Software Listing: 21 Cfr Complaint

Ecora Auditor Lite for Windows is a free on-demand, detailed configuration reports for the entire IT infrastructure Ecora Auditor is an agentless Windows software that will install on a Windows workstation and collect hundreds of thousands of configuration settings to generate on-demand, detailed configuration reports. Systems change constantly, and each change whether planned or unplanned can trigger downtime or a security breach. Current IT documentation, especially in today's compliance-driven IT environments, is essential. Documentor eliminates the time-consuming and error prone manual process of data collection and ensures accurate, timely documentation of the IT infrastructure.

  • Publisher: ecora.com
  • Date: 18-6-2009
  • Size: 53760 KB
  • Platform: Win2000, WinOther, WinServer
  • CyNote
  • License: Freeware
  • Price: 0.00
  • Rating

Laboratory notebook using version control system and independent date-time stamping (as notarization), in order to ensure record accountability, auditing, and conforming to US FDA 21 CFR 21's rule on electronic records..

  • Platform: Linux, Mac OS X, WinOther

Chemoventory is a web based software for chemical inventory. It comes in two version: Lite and Standard version. Lite version is free but has limited functionalities. Lite version is ideal for lab/institute/company with single lab or all chemicals in one building and less than 10 chemists and or chemical users and for all those who want enjoy the free version. If more than 10 chemical users and/ or more than one location of chemicals and/ or if you want to manage chemicals, users and want to add extra functionality, we recommend Standard version. All PHP codes are pre-compiled using zend accelarator.

  • Platform: PHP, Scripts

The Password Recovery Console is a web-based application that enables the delegation of password recovery privileges. The Password Recovery Console interface can be accessed from any networked system, and can be configured to allow specific users in your enterprise to recover the password of any or all accounts that have been set and stored by User Manager Pro and/or Random Password Manager. The Password Recovery Console offers granular control that enables Administrators to assign responsibility for recovery of particular accounts or groups of accounts to appropriate employees (such as support or help desk personnel).

  • Platform: Win2000, WinOther

E-Lock ProSigner Lite is electronic signing (digital signature) and verification software. It is Easy to install & user-friendly product. Software is integrated with MS Word, MS Excel & Adobe Acrobat, which enables even the novice users to sign the documents using the toolbar, provided within these applications. ProSigner Lite is also integrated with the Windows, which enables the users to sign or verify files of any format just at right click. ProSigner has the E-Mark component, which enables to create handwritten signature & credentials. Other major features of ProSigner Lite are as follows: - Sign/Verify files of any format, - Digitally sign documents in Rich Text Format (.

  • Publisher: elock.com
  • Date: 17-9-2009
  • Size: 16281 KB
  • Platform: Win2000, Windows Server, Windows Vista, WinOther

SMAC is a powerful, yet an easy-to-use and intuitive Windows MAC Address spoofer SMAC is a powerful, yet an easy-to-use and intuitive Windows MAC Address Modifying Utility (MAC Address spoofing) which allows users to change MAC address for almost any Network Interface Cards (NIC) on the Windows 2000, XP, and 2003 Server systems, regardless of whether the manufactures allow this option or not.SMAC does not change the hardware burned-in MAC addresses. It is not necessary. SMAC changes the "software based" MAC addresses on the Windows 2000, XP, and 2003 Server systems, and the new MAC addresses you change will sustain from reboots.

  • Platform: Win2000, WinOther, WinServer

Monitoringz is a multiuser server-client software application designed for input, storage and processing of sampling results of microbial cleanliness and number of airborne particles in clean production areas, usually called 'environmental monitoring'. It is designed to meet demands of pharmaceutical (GMP) and food (HACCP) industry. By timely sampling and reporting, you can determine and prevent contamination in early stages, before end-product quality is questioned. Application consists of two parts: database back-end in PostgreSQL server and client front-end interface in Microsoft Access. Monitoringz provides:
- Easy and logical input of organization structure and sampling matrix.

  • Platform: Win2000, Windows Server, Windows Vista, WinOther

TestTrack RM is a requirements management solution that manages the complete requirement lifecycle, including planning, workflow, traceability, review, change management, and reporting. Requirements mistakes and scope creep can have the most costly effect on software quality and budget. Whether as a standalone tool or part of Seapine's integrated ALM solution, TestTrack RM helps teams keep development projects on track by facilitating collaboration, automating traceability, and satisfying compliance needs. FEATURES: Requirements Management Software TestTrack RM handles all aspects of requirements management, including planning, workflow, traceability, review, change management, and reporting.

  • Platform: WinOther

From the creation of test cases through the resolution of defects, TestTrack Studio tracks and manages all the details of your testing effort. TestTrack Studio seamlessly blends the award-winning defect tracking features of TestTrack Pro and the time saving test case management features of TestTrack TCM into an integrated test environment. FEATURES: Issue Management: · Track defects, feature requests, change requests, tasks and more. Easy to install, configure, and use, TestTrack Studio is an essential tool for issue tracking and workflow automation. Test Case Management: · TestTrack Studio helps you manage all aspects of the software testing process, including test case creation, scheduling, execution, measurement, and reporting.

  • Platform: WinOther

Tracking defects, issues, and feature requests is a critical component of any software development and quality control process. The earlier and quicker bugs are resolved, the lower your development cost and the higher your product quality. TestTrack Pro puts improved quality, communication, and reporting within reach. Use TestTrack Pro and create better software in less time. FEATURES: Track All Development Artifacts: · Track defects, feature requests, change requests, tasks, and more. Easy to install, configure, and use, TestTrack Pro is an essential tool for issue tracking and workflow automation.

