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Automotive Industry and Food, Safety, and Drug Regulations
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to

gmp regulatory  specifies legal requirements for GMP in the EU, and it requires that data be available at the proper time, provided in a readable form, and protected against damage or loss. ICH Q7A Guideline— International Conference on Harmonization (ICH) Q7A provides guidelines for active pharmaceutical ingredients in the EU, the US, and Japan. PIC/S—The Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the Pharmaceutical Inspection Convention provide guidance on pharmaceutical inspections. Well-attuned Read More...
Regulatory and Compliance
Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirement...
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Documents related to » gmp regulatory


Cloud Computing Forecast—50% Chance of 483s! 3 Things You Should Do To Weather the Storm
And unfortunately, many casual users do not understand the full impact of their actions in the new computing frontier called the cloud. For those in life

gmp regulatory  good manufacturing practices as GMP. Collectively, these are referred to as GxP. Read More...
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

gmp regulatory  | Compliance Needs | GMP Compliance | Reaching Compliance | Developing a Compliance Strategy Process | Developing a Successful Compliance Strategy | Developing a New Compliance Strategy | Developing Compliance Strategy Processes | Success of a New Compliance Strategy | Success of an Effective Compliance Strategy | Success of a Compliance Strategy Solution | Developing Compliance Strategy Solutions | Effective New Compliance Strategy | Effective Compliance Strategy Process | New Compliance Strategy 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

gmp regulatory  Science Resources SOP | GMP Life Sciences | GMP Life Science Companies | GMP Life Sciences Industry | GMP Life Sciences Trade Network | GMP Life Sciences Community | GMP Life Sciences Definition | GMP Life Sciences Research | GMP Life Sciences Library | GMP Life Sciences Database | GMP Life Science Skills | GMP Life Sciences Software | GMP Life Sciences Data Archive | GMP Life Science Products | GMP Life Science Project | GMP Life Science Definition | GMP Life Science Worksheets | GMP Life Science Read More...
Orchid Orthopedic Solutions Selects CEBOS QMS
Orchid Orthopedic Solutions recently selected CEBOS MQ1 Elements Life Sciences solution to automate its quality management system (QMS) and ensure compliance

gmp regulatory  (FDA), good manufacturing practices (GMP), and more. Functionality includes configurable forms and workflows, electronic signatures, audit trails, and validation scripts. The software thus significantly reduces the time required to complete and maintain regulatory compliance while providing staff with visibility to business processes, tasks, and timing.   CEBOS, a division of QAD Inc. , provides a suite of EQMS and environmental, health, and safety management (EH&S) software solutions designed to Read More...
Electronic Content and Record Management Best Practices
Years ago, businesses primarily focused on how to compile valuable information that could be shared within the organization. But today’s regulatory requirements

gmp regulatory  Content and Record Management Best Practices Years ago, businesses primarily focused on how to compile valuable information that could be shared within the organization. But today’s regulatory requirements have changed all that. By adhering to several fundamental guidelines, organizations can improve data accessibility, and at the same time create a proactive e-discovery environment. Find out why establishing content management principles is critical to your success. Read More...
From Text to Business Insight: All about Enterprise Text Analytics
Text analytics automates the extraction of business value from Web sites and social media content, from e-mail and survey responses, to regulatory filings and

gmp regulatory  Text to Business Insight: All about Enterprise Text Analytics Text analytics automates the extraction of business value from Web sites and social media content, from e-mail and survey responses, to regulatory filings and corporate documents. These sources and others capture information from and about customers, prospects, products, companies, and competitors in human readable form. Download this white paper for a handy guide to understanding—and profiting from—enterprise text analytics. Read More...
Better Active Directory Auditing, Less Overhead, More Power
Today's organizations, faced with stricter internal security policies and multiple regulatory compliance requirements, continue to struggle in their efforts to

gmp regulatory  Active Directory Auditing, Less Overhead, More Power Today's organizations, faced with stricter internal security policies and multiple regulatory compliance requirements, continue to struggle in their efforts to make Active Directory auditing simpler and more adept at fulfilling their needs. Native Windows auditing mechanisms don't meet the demands of modern businesses, and administrators are often left in the dark about significant and potentially harmful Active Directory changes. Learn how to Read More...
Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance
One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley

gmp regulatory  Information Overload: A Logical Approach to Managing Endpoint Security and Compliance One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to Read More...
Global Trade Regulatory Software: Vendor Obstacles and User Recommendations
The acquisition of Vastera by JPMorgan Chase indicates that finance in GTM is just as important as the physical movement of goods. However, there are still a

gmp regulatory  Trade Regulatory Software: Vendor Obstacles and User Recommendations The Merger Rationale At first glance, the acquisition of Vastera (NASDAQ: VAST) by JPMorgan Chase , N . A . (NYSE: JPM) might appear odd. The former is a public, global trade solutions provider and the latter is one of the leading global providers of financial services. However, JPMorgan's encroachment into the global trade management (GTM) software market illustrates that finance is as valuable as the actual movement of goods in Read More...
Dealing with Food Industry Pressures
Small and medium food and beverage companies have the same regulatory requirements as large companies, but with significantly fewer resources with which to

gmp regulatory  with Food Industry Pressures Dealing with Industry Pressures Food and beverage is by far the largest industry in the world, but that doesn't mean that it is a straightforward piece of cake for most food and beverage manufacturers and distributors to capture a bigger slice of the pie. With the growing power of mega-retailers, along with fragmented markets; intricate supply chains; increasing government regulations; variable raw materials; seasonality; package proliferation; and limited shelf Read More...
Health Means More
Medical and health care regulatory norms are tightening worldwide, and all key stakeholders, including payers, providers, and patients are becoming more

gmp regulatory  Means More Medical and health care regulatory norms are tightening worldwide, and all key stakeholders, including payers, providers, and patients are becoming more discerning with regard to the quality of products and services delivered. As a result, the health care and life sciences (HLS) sector is increasingly leaning on analytics to find solutions for improving the delivery of health care—and improving the business of health care. Read More...
Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
The US Food and Drug Administration (FDA) requires pharmaceuticals and medical device companies to comply with numerous standards. Medical device manufacturers

gmp regulatory  the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation, and document approvals must include a signature and date. Removal (or prevention of use) of obsolete documents must also be verified. Written procedures (manufacturing, design, quality control, laboratory, etc.) need to be signed and dated as approved. When reviewing Device Master Record (DMR) and DHR documents, manufacturers must assure that those in use have been signed and Read More...
Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new

gmp regulatory  Compliance with 21 CFR Part 11 Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs. Read More...
10 Critical Factors to control and configuration management (CCM) Success
Is your IT environment suffering? Increasing complexity and the challenges of achieving regulatory compliance within a tight budget could be making it more

gmp regulatory  Critical Factors to control and configuration management (CCM) Success Is your IT environment suffering? Increasing complexity and the challenges of achieving regulatory compliance within a tight budget could be making it more difficult for you to manage change. A traditional change and configuration management (CCM) tool might not be providing all the help you need. Find out how a CCM tool that addresses configuration audit and control can ease your IT infrastructure’s aches and pains. Read More...

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