San Francisco, March 10, 2020

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management solutions, today announced that the digitized Computer System Validation process went live at FDC ARDL (Analytical Research Development Limited), driven by ValGenesis’s cloud-based Validation Lifecycle Management System (VLMS). FDC had chosen to partner with ValGenesis to digitize and standardize the validation lifecycle process across its organization. Since then, ValGenesis has been facilitating the enforcement of the organization’s validation standards and procedures as per their validation master plans, SOPs and policy documents.

With the ValGenesis VLMS going live at FDC ARDL for Computer System Validation, a rollout is also being planned shortly at Waluj, it’s Aurangabad Plant. ValGenesis VLMS is a cloud-based multisite system that allows FDC ARDL the flexibility to define validation processes independent to each of its sites. That said, the VLMS can also enforce validation processes throughout an organization through global templates and validation procedures, regardless of the number of sites. FDC plans to use VLMS for multiple projects, and to also digitize their Analytical Method Validation process.

FDC is a pioneer in the manufacture of specialized formulations, and the world’s leading manufacturer of ORS (Oral Rehydration Salts) since 1972. FDC has globally approved, multilocation manufacturing facilities across India to develop cost-effective, environmentally friendly, high-quality Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms that meet stringent ICH standards. Having filed over 150 local and international patent applications to date, FDC offers more than 300 of its products to over 50 countries across the globe. The company was the first in South East Asia to offer ophthalmic formulations using Blow-Fill-Seal (BFS) technology and has a marked presence in numerous therapeutic segments such as anti-infectives, gastrointestinal, ophthalmological, vitamins/minerals/dietary supplements, cardiac, anti-diabetes, respiratory, gynecology, dermatology, analgesics and others.

“FDC is technologically focused and we wanted to develop and implement a lean, compliance-friendly, cost efficient electronic validation process across our organization, which is what the ValGenesis VLMS is doing for us. It is that one solution that is so easy to implement and use, to address all validation challenges in our industry,” says Dr. Rupesh Kelaskar, Head of Corporate Quality Control. “The support received from ValGenesis’s senior management and team throughout the implementation was excellent and a key factor for this project meeting its aggressive schedule. Best practices in business readiness, and robust change management and communication during implementation helped us get onboard quickly and without difficulty. We look forward to a successful rollout at our Aurangabad Plant and across our other sites.”

Further information:

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026

althea.dsylva@valgenesis.com

Dr. Rupesh Kelaskar, FDC Ltd., +91-22-2673 9100, Ex.385

rupesh.kelaskar@fdcindia.com

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

For more information, visit https://www.valgenesis.com

About FDC Ltd

FDC is a leading Indian pharmaceutical company with a dominant position in manufacturing and marketing of Oral Rehydration Salts (ORS) and Ophthalmics. FDC has set-up globally approved, multi-location manufacturing facilities for Active Pharmaceuticals Ingredients (APIs) as well as Finished Dosage Forms. It has accreditations from the US-FDA, UK-MHRA, MCC-RSA, and the PICs, to cite a few. These facilities are located at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh. FDC markets more than 300 products in India and exports many of these to over 50 countries. FDC strives to explore, innovate and integrate solutions with modern technology, empowering talent and expanding healthcare horizons for a better quality of life to millions globally.

For more information, visit https://www.fdcindia.com

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