X
Start evaluating software now

 Security code
Already have a TEC account? Sign in here.
 
Don't have a TEC account? Register here.

Discrete Manufacturing (ERP)
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...
 

 fda 21 cfr


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 21 cfr  technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

Read More


Discrete Enterprise Resource Planning (Discrete ERP) RFI / RFP Template

Financials, Human Resources, Manufacturing Management, Inventory Management, Purchasing Management, Quality Management, Sales Management, Product Technology Get this template

Read More
Start evaluating software now

 Security code
Already have a TEC account? Sign in here.
 
Don't have a TEC account? Register here.

Discrete Manufacturing (ERP)
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...

Documents related to » fda 21 cfr

Are You on Track for 21 CFR Part 203 Compliance?


It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance?

fda 21 cfr  Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Read More

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 have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.

fda 21 cfr  customer or conform to FDA requirements. According to FDA’s publication in 21 CFR 820.40, Medical Device Manufacturers are required to have written procedures for the approval and distribution of documents. The approval procedures must ensure that the documents meet 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 mu Read More

Five Must-have ERP Features for Medical Device Manufacturers


In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are turning to enterprise resource planning (ERP) solutions. Discover the five features any medical device manufacturer should look for in an ERP system in order to meet compliance requirements, produce high-quality products, operate efficiently, and maximize profitability.

fda 21 cfr  of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today's solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability. Bringing the Best ERP Solution to the Medical Device Industry Today's ERP software can capture data, validate manufacturing processes, ensure product specifications are met, and provide rapid access to that Read More

abas ERP Partners for Quality Management Software


abas-USA and Pickert & Partner GmbH recently announced a new partnership, which will integrate the Pickert RQM quality management system (QMS) with abas ERP. The integration of these enterprise systems aims to support quality standards through most production-related processes across the entire value chain from the enterprise resource planning (ERP) system to machine controls.

fda 21 cfr  VDA 6.1, VDA 6.4, FDA 21 CFR 11, EN 29001, 9342 EWG, ISO 13485, EN 9001 Aerospace Series, and AQAP 2110. Each of these elaborate standards has specific reporting requirements, data collection devices (e.g., machine readers, calibration devices, spectrometers, and chemical analysis readers), etc.   I am not sure whether any ERP vendor can maintain these standards and, more importantly, keep up with changing standards in a single package. In abas ERP one can look for quality data in inbound receipts, Read More

JBA: Will it remain "@ctive Enterprise"?


In 1999, JBA launched its @ctive Enterprise Series product line, which allows customers to dynamically model and continuously update their business processes. While the merger with GEAC brings some positive prospects, JBA's ambitious R&D pipeline may be jeopardized.

fda 21 cfr  Will it remain @ctive Enterprise ? Vendor Summary JBA International is a global supplier of integrated enterprise management software for midsize companies involved in the manufacture, supply and service of industrial and household goods. Founded in 1981, with headquarters in Birmingham, UK, JBA International is the sixth largest ERP vendor with $480 million in revenue in 1998 (approx. 3% of the global ERP market). The Company has a history of continuous growth since its inception, but fiscal 1998 Read More

Food Safety, Government Regulations, and Brand Protection


Many food companies are investing significant funds in building awareness for their brands in the market, which can pay off amply in competitive, commodity markets. One highly publicized recall, however, can turn an established brand asset into a liability.

fda 21 cfr  and Drug Administration ( FDA ) and US Department of Agriculture ( USDA ), that are responsible for regulating food products. These agencies help to ensure that foods are safe to eat, and that they do not contain any harmful additives. Correct labeling of food products is strictly enforced, and some countries now exercise strict guidelines relating to product advertising. Food control and safety will only increase with the closer linking of food supplies among countries and regions, especially in light Read More

The 7 Deadly Sins of Software Selection


Q: How many doomsday prophets does it take to change a light bulb? A: None. The light is still on. “Knock knock.” “Who’s there?” “The Raptured. SURPRISE!” Thank you, thank you, don’t forget to tip the archangels, I’ll be here all week (according to best estimates). You may have heard recently about Harold Camping, the radio host who predicted that The Rapture would take

fda 21 cfr  7 Deadly Sins of Software Selection Q: How many doomsday prophets does it take to change a light bulb? A: None. The light is still on . “Knock knock.” “Who’s there?” “The Raptured. SURPRISE!” Thank you, thank you, don’t forget to tip the archangels, I’ll be here all week (according to best estimates). You may have heard recently about Harold Camping , the radio host who predicted that The Rapture would take place May 21. Fun fact : Did you know that Harold Camping’s tribulations Read More

