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Published By: Collaborative Consulting     Published Date: Dec 20, 2013
An integrated launch plan was just the start for helping to transform a research organization into a commercial entity. A successful commercial launch of an FDA-approved specialty drug included project management support to a cross-functional client team and development of a dashboard tool to track each function’s progress.
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collaborative consulting, biotech organization, case study, launch strategy, biotech company, infrastructure, tailored segment, particular market
    
Collaborative Consulting
Published By: Ecora Software     Published Date: Aug 15, 2007
21 CFR Part 11 continues to cause confusion. Recent FDA guidance documents help, but many IT departments still struggle to establish appropriate validation processes with limited time and resources. Ecora's FREE in-depth guide, "Achieving Sustainable IT Compliance to 21 CFR Part 11," gives you an overview of the regulation from an IT perspective. It also outlines how you can accurately and cost-effectively implement a systems-based best practices approach that will help you meet FDA requirements.
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21 cfr part 11, compliance, electronic records, electronic data, electronic signatures, information management, pharm, pharmaceuticals
    
Ecora Software
Published By: PTC     Published Date: Aug 21, 2009
In February 2004, the FDA issued a Draft Guidance requiring the electronic submission of labeling content to be provided in an XML-based format called Structured Product Labeling (SPL). The purpose of this white paper is for the reader to gain an understanding and prepare for the FDA's new electronic labeling submission standard.
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best practices, enterprise software, product lifecycle management, plm, product information, product information management, pim, catalog
    
PTC
Published By: SyberWorks     Published Date: Oct 21, 2008
Jean Ann Larson, Chief Learning Officer (CLO), and Tawanna Foggs, Educational Systems Coordinator, of William Beaumont Hospitals, talk about their use of the SyberWorks Learning Management System to train and certify hospital employees.
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syberworks, learning management system, learning management systems, learning management system, e-learning, elearning, web based training, training management systems
    
SyberWorks
Published By: UL EduNeering     Published Date: Jul 05, 2012
This paper summarizes the results of a quantitative benchmarking survey to over 200 Life Science organizations. The study identifies the key compliance and performance improvement training topics they had addressed in 2011 along with key issues for 2012.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: SyberWorks     Published Date: Oct 21, 2008
In most cases, the biggest quandary an organization must solve is to put together a rational, i.e., a cost justified, business case why they should spend capital to invest in a learning management system. The focus of this white paper will outline the benefits of web-based training along with a practical framework for developing ROI when looking at the cost of traditional training methods verses e-Learning.
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syberworks, e-learning, roi, global workforce, just-in-time learning, learning management systems, learning management system, e-learning
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
The e-Learning industry has grown tremendously since the early days of computers and the Internet. Today there are lots of products and services out in the market place from which to choose. This white paper will provide some basic information to help you as you begin your research into e-Learning and learning management systems. The document is not meant to be the complete source of information on e-Learning nor will these guidelines be suitable for every single situation. This white paper has been created as a learning aid help you get started. These findings represent the research, experience, and techniques gleaned from working in e-Learning since its infancy in the late 80’s to today. At the end of the paper, Bob Goldschneider, Director of Business Development at SyberWorks, Inc., will provide a summary and closing remarks.
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syberworks, e-learning, internet, aicc, scorm, learning management systems, learning management system, e-learning
    
SyberWorks
Published By: ProofSpace     Published Date: Aug 07, 2007
This white paper presents a solution framework for Life Science Organizations that want to implement enterprise digital trust management to protect their electronic value chain.
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proofspace, proofmark, signing key vulnerability, trustworthy time, authenticated time stamps, time existence of data, electronic postmark, time stamp
    
ProofSpace
Published By: ProofSpace     Published Date: Aug 17, 2007
This white paper defines the life cycle of an electronically signed record and describes  the requirements for handwritten signature-equivalence throughout its retention period.
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proofspace, proofmark, signing key vulnerability, trustworthy time, authenticated time stamps, time existence of data, electronic postmark, asymmetric key cryptography
    
ProofSpace
Published By: SyberWorks     Published Date: Oct 21, 2008
Claudia Innes, Corporate Marketing Director for Fairchild Semiconductor, Inc. discusses their use of the SyberWorks Hosted e-Learning Solution to create a marketing-information portal to provide marketing and performance support for their sales staff, sales engineers, partners, and distributors in the power-supply segment.
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syberworks, e-learning, elearning, performance support, learning management systems, learning management system, e-learning, web based training
    
SyberWorks
Published By: Panasonic Business Mobility Solutions     Published Date: Nov 15, 2016
As the food industry races to comply with the FDA Food Safety Modernization Act (FSMA), manufacturers are working to adopt more robust track and trace processes. A critical component to achieving compliance is the integration of automated data capture solutions throughout all stages of food production—from farm to table. This whitepaper examines technology considerations food manufacturers should weigh when implementing these systems, along with how to tackle the subsequent challenges that are sure to arise. Once the U.S. food industry understands how mobile solutions can enable track & traceability, manufacturers will be equipped with an efficient solution that not only helps to achieve regulatory compliance, but also improves overall business efficiencies.
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Panasonic Business Mobility Solutions
Published By: UL EduNeering     Published Date: Jul 05, 2012
Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The Food and Drug Administration (FDA) has dusted off its regulatory authority to prosecute GMP violations.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: Compliance Associates     Published Date: Jun 29, 2015
Are you feeling the pressure to meet FDA guidelines on Quality by Design (QbD) principals for Process Validation? Existing manufacturing, LIMS, ERP and document management tools are lacking integration and on demand view of your processes. They have hidden costs, risks and create delays to scalable product manufacturing and revenue. Since the FDA is demanding scientific arguments to support process and product development activies and a lifecyle approach, consider the value of a purpose built app for Process Validation. This new class of APP will bring your products to market faster and lower the risk of costly delays. Download the Primer to learn more.
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regulatory compliance services, validation services, regulatory compliance, fda rulings, validator, validation, validation consultants
    
