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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 compliance  access control   B) GMP Compliance The following functionality includes production process controls, laboratory controls, and labeling procedures to help manufacturers comply with GMPs. Comment field for specified raw materials Hazardous materials threshold ranges are based on component percentages and tolerance ranges Hazardous materials can be located by expanding formulas Prints customized labels containing product and hazardous data Conflicting hazard statements are identified and prioritized 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 compliance


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 compliance  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 compliance  (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...
Compliant Manufacturing Operations in Life Sciences Companies: Compliant Operations to Lead the Competition
For many life sciences organizations, a key impediment to compliant manufacturing operations remains the disconnect between enterprise and plant systems. This

gmp compliance  sciences company, compliance with GMP and validation of that compliance is critical to the development and delivery of quality products and responsible, sustainable corporate profitability. Whether at the product level or the process level, regulatory noncompliance can affect your company through fines, penalties, negative publicity, loss of customers, or the prohibition against selling your products in the market. Manufacturing controls play an essential role in meeting those compliance requirements. Read More...
It’s About Process (or Ability to be Responsive) -- Part II
Part I of this blog series introduced the notions of workflow automation and business process management (BPM). It also tackled the similarities and subtle

gmp compliance  digitize good manufacturing practice (GMP) tasks, standard operating procedures (SOPs) and work instructions. They can also enable corrective action/exception management, Hazard Analysis and Critical Control Point (HACCP) monitoring procedures, and also orchestrate high-level processes and manage data between various disparate systems and empower domain experts to solve production problems immediately on the shop floor. For more information on BPM, see TEC’s earlier articles entitled Business Process Read More...
Guide to Tax Collection Compliance: Ending the Nightmare
In mid-market report: the changing face of sales and use tax compliance, find out just how bad the problem has become, and what midsized companies ...

gmp compliance  to Tax Collection Compliance: Ending the Nightmare What a mess! the chief financial officer (CFO) exclaimed, lamenting his midsized company's losing effort to comply with sales and use tax requirements. Keeping on top of dozens of shifting tax regulations for scores of products in hundreds of jurisdictions has become an ongoing nightmare. In Mid-market Report: The Changing Face of Sales and Use Tax Compliance , find out just how bad the problem has become, and what midsized companies like yours can Read More...
Don’t Let Wireless Detour Your PCI Compliance
The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and

gmp compliance  Let Wireless Detour Your PCI Compliance The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and present danger to network security and those who collect, store or transmit card holder data must take steps to assure that it is secure, whether or not wireless is deployed in the cardholder data environment. Organizations that handle payment card data must take steps to secure the CDE against wireless Read More...
HIPAA Compliance and the eSureIT Online Backup Service
The US Health Insurance Portability and Accountability Act (HIPAA) of 1996 applies to health care providers, health plans, and clearing houses that

gmp compliance  Compliance and the eSureIT Online Backup Service The US Health Insurance Portability and Accountability Act (HIPAA) of 1996 applies to health care providers, health plans, and clearing houses that electronically maintain or transmit health information. Among other things, these entities are required to have data backup plans, disaster recovery plans, and emergency mode operation plans. Fortunately, there is a way to meet these security and contingency requirements. Read More...
ITAR Compliance with SAP GTS
If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to

gmp compliance  Compliance with SAP GTS If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them. Read More...
Selecting Manufacturing ERP for ISO 26000 Compliance
ISO 26000 spells out best practices for corporate social responsibility (CSR). Are your enterprise systems, including ERP, capable of documenting CSR best

gmp compliance  Manufacturing ERP for ISO 26000 Compliance The UN Global Compact is an initiative supported by heads of state of more than 190 countries to encourage businesses worldwide to adopt sustainable and socially responsible policies, and to report on their implementation. It has been in existence since 2000.  Since 2005, The International Organization for Standards (ISO) has been working on a standard to provide guidelines for social responsibility. ISO 26000, which is targeted for publication in Read More...
Enterprise Search for E-discovery Compliance
Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply

gmp compliance  Search for E-discovery Compliance Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance. Read More...
The High Costs of Non-compliance for Manufacturers
What manufacturers must realize is that through efforts to comply with regulatory standards, they can make their manufacturing operations more competitive

gmp compliance  High Costs of Non-compliance for Manufacturers The High Costs of Non-compliance for Manufacturers If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Cincom Enterprise Compliance and Quality Management helps manufacturers improve revenue, profits, and customer satisfaction by delivering a fully integrated suite of solutions that resolve issues quickly and prevent recurrence, ensuring compliance with industry and regulatory requirements. Read More...
Paths out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole
Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and

gmp compliance  out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and costly for retailers. Eliminating the violations—and, thereby, eliminating the deductions—is in the best interests of both parties. Find out how a system that automates information handling processes, as well as compliance enforcement and monitoring, can help. Read More...

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