SpectraSoft Technologies Limited

STABILITY MANAGEMENT - vACT:STABILITY MANAGER™

INTRODUCTION:

The requirements for establishing the stability of pharmaceuticals and food products are stringent. Representative samples from production batches, critical intermediates as well as package types all need to be tested over the proposed shelf life of the product. Typically many hundreds of products under go stability tests concurrently. The testing of sample along with the results and management of test data forms the major workload of many quality control laboratories.

In general Stability studies are conducted to :

To establish the stability of a product under anticipated storage conditions, which is an essential step towards approving a product for end use.
Provide evidence of the effectiveness or shelf life of a product in controlled environment condition.

Feature List:

Define Stability Plan/Protocol
Sample Inventory
Storage Location Management
Test Master
Test Plan (Specification)
Initial Sample
Result Recording
Usage Decision
Reports / Queries
Approval Process
Multi Division / Multi-Lab support
21 CFR Part 11 Compliance
Escalation Mechanism

Benefits of vACT:Stability Manager™:

Stability Planning enables automated calculation of sample quantities, hence eliminating human errors.
Tracking of samples in the stability chamber to the exact location - Saving time for searching and locating correct samples.
On-Line information of stock on hand and reserve sample quantity.
Automatic reminder through e-mail and / or SMS when tests are due - Ensures that opportunities loss due to missed rests is prevented.
Provides for storage capacity planning
Enables optimum reservation of critical equipment.
Fully compliant to 21 CFR Part 11 including login security, session idle time logout, password expiry and full fledged audit trails of all transactional entries