The software can help drugmakers keep up with compliance commitments, respond quickly to requests from regulators and improve efficiency, according to Blue Mountain.
The regulatory asset management firm claims to have identified a functionality gap in the software solution market, where asset management traditionally has included separate software for each section: calibration, validation and maintenance.
The company says that the package - Blue Mountain Regulatory Asset Manager - is the first multi-tasking software to hit the market that satisfies the compliance demands of life science industries.
The management software solution brings together information that was previously stored in separate systems, cutting down the risk errors between information stored in multiple systems, according to Blue Mountain. It also reduces redundant data entry and cuts validation costs, it claims.
Blue Mountain says that the US Food and Drug Administration's (FDA) is looking for a more systematic and harmonised approach to asset management. As an example, the FDA has taken a closer look, using a "top-down" approach, at systems in place to control quality through their "quality system inspection technique" (QSIT).
This approach involves the agency reviewing a firm's quality addressing systems, prior to looking at specific procedures.
"By bringing all disciplines of asset management together in a single application, quality control has a single platform to interface with the people who are working on and with the assets. It can be configured to conform to existing business process rules to ensure that quality control is maintained," Bryce Johannes, Blue Mountain director of marketing, told In-PharmaTechnologist.com
"Competitive pressures are causing pharmaceutical companies to take a closer look at the costs of production, looking specifically to eliminate redundancies and improve efficiencies."