Compliance in-a-box™ Solution

Pre-Build intranet

Best compliance practices embedded in the solution to save time and money

• Corporate branding
• Information architecture foundation established
• Enterprise, departmental, and project space structure

Workflow and Process Management

Content life cycle, collaboration, and processes will be supported by state-of-the-art technology

• Simple graphical tools
• Users can create their own workflows
• Embedded business rules

Electronic Document Management

Applying best practices in electronic document management:

• Store, organize, access, collaborate, and publish
• Rich features to manage your documents
• Life cycle management
• Content types and metadata used to manage processes
• Quick view of document statuses

Electronic Forms

Integrate Adobe reader forms within your Compliance iIn-a-box™ solution:

• Paperless enterprise ready
• Submit data from PDF forms directly to your compliance solution
• Implement sophisticated business logic

Outlook Synchronization and Integration

Bring your compliance solution closer to people within Outlook

• Allow users to edit, add, and delete content
• Enable users to work online or offline
• Synchronize your calendar, task list, project statuses, and document library

Mobile Integration

Access your user collaborations, work, and content on any mobile

• iPhone and mobile integration (option for Blackberry)
• Make your content available in real time
• SMS alerts

Customer Complaints

Record the problems reported by your customers, employees or suppliers. Our complaints management function helps you document product performance reports. You can use the complaint reports as a way of evaluating customer satisfaction.

Advanced Search and Findability

Quickly retrieve, manipulate, and start working with data

• Full text search
• Metadata and properties search
• Smart search results

Compliance Support

Most compliance solutions share similar key requirements; the differences lie in the details. Managing processes, ensuring content integrity, and keeping track of activities are the key requirements. Our solution will help you comply with the following standards:

• ISO 9001
• ISO 13485
• AS9100
• TS 16949
• ISO SQF 2000/22000

Collaborative Portal

Will help you to quickly access your content, tasks, and process steps from a contributor, management or reader view

• View the content based on your security profile
• Allows you to identify completed and non completed tasks
• Retrieve content, tasks, and processes based on specific metadata

Process Gaps

Document any variances from standard practices and procedures. History management allows you to keep track for validating the approval process when a variance occurs.

Corrective & Preventive Measures (CAPA) System

Create and generate corrective action reports (CARs). Use the central database to record actions taken to correct and/or prevent quality failures and to analyze and correct undesirable quality conditions. The CAR process, CAR verification, and the CAR supplier all follow a traditional “8D” model.

Nonconformity Monitoring

Record nonconformities associated with your products. Identify, isolate, control, and analyze nonconforming material.

Control Documents and Change Management

A fully functional system for managing control documents and ensuring authorization of modifications.

Supplier Guide

A primary list of all your approved suppliers. Control and evaluate the quality performance of your suppliers.