Validated Label Management [New Products]

Validated Label Management [New Products]

Loftware Inc. has introduced Loftware Spectrum 2.7, the latest release of its browser-based solution designed to meet complex labeling requirements. Spectrum 2.7 includes workflow and eSignature capabilities to provide visibility and control for managing labels in highly regulated industries, including chemical and food & beverage, and facilitates 21 CFR Part 11 compliance for labeling in the medical device and pharmaceutical companies.

Spectrum’s new configurable workflow framework, which integrates with existing business processes, offers flexibility to define and manage approvals workflow processes. This new capability allows users to configure workflow steps to meet their unique requirements by defining transitions, and approval roles. Also, multiple workflows can be designed to support various label types or to match different approval processes.

With Spectrum 2.7 users can define and add any number of workflow steps that can now be controlled by an eSignature. This enables Title 21 Code of Federal Regulations (CFR) Part 11 compliance, which allows the FDA to accept electronic records and signatures in place of paper records and handwritten signatures. eSignatures work within Spectrum’s Application Architect, a feature that enables users to create and manage complex applications, eliminating the need for customers to build their own user interfaces. Within the applications users can permanently associate signatures with labels and ultimately provide a formal and verifiable approval of a label.

Now with Tags for Objects, which allows users to search, sort, filter and report on almost any type of object, Spectrum lets users organize and assign tags to these objects in the system, simplifying label management. Using tags, which provide additional metadata on objects that can be used by the Spectrum Business Rules engine, provides a path to extend business logic to all aspects of the system.  For example, a tag can be set to mark a user’s region, so when they log into their printing environment the tag will be used to properly configure their user interface including the selection of the proper language.

Loftware Inc.

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