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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

fda compliance software erp  ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source : 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 » fda compliance software erp


Drug Pedigree Guidelines and How Software Can Help
Drug manufacturers and retailers are tightening their data collection and reporting processes to meet new US Food and Drug Administration (USFDA) guidelines

fda compliance software erp  Food and Drug Administration (FDA) has issued guidelines covering cradle-to-grave tracking requirements that pharmaceutical companies must comply with for the drugs they produce. We'll look at a brief description of the pedigree guidelines and compliance options. What Are Pedigree Guidelines? Simply stated, the FDA's pedigree guidelines require data to be captured at each stage of the production and distribution process, until the drugs reach the customer or end user. The players principally affected Read More...
Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

fda compliance software erp  with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. 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

fda compliance software erp  Food and Drug 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...
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

fda compliance software erp  compliance. Compliance Strategy The FDA regulations are not a fixed target. Compliance is a key objective for any regulated company, but the requirements to meet this objective are subjective, based upon product, production processes and, perhaps most importantly, your tolerance for risk. Regulatory risk is the risk of being found out of compliance. If you accept very limited risk, your cost of compliance will be high. With more risk, compliance cost is reduced but the potential cost of non-compliance Read More...
Quadrant Software
Quadrant Software@ develops, implements and supports Quadrant HR™. Quadrant HR™ is a user-defined, configurable software and services solution

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Sage ERP X3 (v. 6) for Mixed-Mode Manufacturing ERP Certification Report
Sage ERP X3 (v. 6) is TEC Certified for online evaluation of mixed-mode manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center.

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Global Software
Established in 1981, Global Software, Inc. is a privately owned company located in Raleigh, North Carolina (US). Their analytics suite, which includes

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Sage ERP X3
Sage ERP X3 provides medium-sized businesses with fully integrated functionality in all areas of business for accounting and financial management, purchasing

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Justification of ERP Investments Part 1: Quantifiable Benefits from an ERP System
Studies that surveyed manufacturers about the impact of ERP systems on firm performance indicate that company size and industry do not affect the results

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Dynacom ERP (v. 11.3) for ERP for SMB Certification Report
Dynacom Enterprise is now TEC Certified for online evaluation of enterprise resource planning (ERP) for small to medium business (SMB) solutions in the ERP

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VDoc Software
A subsidiary of the Axemble Group, a holding company with extensive experience in the small to medium business (SMB) market, VDoc Software is an independent

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The Complete Buyer's Guide for Payroll Software
When selecting and deploying a new payroll software solution, there are many factors to take into consideration, including timing, data transfer and conversion,

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Enterprise Software Selection Guide
Selecting an enterprise software solution takes time, energy, and resources. During the selection process, vendors present their products and services in the

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