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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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Documents related to » gmp documentation

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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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 processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

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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 differences between the two related software categories. Microsoft, for example, informally demarcates the Microsoft Windows Workflow Foundation (WF) focus on "internal processes" from Microsoft BizTalk Server's "external BPM" use. Namely

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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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EDI: Top 5 Mistakes to Avoid When Buying EDI Integration


Your business has a better chance of withstanding the challenges of difficult economic times if it can respond quickly to change, provide accurate data, and fulfill demand in a timely way. Electronic data interchange (EDI) can help give you this competitive edge. But to make EDI work, you need to know the five worst mistakes to avoid making when you embark on an EDI integration project in your small to medium business.

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PHP Code Design


Interactive web sites are event-driven. With each user click, a menu selection or keyboard action initiates a thread of execution that runs many lines of code. Many Web projects start as small code snippets gathered from open source sites, but as the web site grows, new developers are added to the mix. Without design and documentation tools, the project can become unmanageable, unreliable, insecure, and costly to expand.

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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

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Nujira Selects and Implements Omnify Software PLM


The competition in the product lifecycle management (PLM)/product data management (PDM) software space is cutthroat, but some incumbent mid-market vendors are holding their ground—for example, Omnify Software, a provider of Web-based PLM software for discrete manufacturers (often using a mixture of electrical and mechanical components). Omnify has announced its latest Empower PLM implementation

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ADP and Kronos Help Customers Adapt to the Affordable Care Act


In an effort to help organizations tackle the new requirements of the Affordable Care Act (ACA), ADP has launched a Health Care Reform section on ADP.com while Kronos has released an eBook, Navigating the Affordable Care Act: An Employer’s Guide to Managing Costs and Compliance in an ACA World. New challenges presented by the ACA may affect the following: payroll processing

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Service Productization


Productization of services is accomplished by associating tangible features with intangible service offerings. Tangible features may take the form of personnel, collateral, methodologies, pricing, facilities, or other attributes. Automation tools like enterprise service automation, database, and project management tools serve as enablers to service productization. By associating tangible features with intangible services, the professional services firm can build client confidence.

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