ScienTek Software, Inc.

From LIMSWiki
Jump to navigationJump to search
ScienTek Software, Inc.
Type Incorporated
Industry Laboratory informatics
Headquarters Tustin, California, United States
Number of locations 1
Area served Worldwide
Products iStability LIMS

ScienTek Software, Inc. is an American corporation that develops, supports, and markets laboratory information management system (LIMS) solutions tailored to pharmaceutical stability testing programs and stability test management. Its most well-known products are iStability® LIMS and STABILITY SYSTEM. The company’s clients include pharmaceutical, biotech, medical device, animal health, cosmetic, and consumer companies.[1] The company also develops and markets eStability Suite, software for electronic submission of stability data to the FDA, and iStability MKT, a mean kinetic temperature calculator.[2]


Technology and products

iStability LIMS

iStability LIMS is a laboratory information management system (LIMS) tailored for pharmaceutical stability testing programs and stability test management. It is web-based, manages stability test schedules, generates reports, and supports FDA/ICH recommended statistical data analysis methods for stability data.[3]

iStability LIMS generates reports[4] such as:

  • data tables in FDA recommended format
  • charts with stability data, regression line, and confidence curve
  • certificates of analysis.

iStability LIMS performs statistical data analysis[5] on stability data including:

  • shelf life predictions
  • poolability determination
  • processing accelerated stability data using the Arrhenius equation.


Product: iStability LIMS
Sample, inventory, and data management
Sample login and management?Y[1]
Sample tracking?Y[1]
Sample and/or result batching?
Task and event scheduling?Y[1]
Option for manual result entry?Y[1]
Multiple data viewing methods?Y[1]
Data and trend analysis?Y[1]
Data and equipment sharing?
Customizable fields and/or interface?Y[1]
Query capability?Y[1]
Import data?Y[1]
Internal file or data linking?
External file or data linking?Y[1]
ELN support or integration?
Export data to MS Excel?Y[1]
Raw data management?
Data warehouse?Y[1]
Deadline control?
Production control?
Project and/or task management?Y[1]
Inventory management?Y[1]
Document creation and/or management?Y[1]
Case management?
Workflow management?
Specification management?Y[1]
Customer and supplier management?
Billing management?
Quality, security, and compliance
Regulatory compliance?Y[1]
QA / QC functions?Y[1]
Performance evaluation?
Audit trail?Y[1]
Chain of custody?
Configurable roles and security?Y[1]
Data normalization?
Data validation?Y[1]
Data encryption?
Version control?
Automatic data backup?
Environmental monitoring?
Reporting, barcoding, and printing
Custom reporting?Y[1]
Report printing?Y[1]
Label support?Y[1]
Barcode support?Y[1]
Export to PDF?Y[4]
Export to MS Word?Y[4]
Export to HTML and/or XML?
Fax integration?
Email integration?Y[1]
Base functionality
Administrator management?Y[1]
Instrument interfacing and management?
Mobile device integration?
Alarms and/or alerts?Y[1]
Work-related time tracking?
Voice recognition system?
External monitoring?
Web client or portal?Y[1]
Online or integrated help?Y[1]
Software as a service delivery model?
Usage-based cost?
Industries served
biotechnology, chemical, cosmetic, medical device, pharmaceutical, veterinary


Additional information