Medical Devices Document Management

Highlights

Significant changes are occurring in medical device regulatory activities, including implementation of new post approval tracking procedures, authorization of civil penalties against manufacturers, plus more stringent requirements for pre-approval clinical testing. 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 is an integrated document management and workflow system that helps medical device manufacturers gain rapid document and information access, and improve the quality and flow of information, with security, revision control and audit trails assured every step of the way.

Device Master Record (DMR) Management

A DMR includes device specification, production process specification, quality assurance procedures and specifications, and packaging and label specifications. Efficiently managing DMRs is key to regulatory compliance. Cimage NovaSoft GMP's extensive search capabilities provide rapid, consistent access to your most important documents. Cross-references allow you to establish relationships between your documents so that, for example, a DMR can be tied to a record of manufacture. It makes it easy to access, store, and track any type of document, including business and technical documents, spreadsheets, CAD drawings, electronic forms, raster images, audio and video. And the logical document feature lets you create a DMR and prepare it for publishing by organizing a group of documents as a single entity

Device History Record Management

In traditional manufacturing environments, notebooks are used to record data entries related to materials, equipment, and approval signatures during device manufacturing. With Cimage NovaSoft GMP, electronic forms may be created to ensure that all information is documented while performing a procedure. Its open architecture and compliance to standards lets you integrate it with other applications in your business, such as your Manufacturing Requirements Planning (MRP) system. In this way, you can link your MRP orders with the device history forms which must be completed on the manufacturing floor.  Cimage NovaSoft GMP also allows you multiple options for maintaining bills of materials that can be stored in one location and accessed by engineering and manufacturing alike

Current Good Manufacturing Practices (cGMP) Compliance

Control of medical device information through a product's life cycle is required for regulatory compliance. 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 email when a workflow document is in your in-basket and launches the appropriate application, be it review, approve, edit or redline. With time-triggered notifications, bottlenecks in the process can be readily identified. Forms, e.g. change request forms or deviation forms, can be managed through workflows as well. And forms are under revision control.

Documenting the rationale for responsible decision making is integral to the philosophy of cGMP. Cimage NovaSoft GMP documents are under full distribution and revision control, letting you demonstrate that the correct version of every document is available upon request. And, 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 levels are controlled through a multi-level security schema that extends to the document level.

Training Record tracking using Forms Capability

Employee participation in, and access to, training is essential for quality control. Cimage NovaSoft GMP's integrated forms capability lets you create forms to manage training records and thus verify and control compliance to cGMP regulations. Information can be retrieved from forms by sorting on any field, such as employee or job function. Fields can be restricted to drop-down menu options, open to variable input, etc.

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 and process drawings
• Device history records
• Master change control forms
• Investigation reports
• Device master records
• Quality assurance procedures
• Product and process specifications
• Packaging specifications
• Document change control forms
• Deviation forms
• Work tickets
• Testing procedures and results
• Material safety data sheets

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

• Electronic signature
• Process specification cross referencing
• Compliance audit tracking
• Specifications Repository
• Device history record archival and query
• SOP change approval
• Security by user, folder, document, and group
• Management of change
• Drawing and document repository
• Device master record version control