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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 regulations  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 regulations


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 regulations  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
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 regulations  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
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 regulations  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
Vendors Jostle and Profess Economic Stimulus Readiness - Part II
Part I of this blog series tried to analyze not only the opportunity but also the many related strings attached stemming from the American Recovery and

gmp regulations  price,  guaranteed maximum price (GMP) , time and material (T&M), etc. ensure that the clauses required by ARRA are incorporated into the contract evidence that the lowest responsible bidder was selected evidence that proper approvals occurred given the contract values evidence that expenditures are in compliance with ARRA (preferably prior to the payment) evidence that there is segregation between ARRA and non-ARRA funds evidence that the project is progressing within planned milestones and budget 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.

gmp regulations   Read More
Atrion User Conference Highlights Need for Regulatory Compliance in PLM
The Atrion International User Group met in Montreal, Quebec (Canada) to discuss ways to improve regulatory compliance for their respective companies. At the

gmp regulations  User Conference Highlights Need for Regulatory Compliance in PLM Event Summary The Atrion International User Group met in Montreal, Quebec (Canada) in the fall of 2004 to discuss ways to improve regulatory compliance for their respective companies. Atrion International is a leading provider of material compliance software and data to global manufacturers. It focuses on helping companies maximize regulatory compliance while minimizing costs. The conference was an excellent event for professionals Read More
Managed File Transfer: The Need for a Strategic Approach
A secure and accurate flow of information in your supply chain operations has never been more critical—and complex. Digital transfer of unstructured information

gmp regulations  File Transfer: The Need for a Strategic Approach Managed File Transfer: The Need for a Strategic Approach If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Inovis provides a Managed File Transfer (MFT) platform that is backed by our Tier IV Data Center which offers the highest accredited service level in the industry. Source: Inovis Resources Related to Managed File Transfer (MFT) : Managed File Transfer (MFT) (Wikipedia) Managed Read More
Preparing for Product Development in Process Manufacturing
Combining process industry–oriented product lifecycle management capabilities with process manufacturing–oriented enterprise resource planning ones can help

gmp regulations  for Product Development in Process Manufacturing P.J. Jakovljevic - February 5, 2010 Originally Published - March 10, 2007 As seen in such articles as Product Life Cycle Management in Process or Process Manufacturing Software: A Primer , what the process manufacturing industry lacks in glamour, it certainly makes up for in complexity. Traditionally, manufacturing is divided into two categories: process and discrete (if one is not counting hybrid, mixed-mode environments). Many differences exist Read More
Implementing Medical Manufacturing Technology to Improve Operations and Control Costs
US manufacturers spend over $25 billion every year on product warranty claims. For medical equipment manufacturers, complex government regulations play a large

gmp regulations  Medical Manufacturing Technology to Improve Operations and Control Costs US manufacturers spend over $25 billion every year on product warranty claims. For medical equipment manufacturers, complex government regulations play a large part in the rising costs of warranty. Learn how manufacturing technology can help improve product quality and minimize the burden of warranty costs by creating records that can be tapped by lawyers, or by the companies themselves, when faced with warranty issues. Read More
Getting Your Money's Worth from Fixed Assets Software
Companies that fail to manage fixed assets can have difficulty complying with reporting regulations and complex, changing tax laws, and thus run the risk of

gmp regulations  Your Money's Worth from Fixed Assets Software Companies that fail to manage fixed assets can have difficulty complying with reporting regulations and complex, changing tax laws, and thus run the risk of misstating financial information and making mistakes in tax filings. A complete fixed asset management software solution should have tracking, depreciation, and inventory features, and should also provide the ability to conduct physical inventories of assets easily and reconcile the results to the Read More
Inventory (Out of) Control
In a market as competitive as the chemicals industry, providing high quality products to clients quickly and efficiently while meeting the rigorous regulations

gmp regulations  (Out of) Control In a market as competitive as the chemicals industry, providing high quality products to clients quickly and efficiently while meeting the rigorous regulations enforced on chemicals from formulation to shipment is no easy feat. Many companies struggle with sales forecasting and maintaining and tracking inventory. Many chemical manufacturers are turning to enterprise resource planning (ERP) software systems to add business-wide visibility to inventory control and reduce costly Read More

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