Camstar Enterprise Manufacturing and Quality Solutions

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IVD Technology - May 2008

Lowering the Cost of Quality for IVD Manufacturers - Breakthrough processes enabled by new technologies can reduce quality costs.

Aberdeen Research Market Alert - May 2008

Enterprise Technology Platform for Manufacturing Operations Management - In March 2008, Camstar Systems, Inc. announced the launch of a re-architectured enterprise platform integrating manufacturing execution, quality management and Manufacturing intelligence into a single interoperable solution. This Market Alert highlights the importance of this launch to Camstar's customer base as well as manufacturers planning to invest in technology solutions for managing manufacturing operations.

AMR Research Alert - May 2008

Medical Device Manufacturers Get Great, Green ROI From MES Implementations - An audience comprising primarily top-tier medical device manufacturers gathered at Camstar’s recent annual user group to present successes and share best practices. Much of the event’s buzz was about the upcoming May 2008 commercial launch of Camstar’s enterprise platform for manufacturing, quality, and intelligence.

Medical Device & Diagnostics Industry - September 2007

Software Systems Breaking Boundaries for Device Makers - Software for medical device operations tends to be divided into well-established, compartmentalized categories. But some firms recently have been trying to break the mold by introducing systems that stretch across two or more of these categories.

Charlotte Observer - July 2007

Camstar Thriving where Few Tech Firms Dare to Go - Why would the software company move its headquarters from the technology-rich Bay Area to come here, an area where tech companies have little history and make up a small part of the region's economy? Yet today, under new leadership, Camstar seems to be thriving in its new home.

Medical Product Outsourcing - April 2007

Turning Wishes Into Commands - Want to Improve Yields? Reduce the Risk of Recalls? Software Makes It Possible.

Manufacturing Business Technology - October 2006

Special Report: Healing Time - Medical products sector attacks regulatory, performance issues with rich systems mix.

Medical Device Link - October 2006

Selecting and Using a Manufacturing Execution System - An effective manufacturing execution system can help drive quality and productivity improvements.

IVDT - September 2006

Leveraging technology for IVDs: Lessons from other sectors - Karim Lokas describes ways that In Vitro Diagnostics manufacturers can learn to align technology with compliance and business initiatives and put manufacturing processes in overdrive.

Start IT Magazine - May 2006

Having the Vision: START-IT’s 2006 CEO VISIONARIES - Camstar CEO Scott Toney Wins Visionary Award.

Medical Device Link - October 2005

Developing Dynamic Device History Records - Deciding between paper and electronic device records may seem obvious. Less obvious are the considerations that go into creating a DHR that is not only functional, but also makes the manufacturing process more efficient.

Medical Device Link - October 2005

Device Makers Access Key Data from a Distance - Monitoring software lets manufacturers tap off-site sources of process and product information remotely.

InMFG Magazine - August 2005

MES: The Big Payoff - Boosting Production and Profits - By connecting enterprise planning systems to automated equipment on the factory floor, manufacturing execution systems pave a promising path to higher productivity and profits.

MPT Magazine - August 2005

Reducing Risk and Cost: Part 1
How do you reduce cost and risk while improving compliance in Life Sciences manufacturing?

MX Magazine - August 2005

Coming Closer: The Future of Integrated Healthcare IT
As the ideal draws nearer to reality, medtech manufacturers should not miss the integration bandwagon.

Pharma Manufacturing - August 2005

How MES Enables PAT A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality.

Quality Digest - July 2005

Electronic Signature Verification: Stay on Track as the FDA Re-examines 21 CFR Part 11
It's been nearly 13 years since the FDA published its first draft of this document in 1992. During the last decade, the FDA published the final rule (1997), released an enforcement policy (1999) and drafted guidances (2001-2002). In 2003, however, the FDA withdrew the enforcement policy and the draft guidance, and reissued a new guidance, leaving industry experts perplexed regarding the FDA's resoluteness to Part 11 compliance.

