amp; Benefits\u003c\/h2\u003e\n\u003cul style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003e\n\u003cli\u003e\n\u003cstrong\u003eDigital Signature \u0026amp; Audit Trail:\u003c\/strong\u003e Ensures traceability of user activities, offering maximum security and safety.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTamper-Proof Data Storage:\u003c\/strong\u003e Stores raw data in a secure file format, preventing unauthorized alterations.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eError Detection:\u003c\/strong\u003e Utilizes checksums to detect transfer errors, maintaining data integrity.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInactivity Lockout:\u003c\/strong\u003e Prevents unauthorized access by automatically locking the system after periods of inactivity.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntuitive User Interface:\u003c\/strong\u003e Guides users through work steps, enabling effortless data export, report creation, and analysis.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eComprehensive Data Evaluation:\u003c\/strong\u003e Displays and evaluates all recorded measurement parameters in both graphic and tabular formats.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCustomizable Measurement Menus:\u003c\/strong\u003e Tailor menus and organize data loggers into clear tree structures based on application site.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAdvanced Functions:\u003c\/strong\u003e Includes online measurement capabilities, formula creation, and scientific-statistical evaluation (min.\/max.\/mean value, limit value violation).\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eApplications\u003c\/h2\u003e\n\u003cul style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003e\n\u003cli\u003ePharmaceutical manufacturing and storage monitoring\u003c\/li\u003e\n\u003cli\u003eValidation processes for regulated environments\u003c\/li\u003e\n\u003cli\u003eLaboratory data management\u003c\/li\u003e\n\u003cli\u003eQuality control and assurance in sensitive industries\u003c\/li\u003e\n\u003cli\u003eMonitoring critical transportation routes for temperature-sensitive goods\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eTradie Pro Tip\u003c\/h2\u003e\n\u003cblockquote style=\"border-left: 4px solid #007acc; background-color: #f9f9f9; font-style: italic; padding: 15px; margin: 20px 0;\"\u003e\u003cp style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003e\"For pharmaceutical applications, ensure your Testo data loggers are regularly calibrated and integrated seamlessly with ComSoft 21 CFR Part 11. This proactive approach not only maintains compliance but also provides an unchallengeable audit trail for all your critical environmental data, saving you time and stress during inspections.\"\u003c\/p\u003e\u003c\/blockquote\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eTechnical Specifications\u003c\/h2\u003e\n\u003ctable style=\"width: 100%; border-collapse: collapse; border: 1px solid #e0e0e0; font-size: 16px; margin-bottom: 20px;\"\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth style=\"color: #007acc; border: 1px solid #e0e0e0; padding: 10px; text-align: left; background-color: #f5f5f5;\"\u003eSpecification\u003c\/th\u003e\n\u003cth style=\"color: #007acc; border: 1px solid #e0e0e0; padding: 10px; text-align: left; background-color: #f5f5f5;\"\u003eValue\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd style=\"border: 1px solid #e0e0e0; padding: 10px;\"\u003eSystem requirements\u003c\/td\u003e\n\u003ctd style=\"border: 1px solid #e0e0e0; padding: 10px;\"\u003eWindows® 10; Windows® 11; others on request\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"border: 1px solid #e0e0e0; padding: 10px;\"\u003eStandards\u003c\/td\u003e\n\u003ctd style=\"border: 1px solid #e0e0e0; padding: 10px;\"\u003eCFR 21 Part 11 (in use with testo ComSoft CFR-Software)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003ePair With\u003c\/h2\u003e\n\u003cul style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003e\n\u003cli\u003eTesto 175H1 Temperature and Humidity Data Logger\u003c\/li\u003e\n\u003cli\u003eTesto 175T1 Temperature Data Logger\u003c\/li\u003e\n\u003cli\u003eTesto 176H1 Four-channel Humidity and Temperature Data Logger\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 style=\"color: #007acc; border-bottom: 2px solid #f0f0f0; padding-bottom: 8px; margin-top: 35px;\"\u003eEnhance Your Data Compliance\u003c\/h2\u003e\n\u003cp style=\"font-size: 16px; line-height: 1.6; margin-bottom: 20px;\"\u003eElevate your data compliance and security. Purchase the Testo ComSoft 21 CFR Part 11 software today and ensure your pharmaceutical operations meet the highest standards of data integrity.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c!-- Automated FAQ Schema --\u003e\n\u003cscript type=\"application\/ld+json\"\u003e\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is Testo ComSoft 21 CFR Part 11 software designed for?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The Testo ComSoft 21 CFR Part 11 software is an intuitive and validatable solution specifically tailored for the pharmaceutical industry. It helps fulfill the FDA's requirements for closed systems regarding electronic records and signatures.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What key security features does this software offer?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The software provides maximum security through features like digital signatures, a comprehensive audit trail for user activity traceability, storage of raw data in a tamper-proof file format, detection of transfer errors using checksums, and an inactivity lockout to prevent unauthorized access.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What are the system requirements for ComSoft 21 CFR Part 11?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The software requires Windows\u0026#174; 10 or Windows\u0026#174; 11. Other operating systems may be supported upon request.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How does the software support data evaluation?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"It allows for the display and evaluation of all recorded measurement parameters in both graphic and tabular formats. Additionally, it offers online measurement, formula creation, and scientific-statistical evaluations (min.\/max.\/mean value, limit value violation).\"\n      }\n    }\n  ]\n}\n\u003c\/script\u003e","brand":"Testo","offers":[{"title":"Default Title","offer_id":43530481369147,"sku":"0554 1705","price":4249.88,"currency_code":"AUD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0316\/7787\/4235\/files\/comsoft-cfr-image.jpg?v=1779246712","url":"https:\/\/www.hvacshop.com.au\/products\/comsoft-21-cfr-part-11-software-0554-1705","provider":"HVAC Supply Shop","version":"1.0","type":"link"}