Client Background

Alembic Pharmaceuticals Ltd. (APL) is an Indian multinational pharmaceutical company that is involved in the manufacture of pharmaceutical products, pharmaceutical substances, and intermediates. APL is also on pace to be a market leader in the macrolides segment of anti-infective drugs in India. Alembic has state-of-the-art R&D centers which collectively staff more than 500 scientists working on active pharmaceutical ingredients, oral solid dosage formulas, transdermal solutions, injectable substances, etc.

Alembic Research Centre is focused on novel chemistry, including new polymorphs, salts, and other processes eligible for a possible first-to-file opportunity. The fully-integrated R&D is made possible by AR&D, IP, RA, QA, technology transfer teams, and USFDA inspected pilot plants

Client Business Challenges or Project Requests

  • Client wanted to keep track of each document printed in office premises
  • Software must be 21 CFR Part 11 compliant, as APL is subject to regular FDA and ANVISA audits
  • There are many confidential documents that client wanted to control

KitelyTech Solutions

  • We are running this project using agile methodology
  • System name is DPCM (Document Control Printing Management System)
  • We worked to understand all client’s requirements  before beginning system design
  • System generates a unique number when any document is printed. System also keeps track of each document’s details, including: who requested document, at what time document was printed, who printed document, etc
  • For sensitive document printing, manager with security clearance is required to approve before person can print
  • We studied 21 CFR Part 11 compliance and developed 21 CFR part 11 compliant solution
  • Our software has passed FDA and ANVISA audits

CLIENT:  Alembic

TECHNOLOGY:  Asp.net, SQL Server

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