Pharmaceutical Formulation & Quality - June 2005

Leveraging CAPA with Risk Management and Quality Control
Corrective and preventive actions (CAPA) are regulatory mainstays of the life sciences industry. In the last three years, the majority of life sciences manufacturers have improved or replaced their existing CAPA systems because of evolving FDA regulations.

Pharmaceutical Technology - May 2005

Technology Helps Manufacturers Create a Manufacturing Compliance Platform When technology and business processes align, drug manufacturers become more efficient, leading to faster delivery to consumers of safer, cheaper products. One innovative solution aligns process analytical technology (PAT), Lean Manufacturing, and Six Sigma to create a manufacturing compliance platform (MCP) that could lead to significant improvements in pharmaceutical manufacturing.

RAPS Regulatory Affairs Focus - April 2005

Technology for an Effective Risk Management, Compliance and Enforcement System By successfully leveraging technology and risk management to help their organizations meet compliance and enforcement goals, regulatory professionals will emerge as company and industry leaders.

Copyright 2005 by the Regulatory Affairs Professionals Society (RAPS). Posted with permission on camstar.com. Reprinted from the April 2005 issue of Regulatory Affairs Focus. This article may not be published, reposted or redistributed without express permission from RAPS (www.raps.org) and payment of appropriate fees when applicable. To obtain such permission, send a request to reprints@raps.org.

Pharmaceutical Formulation & Quality - March 2005

PAT Finds Home Outside Manufacturing An automated software solution can help pharmaceutical businesses profitably and effortlessly align quality improvement initiatives and a manufacturing execution system (MES) is the ideal software tool to leverage business process initiatives with PAT.

Apics Magazine - March 2005

Medical Miracles - Adaptable MES heigtens quality and speeds production. Zoll Medical Corporation relies on the InSite manufacturing execution system (MES) from Camstar Systems to speed production and automatically satisfy stringent regulatory requirements.

Pharmaceutical Processing - January 2005

High Quality and Lower Costs Prevail Where PAT and MES Intersect PAT requires a compliance framework such as MES, from which manufacturing and quality can distribute and collect data on a common platform. Benefits can be gained from data that is accurate and accessible, a quality team that is focused on the same critical delivery schedule as manufacturing, and reduced cycle times with higher yields and predictable results.

Medical Design Technology - December 2004

Paperless Manufacturing System The InSite Rapid eDHR is an integrated paperless manufacturing system that helps manufacturers improve operations performance, shorten manufacturing cycle times, and reduce the cost of compliance. It automatically constructs electronic device history records by enforcing complete and correct data at every step. It provides real-time feedback and analysis data that facilitate higher first pass yields and quality. Rapid eDHR is quick to deploy and validate, and satisfies the needs of manufacturers looking for a high return on investment.

Medical Design Technology- November 2004

Leaning Into Six Sigma - Integrating Lean Six Sigma and a manufacturing execution system can help meet regulatory compliance goals. This exclusive report shows how such integration can increase return on investment without compromising quality or efficiency.

Medical Device & Diagnostic Industry - September 2004

Manufacturers Lean to Trim Waste Those who advocate lean strategies tout the savings in labor, space and time on the plant floor and beyond

MX - September 2004

The Manufacturing Edge Creating the advanced IT-based healthcare system of the future with building blocks used in everyday operations

Industry Week- June 2004

Finding The Right Fit - Software responds to different industries, sizes of manufacturers

Pharmaceutical Technology- May 2004

Validation and Compliance

Quality Magazine - February 2004

MES Reduces FDA Compliance Costs

Managing Automation Magazine- January 2004

The New MES Market - Software from ERP and automation vendors is inching in, creating new competition yet introducing capabilities that redefine this space

Pharmaceutical Technology- January 2004

Manufacturing Execution Systems - Moving it to the next level

APICS - December 2003

A Real Time Solution

MSI - December 2003

Real-Time Production Management

The Manufacturer - March 2003

Making Real-Time a Reality

BaseLine - October 2002

Corning Focuses on Customer Data

MSI - September 2002

Grounded in Reality