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Software Functionality Revealed in Detail
We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.
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 gmp documentation


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 documentation  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

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Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

Compare Now

Regulatory and Compliance RFI/RFP Template

Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology  

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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 sciences companies, deploying solutions in the cloud may lead to unintentionally violating FDA regulations if the proper steps have not been taken to ensure FDA compliance.

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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 Reinvestment Act of 2009 (ARRA), a.k.a. the Economic Stimulus Plan. The inspiration came from my attendance of the Deltek Insight 2009 user conference last May, where Deltek decided to fill a market need by convening a separate

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Case Study: Align Technology, Inc.


Planning to expand, Align—a medical device manufacturer—identified electronic document management as a vital component of growth. One goal was to reduce the time needed to process change orders, as its current processes were all manual. After the vendor selection process, Align chose a change management solution that offers fully compliant and redundant protection for the company’s data. Learn more about the benefits that helped Align save $250,000 (USD) in administration costs.

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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 offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

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IFCS inc.


Founded in 1993, and located in the center of Montreal's "multimedia city," IFCS, Inc. is a Quebec (Canada)-based firm specializing in the analysis, modeling, design, implementation, and customization of asset management solutions. The company's product line includes solutions for maintenance management, production management, electronic documentation management, and the design of secure, multilingual, transactional Internet sites. IFCS is also an Oracle value-added reseller (VAR).

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Regulatory and Compliance RFI/RFP Template


Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology

gmp documentation   Read More

The Best-kept Secret in the Product Lifecycle Management Mid-market


The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that might change down the track

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HR Compliance: 4 Things Your Company Can Do to Avoid a Lawsuit


Every so often we hear about companies being sued by their former employees for alleged unfair or illegal HR practices. Whether the claims relate to sexual harassment or inadequate compensation, one thing is for sure: they will cost your company money and may even bring about its demise. TEC analyst Sherry Fox looks at four things your company can do to establish best practices in HR and thus avoid damaging HR lawsuits.

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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 conference, Atrion presented a vision and product strategy to their customers that will provide critical regulatory and compliance capabilities needed to support the product life cycle. The conference pointed out the importance of regulatory compliance as an important element of a product lifecycle management (PLM) strategy, and the role that environmental health and safety (EH&S) plays in protecting PLM value.

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Business Process Management: How to Orchestrate Your Business


Business process management (BPM), having evolved over the past fifteen years, has finally reached a level of maturity where vendors are now abolishing functional silos to allow the enterprise-wide flow of business processes. It replaces the old, manual system of coordinating activities in a company and improves functionality and effectiveness through modeling, documentation, certification, collaboration, automation, and compliancy to minimize costly errors.

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