As companies subjected to the scrutiny of the U.S. Food and Drug Administration (FDA) know all too well, it is not enough anymore just to keep and track records and test results. The current crop of calibration software reflects the need for better electronic record-keeping in various process-driven environments, be it to meet federally mandated guidelines or simply to gain more control over automated processes.
For Blue Mountain Quality Resources' customers, which mostly are in FDA-regulated industries such as pharmaceutical and biotech manufacturing, record-keeping requirements first lean toward what they must do. They then look to the company's calibration management software to improve how they work.
Jim Erickson, president of Blue Mountain, contends that Calibration Manager 4's new Satellite module, which was released in June, essentially closes the loop in electronic signature/ electronic record-keeping. Satellite allows users to collect calibration data on notebook PCs and sign off on electronic records in the field or remotely within the plant per 21 CFR Part 11 specifications.
When users "check in" to the master dataset, records are synchronized and automatically updated. All the while, the system maintains an audit trail. The module thus satisfies FDA mandates while enhancing mobile productivity.
Calibration Manager also embodies synchronicity in an enterprise sense by being a Web-based application. "That, in conjunction with it being tied to a Microsoft SQL (Server) database," Erickson says, "has enabled large companies to host it for multiple sites with one location, one implementation. That's really a first for a calibration manager software."
Erickson explains that the software's enterprise capability, offered with the 4e version of Calibration Manager, brings substantial cost savings when validating commercial off-the-shelf software for each user facility as mandated by the FDA. When companies host 4e at a single site, they need only go through the entire validation process there; validation at other facilities is minimized.
