Packaging Solutions Management

Highlights

Food and Drug Administration regulations require that packaging lines perform fully validated and reconciled inspections to prevent mislabelling incidents. Pharmaceutical companies, medical device firms and other such companies have found that it is easier and cheaper to implement systems to meet the mandates of current Good Manufacturing Practices than face the possible consequences of non-compliance. A well-designed documentation system ensures that quality standards are met routinely, provides immediate access to well-organized data, and tracks the approval process for regulatory compliance. Cimage NovaSoft GMP from Cimage NovaSoft is an integrated document management and workflow system that helps regulated companies gain rapid document and information access, and improve quality and flow of information, with security and revision control assured every step of the way.

Specifications Management

A specification, as the primary description of a package, contains both required information and areas for optional data. Cimage NovaSoft GMP  integrated electronic forms capability lets you create specification forms, input data, and retrieve information by sorting on any field in the form. Such as part number or expiration date. Fields can be restricted to drop-down menu options, open to variable input, etc. Specification sheets and other documents can be organized into folders to match your working environments.

Label Management

Since label printing errors account for a large percentage of recalls, changes to packaging labels, whether major or minor in nature, should be managed through documented review and approval processes. With Cimage NovaSoft GMP, change request workflows, whether structured or ad-hoc, may be easily created using drag-and-drop icons. Cimage NovaSoft GMP notifies you via e-mail when a workflow document is in your in-basket and launches the appropriate application, be it review, approve, edit or redline. With time-trigger notifications, bottlenecks can be readily identified. Response and approval threshold voting, sharable tasks, and serial and parallel tasks help shorten cycle times while maintaining full control of the change process for the labels and other documents.

Package Drawing Management

All documents, including your package drawings, whether stored in electronic format or in hardcopy, can be managed using Cimage NovaSoft GMP makes it easy to access, store and track any type of document, including CAD drawings, business and technical documents, spreadsheets, electronic forms, raster images, audio and video. Complex packaging component specifications can be structurally managed in the system through a tool known as logical documents. Each component of packaging can be treated as a separate document file and these files can be collated and linked in the logical document, a separate revision controlled document.

Standard Operating Procedure (SOP) Management

SOPs contain step-by-step instructions that are consulted daily in order to ensure that tasks are reliably and consistently completed. Cimage NovaSoft GMP's extensive document management and search capabilities give you rapid access to SOP information. Since all documents are under full distribution and revision control, the correct version is always available upon request. Relationships can be established between documents using cross-references so that you can link, for example, SOPs with other relevant SOPs. And, Cimage NovaSoft GMP's open architecture and compliance to standards lets you integrate with other applications in your business, such as your Manufacturing Execution System (MES) for electronically driven manufacturing instructions and batch records

Current Good Manufacturing Practices (cGMP) Compliance

Strict control of packaging information is critical for cGMP compliance. Cimage NovaSoft GMP workflows include an electronic signature component as well as a full audit trail capability that tracks time and date stamps, action performed, work files, redlines, and other historical data required for regulatory compliance. Access privileges are controlled through a multi-level security schema that extends to the document level.

The Extended Enterprise

In today's competitive environment, many companies contract out for component manufacture, packaging or even full product manufacture. These contractors must adhere to the same regulations and ensure that the information is recorded, tracked and passed to the company distributing the product. By allowing access to Cimage NovaSoft GMP from the multiple sites you can treat these contractors as extensions of your company, with totally integrated document management.

Some of the documents that Cimage NovaSoft GMP manages:

• Standard Operating Procedures
• Product drawings
• Label graphics
• Master change control forms
• Product and packaging specifications
• Label specifications
• Document change control forms
• Quality assurance procedures

Some of the functions that are performed with Cimage NovaSoft GMP:

• Packaging specification query
• Specifications repository
• Electronic signature
• Security by user, folder, document and group
• Label change approval
• Compliance audit tracking
• Management of change
• Drawing and document redlining
• Packaging specifications version control
• Packaging and label cross-referencing