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
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

gmp documentation  digitize good manufacturing practice (GMP) tasks, standard operating procedures (SOPs) and work instructions. They can also enable corrective action/exception management, Hazard Analysis and Critical Control Point (HACCP) monitoring procedures, and also orchestrate high-level processes and manage data between various disparate systems and empower domain experts to solve production problems immediately on the shop floor. For more information on BPM, see TEC’s earlier articles entitled Business Process 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
The CyberAngel: Laptop Recovery and File Encryption All-in-One
Relevant Technologies took the CyberAngel into our labs to test it for our acceptability rating. It worked as advertised, and had more features than expected.

gmp documentation  CyberAngel: Laptop Recovery and File Encryption All-in-One Background According to the Computer Security Institute's 2003 Computer Crime and Security Survey, theft of private or proprietary information created the greatest financial losses for the survey respondents. If you are a medical institution, government agency, or financial institution, information theft can result in violation of patient privacy regulations, loss of customer credit card numbers, unauthorized financial transactions, or Read More
How Global Trade Management Can Assuage Your International Trade Worries
Globalization has lost its novelty. For most goods-driven enterprises it has become a matter of fact, just to stay in the game. However, the level of complexity

gmp documentation  Global Trade Management Can Assuage Your International Trade Worries Globalization has lost its novelty. For most goods-driven enterprises it has become a matter of fact, just to stay in the game. However, the level of complexity that doing business globally entails can be daunting for professionals in charge of overseeing the supply chain—especially when the business needs to be nimble to keep ahead. Nimble can be painfully complex, but it doesn’t have to be difficult. That’s where global trade 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   Read More
FinancialForce Accounting Summer ’12 Bridges Salesforce Service Cloud and Accounting
FinancialForce Accounting Summer ’12 is launched just in time for the Dreamforce 2012 conference. FinancialForce Accounting has been extended to work with

gmp documentation   Read More
A Made2Manage Systems Customer Profile: The Story of Chemtech Plastics Inc.
Chemtech, a plastics injection molder, experienced doubled sales, achieved a 99.7 percent on-time delivery rate, and generated time savings and process

gmp documentation   Read More
Writing Cost-effective Documentation for Software Systems
As a business employing IT, you may have encountered situations where the software application you purchased didn’t come with a help file. With no time to write

gmp documentation  Cost-effective Documentation for Software Systems As a business employing IT, you may have encountered situations where the software application you purchased didn’t come with a help file. With no time to write complete documentation yourself and no budget to hire a professional technical writer to do it for you, what do you do? By applying the basic principles of cost-effective documentation, your business can develop impressive documentation quickly—for a minimal cost. Read More
What Is Outsourceable and What Is Not
Product engineering outsourcing (PEO) has evolved over the years. The process, from initiation to the closing phase, vary depending on the product and on the

gmp documentation   Read More
Compliant Manufacturing Operations in Life Sciences Companies: Compliant Operations to Lead the Competition
For many life sciences organizations, a key impediment to compliant manufacturing operations remains the disconnect between enterprise and plant systems. This

gmp documentation  consistently. Ensure Compliance with GMP For a life sciences company, compliance with GMP and validation of that compliance is critical to the development and delivery of quality products and responsible, sustainable corporate profitability. Whether at the product level or the process level, regulatory noncompliance can affect your company through fines, penalties, negative publicity, loss of customers, or the prohibition against selling your products in the market. Manufacturing controls play an Read More
How to Start a No-fail Project, Part 3: Planning for Success
An estimated two-thirds of IT projects aren’t completed on time or budget, while 15 percent are cancelled entirely. But your IT project doesn’t have to be a

gmp documentation  to Start a No-fail Project, Part 3: Planning for Success Logic Software is a leading custom software development and outsourcing company in its field.Some of the World's most successful Independent Software Vendors. Source : Logic Software Resources Related to How to Start a No-fail Project, Part 3: Planning for Success : Information Technology (IT) (Wikipedia) How to Start a No-fail Project, Part 3: Planning for Success Project Management is also known as : Project Management Application , Project 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