posted on 1/13/2012 3:24:13 PM
Avid Bioservices has selected Blue Mountain Quality Resources’ Regulatory Asset Manager to automate record-keeping, workflow, and change management within its manufacturing facility.
Driven by quality mandates and government regulations, Avid Bioservices found that it had to upgrade its existing calibration management software to a full-blown enterprise asset management (EAM) system that could serve as a better system of record for its manufacturing facilities.
With Blue Mountain Quality Resources’ Calibration Manager already in-house, the company, which specializes in services for the biotechnology and biopharmaceutical industries, has decided to upgrade to Blue Mountain’s Regulatory Asset Manager (RAM), which is said to manage the maintenance and validation processes of assets as well as calibration.
After a software evaluation, Avid decided that the RAM EAM package was able to meet its compliance requirements while enabling the company to maintain high productivity, Avid officials said.
According to Blue Mountain, the RAM EAM software is designed for life-sciences companies, helping them to balance current Good Manufacturing Practices (cGMP) with profitability. The suite includes the ability to automate maintenance work management, execute electronic work requests and work plans, integrate spare parts inventory, handle purchasing, and manage vendor and service contracts.
This system is designed with pre-configured forms, data fields, and workflows, based upon industry standards and best practices and procedures, the company said.
“The Blue Mountain template solutions and services streamlines the implementation process and reduces overall project costs dramatically,” said Blue Mountain president Jim Erickson in a statement.
Avid plans on utilizing all aspects of the RAM EAM software, including the service event system, cGMP record-keeping, and automated workflows, as a way to move its calibration, maintenance, and validation and change-management activities to a primarily electronic and paperless system.
“We were looking for a proven cGMP-compliant asset and process management software solution to facilitate record-keeping and regulatory inspections, as part of the high-quality biomanufacturing services we provide for our clients,” said Nick Ferguson, Avid’s associate director of IT, in a statement. “Blue Mountain’s experience and leadership in the biotechnology industry, combined with their comprehensive software products and services, make them the right business partner for us.”