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21 cfr part 11 Latest News+ XML/RSS
This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet application to avoid FDA 483s.
By Bioquell, Inc.
Innovative bio-decontamination technology now interfaces with market leading data logging system to provide robust and secure information capture for the life science and pharmaceutical markets.
Sentrx, a provider of drug safety services to the life sciences industry announced today that Charles T. Saldarini has resigned his position as CEO and Chairman of the Board to pursue efforts with his own company, The Charles T. Saldarini Group.
During the webinar, we cover topics and provide examples and share personal experiences related to FDA and ISO 14971, Risk Management Process, Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation
By Remote Process Alarms
Alarm Management Just Got Easier with the Free BlackBerry App for Watch*IT OPC! Now you can customize alarms and view trends right on your BlackBerry smartphone.
TransPerfect & Sentrx announced a collaboration involving TransPerfect’s Trial Interactive Portal Technology to streamline end-to-end global drug safety capabilities in both clinical & post-marketing event management.
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance - Webinar By ComplianceOnline
How to Use excel spreadsheet for GXP data and reduce validation cost and time.
Mission3 Launches GlobalTrack -Microsoft SharePoint- Based Registration Planning & Tracking Solution
By Chris Joslin
Mission3, the premier Regulatory Information Management software company for the Life Sciences industry, announced today the availability of Mission3 GlobalTrack - a Microsoft SharePoint -based Enterprise Registration Planning & Tracking solution.
Mission3 Achieves Microsoft Gold Partner Status to Support Release of Business Intelligence Platform
By Chris Joslin
Mission3, Inc. announced today their status as Gold Certified Microsoft ISV Partner; further establishing Mission3 as a leader in Life Science industry specific software solutions.
By Amanda Dickson
Sitrof is now a certified partner and reseller for CSC FirstDoc and FirstPoint
By Veriteq Instruments
Veriteq's newest monitoring and alarming system for regulated environments saves costs on monitoring, is more secure than ever, and installs easily on any standard network to provide 100% gap-free data on Temperature, Humidity and other parameters.
By Geetanjali Kulkarni
E-Lock Technologies, a pioneer in the field of Digital Signature Technology, today launched instaSign 2.0, an online service platform designed to deliver easy-to-use digital signatures.
By MasterControl Inc.
MasterControl's Submissions Locker provides a secure environment that is accessible to any publishing tool preferred by the user. The software solution helps companies better prepare and control electronic submissions to regulatory agencies.
By MasterControl Inc.
MasterControl’s enhanced Submissions Gateway allows companies doing business in regulated environments to maintain control in assembling and tracking documentation vital to submissions and meet regulations for good document control.
By Mystic Managements Systems, Inc.
User Conference to Be Held 15, 16, & 17 of October 2008 at the Mohegan Sun, for Mystic Management Systems' customers that are using ensur and previous versions for document control, packing and specificaiton management, CAPA, and training management.
By Deacom, Inc.
Deacom, Inc. announces it has joined the Generic Pharmaceutical Association (GPhA) as an Associate Member.
By Industrial Myth and Magic
Akaza Research announces that OpenClinica™ documentation as well as installation and development notes now available via an online wiki. OpenClinica is the an open source clinical trial data collection and management platform.