6 TECH OUTLOOKMay 2016Copyright © 2016 ValleyMedia Inc. All rights reserved. Reproduction in whole or part of any text, photography or illustrations without written permission from the publisher is prohibited. The publisher assumes no responsibility for unsolicited manuscripts, photographs or illustrations. Views and opinions expressed in this publication are not necessarily those of the magazine and accordingly, no liability is assumed by the publisher thereof.MAY - 2016Mailing AddressValleyMedia Inc.44790 S. Grimmer Blvd Suite 202, Fremont, CA 94538T:510 230 0396, F:510-894-8405 MAY - 2016, Vol 02 - 05 Published by ValleyMedia Inc. To subscribe to Pharma Tech OutlookVisit www.pharmatechoutlook.com Editor-in-ChiefStacey SmithEditorial StaffSalesVisualizerStephen ThomasSukirti AgnihotriAaron Pierce Alex D'SouzaAva GarciaJenna VegasJoshua ParkerSupriya KumaraswamyPharmaceutical Compliance SpecialMaria D'Souza maria@pharmatechoutlook.comEditorialStacey Smith Editor-in-ChiefWith stringent federal mandates on regulatory updates and pricing validation, pharmaceutical compliance today is under increased scrutiny. The challenges in the compliance arena that deter stricter compliance implementation are primarily due to standalone processes and data management inadequacies. Adoption of newer technologies, added security concerns, and expectation of transparent processes also add to the existing complexities. As clinical developments and trials increasingly transcend geographies, adherence to regulatory standards of emerging markets is a necessity, and the compliance partners have to be highly knowledgeable about the various laws and regulations across countries. With a spate of product recalls in the recent past, pharmaceutical companies have to effectively combat the risks in store by taking a relook at their strategies on IT governance, risk, and compliance initiatives and strategies. While failure to adhere with regulatory obligations results in remediation programs and penalties during audits and inspections, tarnished brand reputations also stand as a high risk factor. There are numerous solutions that can help enterprises mitigate these challenges by aggregating enterprise data, and analyzing and identifying the risks to successfully comply with global regulations. In this scenario, the SaaS-based global compliance softwares can integrate with every element of the compliance and risk management programs to effectively assess and manage a wide range of requirements. These solutions also cater to audits, and quality processes of suppliers, standards and policies, documentation, and self-assessments for proactively resolving the issues. The comprehensive offerings can effectively help companies meet FDA regulatory compliance requirements of Good Manufacturing Practice (GMP) and Electronic Signatures and Records (21 CFR Part 11) and Drug Supply Chain Security Act (DSCSA), through one integrated platform while ensuring lower cost of ownership.On that note, we present to you a special edition on Pharmaceutical Compliance. This edition features the Top 10 Pharmaceutical Compliance Solution Providers, listing the proponents--both vendors and consultants--whose key solutions portfolio exude trust and deliver the impetus for improved compliance and ultimately the quality.Securing the Compliance TrailTECH OUTLOOKTECH OUTLOOK
< Page 5 | Page 7 >