Spectrum

SPECTRUM is industry standard software to monitor manufacturing through timely measurement of critical quality attributes to ensure consistent product quality. SPECTRUM is a 21 CFR Part 11 compliant software to help ensure consistent product quality. It also ensures compliance to internal controls and standard operating procedures (SOPs). It offers users the ease to precisely monitor various quality parameters of end-to-end manufacturing process.

Spectrum’s software architecture gives complete flexibility to users to configure the application according to their specific needs. The scalability provides opportunity to use SPECTRUM in an integrated environment or deploy its different modules independently. Its user-friendly interface minimizes extensive time and resources required to deploy the application in a real time environment.

Spectrum provides intelligence to rectify the problems before they hamper the quality by way of converting data into meaningful information flowing through the value chain.

SPC is an integral part of Spectrum. It provides efficient means for acquiring information to facilitate process understanding, achieve continuous improvement, share information and knowledge – to improve product quality and achieve total quality management (TQM).

Its various modules include LIMS, Process Control, Stability, Instrument interfacing, Calibration, Lab Inventory and Customer Complaint Tracking.

Regulatory Compliance

• FDA 21 CFR Part 11 Compliant
  
• Validated Software
  
• IQ, OQ & PQ in deliverables

Audit Trails

System provides secured Audit Trails which independently record the date and time of operator entries and actions that create, modify or delete electronic records. These trails also indicate:

• The Change (Insert, Update, Delete)
  
• Reason for Change
  
• User ID
  
• Workstation
  

Electronic Signatures

Each user has an associated Electronic Signature to be the legal binding equivalent of the user’s handwritten signature.

System clearly indicates the Name of the signee, Date and Time when the signature was executed with the meaning (such as Decision, Checked by etc.) - wherever Electronic Signature is applied/printed.

SOP Compliance

SPECTRUM follows corporate standards to effectively monitor the Product Quality according to defined procedures.