  • Platform: WinOther

Testing software applications requires hundreds to thousands of unique test cases, the time to execute them, and the ability to efficiently manage the results. At the same time, software applications are becoming increasingly more complex and development schedules more aggressive, but quality cannot be compromised. Use TestTrack TCM, Seapine?s complete test case management solution, to manage the testing workload. FEATURES: Test Case Management: · TestTrack TCM helps you manage all aspects of the software testing process, including test case creation, scheduling, execution, measurement, and reporting.

  • Platform: WinOther

The Lab Inventory System is an innovative, easy to learn solution for research laboratories.
You can quickly and easily upload your existing Excel based inventory and get started in minutes, manage laboratory inventory, place orders and keep track of them in one place.
Lab Inventory can provide you with the advanced functionality you require enabling you to regain control of your stuff. Running a laboratory is challenging, and knowing what you have in stock and who has it is extremely important to reduce costs and increase productivity, make things run efficiently.

If you are experiencing problems using the Lab Inventory System then please report your problem to support@atgclabs.

  • Platform: WinOther

Validation Manager is a tool to handle all the cumbersome paperwork of regulated environment validations. Including Validation Plans, protocols, executions and exceptions. Keeping everything in one place and best of all paperless.
21 CFR part 11 Ready, Validation Workflow, Automated Validation Trace Matrix, Web Based, FMEA Tool integrated
Validation Manager License - Apache License V2.0.

  • Platform: WinOther

E-Lock DeskSeal PLUS is a PKCS#7 compliant desktop Digital Signing and Encryption software. It is wizard-based utility which enables even the novice users to sign and encrypt the files of any format with ease without any prior training required. It supports native PDF signing which allows users to insert visible digital signature in the PDF files, which can be verified using adobe reader which promises good interoperatabily.Allows to customize the placement of the signature in the PDF files. Features of E-Lock DeskSeal Products: - Digitally sign PDF files without having Adobe Acrobat Professional installed on the machine - Insert visible signatures and associate image with the signature in PDF files - Option to customize the placement of the signature block in PDF files - PKCS#7 compliant digital signing and encryption - Signing the...

  • Platform: Win2000, Windows Server, WinOther, WinVista

In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The Investigational New Drug (IND) and New Drug Application (NDA) applications are the vehicles through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US. 21 CFR Part 312 and 314 contain regulations applied to conducting clinical trials, working with FDA, applying for drug approval and other related topics.

The IND/NDA booklet App presents the regulations for IND and NDA in a user-friendly e-format.

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, FDA promulgated the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) in 1978. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures, test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification.

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x

The Proceed app is an Android client for the Proceed Product Lifecycle Management solution from Milton Software Corporation. Proceed is a cloud-based enterprise solution that manages product data and the processes that are used to change that data over time, providing traceability throughout.

Proceed manages design data, Bill of Material data, engineering change processes, product configurations, program execution and much more. In particular, Proceed provides capabilities that are specifically aimed at the medical device industry, helping to ensure compliance with FDA 21 CFR Part 11 and Part 820 and with ISO 13485.

  • Platform: Android 3.x, Android 4.4, Android 4.x

A valuable reference tool for medical device Regulatory Affairs (RA) and Quality Assurance (QA) professionals. Quick access to global medical device regulations, daily medical device regulatory updates, quick access to regulatory resources (videos, downloadable regulations, and more) for 24 countries. Also the full text of the US FDA QSR (Quality System Regulation, 21 CFR Part 820) and 10 other US regulations, plus full text of the European Medical Devices Directive (MDD 93/42/EEC) and the IVD Directive (98/79/EC). This app includes regulatory information covering 90% of the global medical device market including:

• Australia
• Brazil
• Canada
• China
• Europe
• India
• Japan
• Mexico
• Russia
• South Korea
• United States

.

  • Platform: Android 2.x, Android 3.x, Android 4.4, Android 4.x
  • Hyper 21
  • License: Shareware
  • Price: 19.95
  • Rating

Do you like the strategy of Black Jack? Do you like the fast paced action of Tetris that keeps you on your toes? Hyper 21 offers the best of both worlds! The dealer constantly deals out cards filling up the playing area. You have to make 21s fast enough to prevent the cards from reaching the bottom. Each level has a number of 21s required to complete the level. When you complete the level you recieve bonus points for every unfilled card slot. The faster you are, the more points you get! As levels progress the dealer gets faster and faster and more 21s are required to complete the levels. Is the dealer too slow for your liking? Tap the right click button and he'll speed up to hyper speed! With multiple difficulties there is a speed for everyone.

  • Platform: Win2000, WinOther

Sams Teach Yourself ASP.NET in 21 Days is the perfect book to introduce beginner and intermediate readers to the new technologies and frameworks presented by ASP.NET. By guiding readers through short but increasingly complex lessons, this book will give readers a strong foundation in ASP.NET, and the knowledge to develop their own creative solutions. Readers will delve into the new framework, the C# and Visual Basic programming languages, and techniques to approach difficult problems. The book will introduce the ASP.NET Framework, Visual Basic .NET, and C#, the new COM framework. The book will cover applications of these technologies.

  • Platform: Asp, Scripts

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