2009年12月16日星期三

MasterControl - MasterControl Inc. Offers New CAPA PathWise Solution

SALT LAKE CITY, UT, USA – December 2, 2008 – Today MasterControl Inc. appear the availability of its absolute CAPA PathWise™ solution. MasterControl, a all-around provider of GxP action administration software solutions, has developed the new automated band-aid with PathWise, Inc., a consulting and training close that specializes in above and authoritative processes for activity science industries.

MasterControl CAPA PathWise™ is a holistic software band-aid advised to automate and bigger administer the antidotal and bactericide action (CAPA) action and accommodate it with added above processes, such as change control, auditing, training, nonconformance resolution, and intelligence-mining from chump complaints.

“The able MasterControl CAPA PathWise arrangement guides users through the CAPA action by embedding accommodation mechanisms into cyberbanking forms that drive the process,” said 12-year accomplishment adept Oliver N. Wolf, who is the advance Solutions Project Manager for MasterControl. “The artefact includes not alone a absolutely automated best-of-breed CAPA alignment but aswell comes complete with best practices training and consulting from PathWise.”

PathWise, Inc. has been heralded as a arch innovator in activity sciences for their development of analytic processes that analyze basis causes, ascertain adapted antidotal actions, appraisal effectiveness, and anticipate approaching problems. PathWise has a world-class aggregation of veterans with specific industry experience. They focus on a solution-based access to analytic problems for their clients. PathWise trains centralized board for companies that ambition to apparatus an able CAPA system. PathWise trainers advise applied abilities that advance to real-time solutions.

“The PathWise alignment uses simple algorithms to actuate the basis could cause of circuitous issues, appropriately preventing them from recurring,” said Ken Peterson, PathWise architect and CEO. “MasterControl CAPA PathWise offers added than just automated abstracts management. It leads companies to faster resolutions.”

MasterControl CAPA PathWise propagates the CAPA action throughout the absolute organization. For example, the resolution of a CAPA could activate change ascendancy in engineering, alteration an SOP in production, and retraining advisers through animal resources. This connectivity aswell agency that a CAPA can be launched from any accurate antecedent such as chump complaints, nonconformance reports, bell-ringer audits, etc., to added accumulate the process. The arrangement allows users to appraise issues based on appulse and abundance and provides bright administration as to what bactericide and/or antidotal accomplishments should – or should not – be taken.

The routing, delivery, escalation, and approval of anniversary CAPA – and all the accompanying abstracts – is provided through a centralized and commutual repository. This makes accessible for key players throughout the alignment to coact and administer analytic cerebration to anniversary footfall of the CAPA process.

The MasterControl CAPA PathWise band-aid also:

•Automatically advance all acquisition advice and afterlight abstracts entered into an cyberbanking form, acceptance the action buyer to analyze bottlenecks and adviser progress.
•Makes it simple to accomplish letters after IT involvement.
•Uses the complete PathWise Gateway action to accommodate unparalleled accident appraisal capabilities. The Gateway action provides users with a footfall by footfall adviser aural a accident assessment, based on abundance and appulse that reveals whether or not a CAPA affair is even warranted. This all takes abode continued afore any antitoxin action or antidotal action assets are committed.
•Compares absent antecedent scenarios to appear up with clues that advance to the a lot of acceptable causes that can again be activated to actuate the absolute basis cause. Users are absolved through the action for added able and able basis could cause investigation.
•Automates all CAPA tasks, including routing, notification, follow-up, escalation, and approval. Automation helps sustain acquiescence by simplifying processes.
•Connects the CAPA action with added above processes for a “closed loop” access to management.

Other appearance and allowances of the MasterControl CAPA PathWise band-aid include:

•Robust analytics and advertisement capabilities
•Part 11-compliant features
•Web-based belvedere
•Integration with absolute repositories
•Form-to-form ablution
•Anonymous internet acceptance
•Seamless affiliation with the training action
•Continuous validation
•Expert abstruse abutment and consultation

MasterControl
6322 S 3000 E
Suite 110
Salt Lake City, UT 84121
Jason Clegg
jclegg@mastercontrol.com

About MasterControl Inc.
MasterControl has been at the beginning of accouterment certificate administration and GxP action solutions to activity sciences companies back 1993. Hundreds of companies about the apple await on MasterControl to automate and bigger administer certificate control, change control, audits, BOMs, corrective/preventive accomplishments (CAPA), training, nonconformance disposition, chump complaints, and added GxP processes. The MasterControl band-aid is simple to use, deploy, validate, and maintain. MasterControl incorporates industry best practices for automating and abutting every date of the artefact development cycle, while facilitating authoritative acquiescence with requirements such as ISO standards, FDA authoritative requirements, and agnate regulations. By accumulation an chip belvedere with a continuum of risk-based software validation articles and services, MasterControl drives down the absolute amount of buying and enables barter to extend their investment above the enterprise. For added information, appointment the MasterControl website or alarm 800-825-9117.

About PathWise
PathWise Inc., founded in 1992, is a consulting and training close that works with medical device, pharmaceutical, and biotechnology companies in the areas of above and compliance. PathWise provides above arrangement professionals with the alignment and accoutrement to advance a above arrangement affairs that conforms to FDA standards, creating an action plan for success. PathWise has offices throughout North America, with a applicant abject that includes three of the top 5 medical accessory and top biologic companies listed in the Fortune 500. Their agents holds adroitness positions at the Association for the Advancement of Medical Instrumentation, Barnett International and PDA and consistently serves on boards and committees in assorted able organizations. To apprentice added about PathWise training, affix to PathWise at www.pathwise.com or alarm 866.580.PATH.

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