Compliance Associates
Published By: UL EduNeering     Published Date: Jul 05, 2012
Cost reduction is a key criteria that executives often use when choosing initiatives to focus on. They are the ones that have the greatest potential to impact an organization's bottom line. Across life science organizations, a critical area for cost containment is training management.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: Great Bay Software     Published Date: Jan 09, 2019
"Only 51% of device makers follow guidance from the FDA to mitigate or reduce inherent security risks. See how hospitals can harness the benefits of connected medical devices to achieve operational efficiencies, provide better patient care and reduce the overall risk to patient safety. Watch this on-demand webinar to discover: • Emerging issues and trends that are risky to healthcare IT systems and can directly affect patient safety, violate their trust and impact revenue • Best practices for shoring up network security blind spots with real-time asset inventory, network authentication and automated enforcement controls • Why real-time endpoint visibility is the key to achieving an effective and proactive cybersecurity strategy"
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Great Bay Software
Published By: ETQ     Published Date: Jul 10, 2019
The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019. Download this paper to learn more about these two changes from the U.S. Food and Drug Administration’s proposal to harmonize and modernize its Quality System Regulation (QSR).
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ETQ
Published By: UL EduNeering     Published Date: Jul 05, 2012
SOPs are critical to efficient manufacturing operations, quality control, and regulatory compliance. This paper reviews best practices for the Life Science industry for training on SOPs, and how learning management technology has the potential to improve learner retention through automated assessments.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
Third party intermediaries have played starring roles in some of the most highly publicized global corruption trials. By any measure, third party intermediaries routinely rank high on the list of compliance worries for brand companies.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11
    
UL EduNeering
Published By: SyberWorks     Published Date: Oct 21, 2008
This blind case study focuses on the operations division of a Fortune 500 company had significant challenges training its franchisees. They struggled with an 8 to 12 month backlog in providing training for their new franchisees coming on board. Anecdotally, when they did get around to training new people, the requirements and curriculum were outdated and in the process of being revised. Their franchisees and employees were never current on updated company policies and procedures. These franchises were spread all over the country, so it was costly to train their franchisees using traditional onsite training methods.
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syberworks, learning management system, roi, learning management systems, learning management system, e-learning, elearning, web based training
    
SyberWorks
Published By: QuantumMethod     Published Date: Jul 28, 2011
There's growing recognition that marketers can no longer afford to wait for specific guidelines from the FDA. Jump on the social media bandwagon or be left blow'n in the wind. Are you prepared? b
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digital, pharma, social media, advertising, fda, brand, consumer, drug
    
QuantumMethod
Published By: Cymfony     Published Date: Sep 13, 2007
The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it. However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications.
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health, healthcare, pharmaceuticals, pharmaceutical, social media, fda, compliance, cymfony
    
Cymfony
Published By: Cymfony     Published Date: Sep 13, 2007
The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it. However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications.
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health, healthcare, pharmaceuticals, pharmaceutical, social media, fda, compliance, cymfony
    
Cymfony
Published By: Actiance, Inc.     Published Date: Jan 15, 2015
But what seems like a spoon full of sugar is often a tough pill to swallow when you consider regulatory requirements from agencies like the FDA for use of these networks. Adopting new technologies that allow employees to share information and exchange ideas with each other and with your customers is often the best way to achieve better business results, but doing so can involve considerable risk. That’s because the content people create using these technologies is subject to the scrutiny of regulators, legislators, and litigators. On top of that, increasing litigation has made it a business requirement to consider solutions that help bring down skyrocketing legal costs. Pharmaceuticals companies must be knowledgeable of, and abide by, specific information retention regulations in every country where they do business, including those countries that prohibit data from leaving the countries’ borders. Not having technology in place to help manage these requirements and increasing risks, or
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collaboration, social media risk and reward, retention regulations, data, business requirements
    
Actiance, Inc.
Published By: Intralinks     Published Date: May 29, 2013
Ensuring the security of confidential, sensitive information is an essential element of enterprise Security and Governance, Risk Management and Compliance programs. Regulations, such as the HIPAA, FDA, and SOX, place significant requirements on organizations for securely sharing sensitive data such as confidential personally identifiable information (PII) and personal health information (PHI).
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security, sensitive information, sharing, mobile file sharing, solutions, confidential
    
Intralinks
Published By: Blue Lane     Published Date: Apr 03, 2007
Find out how Blue Lane's unique approach can help health care IT pros quickly secure hard to patch servers.
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ips, intrusion, patching, vulnerability, regulations, fda, security, hipaa
    
Blue Lane
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