RFID in Healthcare--A Whole Industry of Value


This article talks about recent and expected FDA regulations and how RFID can help meet those requirements while improving supply chain performance.

fda 21 cfr  of Value Introduction The FDA is not only responsible for the protection of citizens and consumers, but also is an active partner with industries such as food, pharmaceuticals, medical devices, etc., in pursuit of industry best practices. $49 billion of imports of pharmaceuticals enter this country every year. The pressure is on from consumers and industry to protect their own interests. These represent sometimes conflicting goals of protection. Protect the consumer, yet protect brand integrity and the Read More

Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry


To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

fda 21 cfr  around electronic data, the FDA defined an electronic record as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, or distributed by a computer system. In 1997, the agency issued Part 11 of Title 21 of the Code of Federal Regulations (CFR) to ensure the security, traceability, and integrity of electronic records and electronic signatures. Although 21 CFR Part 11 has been under review by the FDA Read More

Resurrection, Vitality And Perseverance Of Former ERP 'Goners' Part One: Ross Systems & SSA Global Technologies


While an increasing demand for services and incremental purchases of new extended-ERP functionality from existing client base, with a modest ooze of new accounts and even a notable influx of new accounts for distinguished some, may not put the revitalized former ERP losers back on top of the enterprise applications charts, they will likely remain around and not necessarily just to impede mid-market forays of both Tier 1 brethren and the likes of Microsoft.

fda 21 cfr  created by increasingly stringent FDA (Food & Drug Administration) regulations, as it provides the master action plan, templates and test scripts needed to quickly complete the IQ, OQ, and PQ (installation qualification, operation qualification and performance qualification) processes, and clearly defines and thoroughly documents each step in a proven process to predictably achieve and maintain validation. Owing to its focus on Process Manufacturing, Ross continues to invest in industry-specific applicati Read More

ERP &; Distribution Showdown! Oracle's JD Edwards vs. TGI's Enterprise 21


Using our ERP - Distribution Evaluation Center, we compared Oracle's JD Edwards and Technology Group International head-on. For the overall rankings portion, we looked at these vendors' solutions in two basic configurations, with and without back-office (human resources [HR] and financials) functionality. To eliminate any chance of bias and to ensure a level playing field, all 3, 414 criteria comprising all the modules and submodules in the ERP - distribution request for information (RFI) were given equal weight and priority...

fda 21 cfr  &; Distribution Showdown! Oracle's JD Edwards vs. TGI's Enterprise 21 ERP - Distribution Showdown! Welcome to TEC's ERP - Distribution Showdown: Oracle's JD Edwards EnterpriseOne vs. Technology Group International's Enterprise 21 I'm Dylan Persaud, senior analyst at Technology Evaluation Centers (TEC). Today the spotlight is on ERP - distribution solutions, with Oracle's established JD Edwards EnterpriseOne and up-and-coming Technology Group International 's Enterprise 21 going one-on-one in a Read More

Workday 21—All about a New User Experience


Workday releases version 21 of its HR solution with a focus on a new user experience, and much more. Get the details in Raluca's blog post.

fda 21 cfr  21—All about a New User Experience Workday has recently announced a new user experience as part of the 21st release of its solution. The new architectural and visual redesign complement other trendy technologies that the vendor has embraced—i.e., cloud and in-memory database. During the past 5 months, Workday—inspired by the consumer Internet—has worked on applying a minimalistic style to its user experience. In an analyst briefing with me, Joe Korngiebel, vice president of user experience 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 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.

fda 21 cfr  a manner compliant with FDA 21 CFR Part 11 regulations and in a way that supports the organization's specific SOPs. It provides audit trail tracking and reporting in all areas of the ERP system that are FDA significant, including batch records, engineering changes, quality records, inventory status transactions, process instructions and recording of results. The infrastructure approach gives the business control over its approach to compliance. For example, a hard-coded compliance solution might require Read More