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iLabs™ is an enterprise Laboratory asset management application, which also provides digital audit trail in accordance with 21 CFR Part 11 and EU GMP Annex 11 standards, while saving your team time and money in managing your laboratory materials, instruments and equipment.
It provides following critical features to help Indian Pharmaceuticals Laboratories:
By 2012 onwards, US FDA came down hard on Indian Pharmaceuticals asking Digital Data integrity in R&D & QC laboratories and Good Manufacturing Practices in plants. The 21 CFR Part 11 standards require that the audit trails produced is secure, computer-generated and time-stamped to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit trail tells 'who did what, to your records and when'. iLabs automatically creates this audit-trail for your laboratory assets and its usage. It demands two digital identifications (such as unqiue login and employee id barcode) before it allows any of the data being added or modified. No data ever deletes from Database, as required by these standards.
One of Iconic Indian Pharmaceuticals was affected by FDA shutting their plant and advising them digitization of their R&D and QC Lab working. This pharmaceuticals called upon us to get to modify our existing lab inventory software to their R&D and QC labs. It has gone through extensive 21CFR11 validation testing at R&D Lab and in commercial use over past three months with more than 100 licenses. Our team provided Developmental and Validation server testing support for this activity, before Production Go-Live.
As you may know, that it is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. iLabs contains all the required technical elements of a compliant system.
Responding to enormous pressures to shorten time-to-market and reduce overall R&D costs, pharmaceutical companies have been making significant investments in technology. Reliance on iLabs™ will provide you not only the digital audit trails, but also control on inventory. Through it many automated reports and alters, iLab provides your team with information in forms of inventory usage trend, scraps, new purchases required and ordered, upcoming expiries, availability, vendors and cost reports. It alerts the users and store keepers on the issue of material and product expiration and no stock-out scenario’s. These reports the provide a smooth in-time inventory availability while ensuring minimum wastage due to expiry. Based on usage trend, you can ensure availability without having to worry about excesses or running out of any materials. These translates into savings while adding velocity to your work.
As an enterprise software, iLabs can handle 20-2000 users concurrently. It supports full organizational hierarchy and configurable roles today, and in next release will provide fully configurable asset management process. Based on HTML 5.x, ext.js and .NET Technology, it leverages Window’s Business Server and MS SQL’s enterprise capabilities. Its REST APIs allows complete integration with any of your legacy applications. Being a browser based software, iLabs can be accessed by users with Windows, Linux, Apple or Android devices.
This software is user friendly and easy configurable features. For a free demo contact firstname.lastname@example.org or call +91-20-60708028.