FDC, a Forerunner in Manufacturing of Oral Rehydration Salts and Ophthalmics, Chooses ValGenesis VLMS to Digitize Corporate Validation Process
Paperless validation to expedite manufacture and delivery of APIs and Finished Dosage Forms for global use
SAN FRANCISCO, March 29, 2019 /PRNewswire/ -- ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced that FDC has chosen ValGenesis's 100% paperless Validation Lifecycle Management System (VLMS) to digitize and standardize its validation lifecycle process across the organization.
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 set up 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 in India and exports many of them 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.
Realizing that traditional, manual, paper-based validation processes were proving both costly and inefficient, FDC decided it was time to consider a paperless solution. The company conducted a detailed evaluation of multiple solutions and selected ValGenesis Enterprise VLMS—an electronic, paperless solution that well meets the company's validation lifecycle needs. With ValGenesis Enterprise VLMS, FDC will significantly reduce validation cycle time, gain a higher standard of data integrity, improve regulatory compliance, and gain a holistic view of real-time validation status across its regulated systems, thereby improving the quality and speed of the entire process.
"We are happy that our search for a 100% paperless validation solution has finally ended," says Dr. Rupesh Kelaskar, Head of Corporate Quality Control. "It is time to make the move to paperless validation through a cloud-based electronic system such as ValGenesis VLMS, which enables rigorous compliance, improves process consistency, provides standardization and significantly reduces validation cycle time."
He further added, "We also expect the ValGenesis VLMS software solution to help us implement and enforce the validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents. ValGenesis's dedicated team helped us implement the system in four weeks to meet the implementation target date. We look forward to expanding our partnership with ValGenesis as they continue helping life sciences companies the world over eliminate the use of paper and remove the inefficiencies that plague today's life science validation processes."
"FDC, a leading life science company based in India, has selected our ValGenesis VLMS, which makes validation processes and activities seamless and transparent, thereby eliminating the need for time-consuming, costly and human intensive processes," says Narayan Raj, Sr. Vice President, Global Sales & Operations, ValGenesis Inc. "ValGenesis VLMS is a best-in-class software solution that offers all the benefits of an electronic system with necessary controls that adhere to global compliance needs, which is appealing to more and more global life science companies, such as FDC. We are excited as they continue to confirm the depth and width of the functionality our solution offers."
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 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 UAE, 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 www.fdcindia.com
Further information:
Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026
[email protected]
Dr. Rupesh Kelaskar, FDC Ltd., +91-22-2673 9100, Ex.385
[email protected]
SOURCE ValGenesis
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