Loftware Spectrum® 2.7 Introduces Configurable Workflow and eSignature Capabilities to Facilitate 21 CFR Part 11 Compliance

Share Article

New Level of Visibility and Control for Validated Label Management

Spectrum2.7Release

Spectrum 2.7

“Medical device and pharmaceutical companies have the unique challenge of meeting complex regulatory labeling requirements while operating in a validated environment.”

Loftware, Inc., the global leader in Enterprise Labeling Solutions, today announced Loftware Spectrum 2.7, the latest release of their 100% browser based solution designed to meet complex labeling requirements. Spectrum 2.7 includes workflow and eSignature capabilities to provide a new level of 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 seamlessly with existing business processes, offers unlimited flexibility to define and manage approvals workflow processes while providing users with complete control, improved visibility and auditability. This powerful 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.

“Reviewers and approvers can receive email notification when they need to take action, and can easily approve or return labels with comments,” stated Loftware Director of Product Management, Scott Johnson. “Users maintain visibility and control because they can see the status of labels as they move through the workflow from creation to approval to publication,” he added.

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 FDA to accept electronic records and signatures in place of paper records and handwritten signatures. eSignatures work within Spectrum’s Application Architect, a powerful 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.

“Medical device and pharmaceutical companies have the unique challenge of meeting complex regulatory labeling requirements while operating in a validated environment,” stated Loftware Vice President of Product Management, Josh Roffman. “Loftware Spectrum has raised the bar when it comes to meeting these challenges; including the need for companies to configure approval workflows and eSignatures to meet their unique business needs.”

Now with Tags for Objects, which allows users to search, sort, filter and report on almost any type of object, Spectrum lets users can organize and easily 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.

The newly introduced Generic Printer Driver framework extends Spectrum’s flexibility to drive printing beyond traditional integrated printing methods. The framework allows users to create a basic XML or image-based driver that will send data natively to any device that will support it. Users now can achieve greater integration of the printing environment, working with XML data for generic printers across a business enterprise, without requiring a label template. This provides a path to integrate historically ‘closed’ systems that only allow basic data interfaces.

About Loftware
Loftware, Inc. is the global market leader in Enterprise Labeling Solutions with more than 5,000 customers in over 100 countries. Offering the industry’s most comprehensive labeling solution, Loftware’s enterprise software integrates SAP®, Oracle® and other enterprise applications to produce mission-critical barcode labels, documents, and RFID Smart tags across the supply chain. Loftware’s design, native print, and built-in business rules functionality drives top line revenue, increases customer satisfaction, and maximizes supply chain efficiency for customers. With over 25 years of industry leadership, Loftware’s Enterprise Labeling Solutions and best practices enable leading companies to meet their customer-specific and regulatory requirements with unprecedented speed and agility.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Maureen Perroni
Loftware, Inc.
+1 (603) 570-4713
Email >
@LoftwareInc
Follow >
Loftware Inc.
Like >
Follow us on
Visit website