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Software Functionality Revealed in Detail
We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.
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 pharmaceutical industry fda compliance strategy

Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

Compare Now

Regulatory and Compliance RFI/RFP Template

Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology  

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Documents related to » pharmaceutical industry fda compliance strategy

Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry


To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

pharmaceutical industry fda compliance strategy  Compliance Issues in the Pharmaceutical Industry Technology Evaluation Centers, Inc. (TEC) is the first web-native technology research enterprise. TEC provides decision support systems (DSS) that enable stakeholders to objectively identify the software products that best fit their company''s unique business and systems requirements, and that contribute most effectively to superior business performance. Source: Technology Evaluation Centers As a security-specialized system, DEACOM ERP Software for Read More

The Name and Ownership Change Roulette Wheel for Marcam Stops at SSA Global Part Two: Marketing By Invensys


IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market for providing plant-centric ERP solutions might finally play well to capturing the marketing opportunity.

pharmaceutical industry fda compliance strategy  a part of Invensys Pharmaceutical Solutions , another group within the Production Management Division (PMD) of Invensys, and one of the leading suppliers of validation, pharmaceutical, engineering, and regulatory-compliant solutions. Founded in 1994 and with over 110 dedicated consultants, the group has been one of the largest suppliers of regulatory-compliant solutions in North America and Europe, dedicated to the pharmaceutical, biological, biotechnology, and medical devices industry. As the Baan Read More

ERP Issues for the Midsized Life Sciences Company


What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

pharmaceutical industry fda compliance strategy  production processes of the pharmaceutical industry through audits and authorized signoffs. Part 11 is not mandatory. It is called into play if a company chooses to use electronic records. A company may decide to stay with paper-based records and in that case, Part 11 does not apply. GMPs change formally and informally. The U.S. medical device GMPs were formally changed when Congress rewrote them, making them more compatible with the ISO-9001 quality document. The medical devices GMPs were then renamed Read More

Resurrection, Vitality And Perseverance Of Former ERP 'Goners' Part One: Ross Systems & SSA Global Technologies


While an increasing demand for services and incremental purchases of new extended-ERP functionality from existing client base, with a modest ooze of new accounts and even a notable influx of new accounts for distinguished some, may not put the revitalized former ERP losers back on top of the enterprise applications charts, they will likely remain around and not necessarily just to impede mid-market forays of both Tier 1 brethren and the likes of Microsoft.

pharmaceutical industry fda compliance strategy  of iRenaissance Validator for pharmaceutical and biotechnology companies in manufacturing or clinical trials. The product should reduce the efforts, costs, and risks created by increasingly stringent FDA (Food & Drug Administration) regulations, as it provides the master action plan, templates and test scripts needed to quickly complete the IQ, OQ, and PQ (installation qualification, operation qualification and performance qualification) processes, and clearly defines and thoroughly documents each step Read More

How a Leading Vendor Embraces Governance, Risk Management, and Compliance


SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in assisting companies to meet the increasing challenges of corporate compliance and risk management.

pharmaceutical industry fda compliance strategy  Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP''s GRC product suite will be discussed in more detail, and speculation will be made on the product suite''s potential for success within the vendor''s current and prospective customer base. Read More

Striking a Balance between Governance, Risk, and Compliance


Increasingly complex regulatory requirements in the health care industry have intensified pressures on health systems to assure compliance and operational governance while maximizing business performance. This study draws on a survey conducted by Healthcare IT News and Healthcare Finance News to share strategies that will improve governance, compliance, and business performance across today’s health care organization.

pharmaceutical industry fda compliance strategy  a Balance between Governance, Risk, and Compliance Increasingly complex regulatory requirements in the health care industry have intensified pressures on health systems to assure compliance and operational governance while maximizing business performance. This study draws on a survey conducted by Healthcare IT News and Healthcare Finance News to share strategies that will improve governance, compliance, and business performance across today’s health care organization. Read More

Media Industry Solution for Intellectual Property Management


The media industry is undergoing radical change, driven in large part by new technologies such as the Internet, online publishing, and digital broadcasting. And at the heart of the industry is intellectual property. As the number of media and delivery channels explodes, you need to know how to manage rights inventory, license revenue streams, and royalty payments—efficiently and profitably.

