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Spectrum > Introduction

Introduction

Spectrum is an FDA 21 CFR Part 11 compliant software solution that helps to ensure consistent product and process quality, resource optimization and reduction of variation. It also facilitates compliance to a company’s internal and external controls and standard operating procedures (SOPs). It offers users the ease to precisely monitor various quality parameters at every stage of process and manufacturing.

Spectrum is capable of variation monitoring on each process event and against each key performance indicator (KPI) in context to its location within the business process, in relation to its stage within each process and against both internal and external standards.

Spectrum is scalable across different processes and geographical locations. This scalability provides the opportunity to use Spectrum in an integrated environment, or to deploy its different modules independently. Its user-friendly interface minimizes the time and resources required to deploy the application in a real-time environment.

Spectrum ensures that operational and raw material inputs are predictable through adequate quality control and quality analysis through advanced SPC tools.

Spectrum includes the following modules:

• LIMS
  
• Stability
  
• Instrument Calibration
  
• Process Monitoring
  
• Lab Inventory
  
• Reagents Management
  
• Complaint Tracking
  
• Dispensing

Spectrum software’s architecture provides complete flexibility to configure the application according to your organisation’s specific needs.

Designed with a modular structure and configurable approach, Spectrum follows the rules and values established in parameters defined by the user in accordance with their requirements and procedural manuals. Thus clients can easily configure and adapt Spectrum according to their specific needs and context.

Spectrum provides comprehensive security mechanism, whereby access rights of each user can be defined based on their responsibilities. Spectrum also provides an unalterable audit trail to maintain complete history of user actions. It also provides an electronic signature facility to authenticate the necessary approvals in a controlled work flow environment.