Home
 > search for

Featured Documents related to »  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 Read More

Discrete Manufacturing (ERP)
The simplified definition of enterprise resource planning (ERP) software is a set of applications that automate finance and human resources departments and help manufacturers handle jobs such as or...
Start evaluating software now
Country:
 Security code
Already have a TEC account? Sign in here.
 
Don't have a TEC account? Register here.

Documents related to » gmp documentation


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

gmp documentation  good manufacturing practices as GMP. Collectively, these are referred to as GxP. 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 documentation  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
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

gmp documentation  FDA's Good Manufacturing Practice (GMP) and the European ISO standard, Align needed two full-time staff members in document control to manage compliance. Given the company's forecasted growth, executives expected Align would need a total of four full-time employees within two years. It was abundantly clear to Yost that Align needed to migrate from its manual, paper-based documentation and change management processes to a comprehensive and automated document management system. Solution Align went through Read More
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 documentation  EU Directive 91/356 (EU GMP Guideline)—this directive 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 Read More
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

gmp documentation  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). Read More
Regulatory and Compliance RFI/RFP Template
Design for Compliance,Management of Hazardous and Controlled Substances,Regulatory and Compliance Documentation,Managing Recyclables and Controlled

gmp documentation  and Compliance RFI/RFP Template The Regulatory and Compliance RFI/RFP Template lists and describes 406 features and functions found in Regulatory and Compliance software solutions. This Regulatory and Compliance Template can help you save time, control costs, and communicate clearly with vendors at nearly every stage of your Regulatory and Compliance software selection projects. Features and functions included in this Regulatory and Compliance Template: Design for Compliance Management of 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

gmp documentation  Best-kept Secret in the Product Lifecycle Management Mid-market In the past decade or so of our coverage of numerous topics in the enterprise applications space, every now and then, we come across a vendor whose value proposition, product offering, and install base deserve much more credit and awareness than IT pundits acknowledge. One example of this is privately-funded Omnify Software , the Andover, Massachusetts, (US)-based provider of product lifecycle management (PLM) solutions. The vendor’s Read More
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

gmp documentation  Compliance: 4 Things Your Company Can Do to Avoid a Lawsuit The human resources (HR) departments of most organizations today have assumed more responsibilities, not the least of which is ensuring compliance with labor and employment regulations. These include having fair employment practices, ensuring workplace safety, and maintaining up-to-date records, among many others. And those businesses operating on a global scale must not only continuously review their practices, policies, and procedures for 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 documentation  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 with Read More
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

gmp documentation  Process Management: How to Orchestrate Your Business Introduction Companies used to coordinate activities through the company manually. This resulted in inefficiency and errors in the operational process and often led to difficulties in improving the process itself. Organizations are increasingly focusing on the implementation of business process management (BPM) solutions for the purpose of improving functional efficiency and effectiveness in their core business processes. Evolution of BPM Read More
Top Business Objectives When Adopting PLM
This article presents research findings on business objectives to adopt PLM based on software selection projects and surveys conducted by TEC. Drawing and

gmp documentation  Business Objectives When Adopting PLM Although product lifecycle management (PLM) can help business organizations achieve a variety of goals, some benefits of adopting PLM are more frequently sought than others. Research focusing on business objectives that PLM users have in mind prior to evaluating specific PLM solutions demonstrates that drawing and product documentation management, product collaboration, and engineering change management are among the most popular areas on a PLM buyers’ priority li Read More
Modern ERP Processes Behind Historic Scotch Whisky
The whisky industry is an example of a process industry where it is impossible to accurately predict demand for the final product. Goods stocked must also be

gmp documentation  ERP Processes Behind Historic Scotch Whisky - June 2, 2006 Whisky Deep Dive The whisky industry is an example of a process industry where it is impossible to predict what consumer demand will be when the product is ready for delivery. It is also an industry where companies must meticulously account for goods stocked as intermediates (partially finished) and as bulk goods (both finished and partially finished). A good example of how an enterprise applications vendor addresses this microvertical is Read More
Ideabytes Inc
Model Based Testing (MBT) Services provided by Ideabytes @ automates the creation of test cases, at a guaranteed 50% or better, of current test creation time

gmp documentation  Inc Model Based Testing (MBT) Services provided by Ideabytes – automates the creation of test cases, at a guaranteed 50% or better, of current test creation time & costs. Services are based on Conformiq Designer, where the SUT (System Under Test) is modeled, connected to the existing test harness, and test cases generated in any scripting language(s) at the touch of a button. In addition to being more efficient, Conformiq Designer provides increased coverage, automated documentation as well as Read More

Recent Searches
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Others