Quality systems validated

Smarttech Consulting Services, a leading provider of technology and consultancy for enabling regulatory compliance, has entered into an agreement with Mastercontrol.

Smarttech Consulting Services, a leading provider of technology and consultancy for enabling regulatory compliance, has entered into an agreement with Mastercontrol.

Under the terms of the agreement, SmarttechCS will provide direct support with professional management services, including training and support for marketing, implementation, and integration of Mastercontrol's Quality Management system, a web based platform for the management and control of Documents, Employee Training , business processes such as Corrective and preventative actions (CAPA) ,Change Control ,Customer Complaints, Auditing and Calibration and Maintenance.

"With Mastercontrol, companies can easily deploy and validate a Quality System.

As standardisation using corporate intranet/web enabled solutions increases, more companies are looking for assistance to implement controls enabling better Collection, Collation, Collaboration and Compliance" said Adrian Carter, director for SmarttechCS.

"We were chosen by Mastercontrol because of our experience within the Life Science Pharmaceutical industry with solutions that enable regulatory compliance." Greg Beeber, VP Global Alliance for Mastercontrol, says "the need for a company such as SmarttechCS to act as a distributor grew out of the increase in European demand for our Pharmaceutical applications.

This is especially important where a company is addressing regulations such as FDA's 21 CFR , SEC Sarbanes-Oxley SOX404 and ISO/IEC 17799, Process Analytical Technology (PAT) ASTM E55 and also the EMEA EU Annex's and Orange guide , ICH Q8, ICH Q9, ICH Q10, , ISO 9000 ,14001,13485 medical devices, BS 6079-1 project management where separate people, departments or sites are collaborating and sharing information.".

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