SLiM^TM is the first fully integrated Service Management System to combine quality / service best practices through capture of all relevant data to track a product from conception to obsolescence. It is designed to improve efficiency, control and compliance under FDA regulations of day-to-day operations in the medical devices industry.

SLiM Benefits

SLiM^TM provides an approach that - when coupled with strong compliance capabilities - provides the medical devices company the tools needed to succeed today and into the future. Whether service is performed directly or through a third party, the quality and reliability of service reflects directly on the value and reliability of the product - and the company that offers it.

The manufacturer's reputation and future sales are based on maintaining long-term relationships and a high level of trust. SLiM^TM can provide the needed compliance, but also go much further by improving service levels at a reduced cost. Profitability from today's product relies on cost management and compliance.

SLiM is a modular software system that

• Addresses the full-service cycle of a product
• Addresses the business needs (operate as a profit center) in the medical industry
• Provides a highly scalable solution
• Meets the regulatory requirements described in 21 CFR Part 11, 820
• Provides service process control through a closed looped integrated quality system

Service Document Control - ensures that the Service technicians have available and are using the information / documents needed to do their job. This also addresses the regulatory requirements defined in 21 CFR Part 820.

Regulatory Compliance Management - insures that the system meets the compliance requirements as outlined in 21CFR Part 11, and insures the organization passes an FDA or internal audit.

Financial Management - SLiM^TM provides a comprehensive integrated view of the financial picture of the service business on a real time basis.

Validation Kits - Mandatory for an implementation in the medical industry, the Validation Kit reduces the time spent in validation by up-to 60% as compared to manual validation.

Implementation Time & Cost - Our accelerated deployment made possible through pre-established business templates and configurations yields implementation time lines that are 35-40% lower than the industry norm.

SLiM Features

Service Quality Management

• Customer complaints
• Product quality
• RMA
• Nonconformance
• Test Equipment tracking
• Service document control
• Adverse events
• 21 CFR Part-11 compliance

Service Resource Management

• Employee management
• Training & development
• Competency tracking
• Inventory management

Service Activities Management

• Service complaints
• Depot repair
• On-Site service calls
• Clinical support calls
• Service agreement management
• Serial number & lot traceability

Service Financial Management

• Service cost accounting
• By unit
• By customer
• By employee
• PL peporting
• Warranty management

Information at your fingertips

• Service history
• MTBF/failure rate
• Complaint data
• Built in FDA medwatch form
• P&L reports
• Cost reports
• Service Metrics & more .....

Single Comprehensive View - All the information you need to run your business at your fingertips

• Customer activities
• Installed base
• Device history
• Spare parts inventory
• Employee records
• Training records
• Employee competencies
• Service profitability by device

Regulatory Compliance - Templates ensure full compliance with current and future regulatory requirements.

• Operating procedures
• Document control
• Training records
• Device history records
• Product traceability
• Configuration management
• Electronic signature
• Audit trails
• Data security
• Sarbanes-Oxley