pharmaceutical industry fda compliance strategy  Industry Solution for Intellectual Property Management The media industry is undergoing radical change, driven in large part by new technologies such as the Internet, online publishing, and digital broadcasting. And at the heart of the industry is intellectual property. As the number of media and delivery channels explodes, you need to know how to manage rights inventory, license revenue streams, and royalty payments—efficiently and profitably. Read More

Making Strategy Real


How can management communicate the organization’s strategy effectively and assure that the entire organization has bought into it and is aligned with it? Business performance optimization systems are an important tool for success. By using business performance optimization systems, employees are empowered to confidently make timely, strategically-aligned decisions based upon facts, not intuition or corporate politics. See how.

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Infor ION-izes its Open SOA Strategy - Part 2


Part 1 of this blog series started by analyzing a certain change of the guard and a related product strategy shift at Infor. Two late June 2010 news announcements, which were entitled “Infor Simplifies Connectivity and Data Sharing with Infor ION(tm)” and “Infor Selects Microsoft as Preferred Technology and Tools Provider for Infor Software," were then demystified in an

pharmaceutical industry fda compliance strategy   Read More

IBM OpenPages Policy and Compliance Management


This video introduces the IBM OpenPages GRC Platform and, specifically, the Policy and Compliance Management module.

pharmaceutical industry fda compliance strategy  risk management, enterprise risk management, risk management, governance, risk, and compliance, GRC requirements, GRC, corporate GRC, enterprise GRC, IBM OpenPages GRC Platform, enterprise GRC software, risk management solutions Read More

Industry Support in WCM


If you're looking for web content management systems (WCM), I have some stats that might help you key into the features you'd expect to come standard. Here is how vendors offering web content management systems support the functionality in our model of WCM systems. These stats are based on the averages of 11441 product functionality ratings of the vendors published within our WCM knowledge

pharmaceutical industry fda compliance strategy  Support in WCM If you''re looking for web content management systems (WCM), I have some stats that might help you key into the features you''d expect to come standard. Here is how vendors offering web content management systems support the functionality in our model of WCM systems. These stats are based on the averages of 11441 product functionality ratings of the vendors published within our WCM knowledge base. We model WCM systems on a hierarchy of functionality within the following categories. Read More

Enhancing Governance, Risk, and Compliance through Effective Risk Management


Embedding governance, risk, and compliance (GRC) management into all business process has become imperative. Companies need to adopt a holistic view when it comes to reducing and managing risks, and ensure better access risk management. This paper discusses the need for companies to take a proactive approach towards access risk management.

pharmaceutical industry fda compliance strategy  governance,risk management,and compliance,and compliance management,grc management,acess risk management,acess risk management software,grc initiatives,grc risk management,sap grc risk management,it grc management,sap grc enterprise role management Read More

Compliance Tips for Outbound Debt Collection Communications


The largest challenge to successful debt collection efforts today is outbound communications compliance. There are many rules to follow, and requirements are continually evolving.

This white paper looks at some key considerations for collection compliance for outbound communications. These include understanding the compliance landscape in the United States, complying with legal requirements and restrictions to avoid fines, and learning the best practices for obtaining debtor consent for collection communications.

pharmaceutical industry fda compliance strategy  debt collection, outbound debt collection, IVR, interactive voice response, FDCPA, TCPA, CFPB, debt collection compliance Read More

Manage the Global Workforce with a True Cloud Strategy


Oracle VP of HCM Product Strategy Humair Ghauri details the importance of evaluating cloud vendors for security, integration, and extensibility.

pharmaceutical industry fda compliance strategy  global workforce management,cloud HCM strategy,Oracle HCM,Humair Ghauri,HCM extensibility Read More

Compliance: Is Remote Office Data Your Achilles Heel?


Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at securing their data centers, they often forget to secure remote office data. With the consequences of non-compliance ranging from financial penalties to job loss and worse, it could mean the end of your business. Don’t let compliance become your Achilles heel.

pharmaceutical industry fda compliance strategy   Read More