Infosys, a global leader in consulting, technology and
next-generation services, today announced a new partnership with paperless
validation company ValGenesis that will bring even stronger compliance and
quality management for its customers in the healthcare and life sciences
sectors. Under the partnership, Infosys will integrate ValGenesis’ Validation
Lifecycle Management System (VLMS) within its suite of services for the
pharmaceutical and biotech industry, which will be delivered in a rapidly deployable,
highly secure cloud environment.
ValGenesis is a leading paperless validation lifecycle management
solution in the life sciences industry that allows customers to automate the
validation process fully, eliminate inefficiencies found in paper-based manual
processes, while also reducing costs and validation cycle times. The
ValGenesis Validation Lifecycle Management System (VLMS) efficiently manages
all types of validation activities such as equipment, computer systems,
cleaning, analytical methods, and process validation. The system delivers
technology solutions that are fully configurable and rapidly deployable onsite
or by way of a secured cloud environment.
Validation systems are still almost entirely manual, paper-based
process, resulting in significant inefficiencies, higher costs and more
significant opportunity for errors to creep in. They can also result in delays
to life-saving medicines and procedures to patients. ValGenesis’ VLMS includes
a regulatory framework allowing validation requirements to be specified in
advance. Risk Management, a key component of VLMS, is integrated and flexible,
giving companies the ability to leverage standard risk tools to best suit their
needs. Reusability is inherent and available at test and requirement levels,
significantly improving efficiency via pre-approvals. Consistency is also
driven by standardization which improves a company’s compliance posture.
Infosys’ Life Sciences Practice works with 50+ leading
pharmaceutical and medical devices companies, providing premium regulatory,
quality and compliance services. Leveraging its extensive capabilities and
experience in the life sciences space, Infosys will deploy the ValGenesis
Validation Lifecycle Management System (VLMS) to its customers as a single “paperless”
system that manages every activity in the entire validation lifecycle. Through
this partnership, Infosys will help biopharma and medical devices customers
transform to next generation of automation driven quality and compliance
services which will help organizations generate significant efficiencies and
allow them to focus on their core business.
Sangita Singh, Executive Vice President and Head, Healthcare &
Lifesciences, Infosys,said,
“Healthcare is potentially the world’s most stringently-regulated industry. The
huge volumes of highly-sensitive information that biotech and life sciences
firms generate is subject to incredibly strict standards – for example,
recording the outcomes from clinical trials. The digitization of the industry
to ensure better data and document accuracy is incredibly important for many
ethical, legal and business reasons, with auditors and regulators demanding
that data regarding equipment, computer systems, processes, and outcomes be
properly recorded and validated. ValGenesis is pioneering paperless validation,
and our new partnership will bring significant savings and much better
compliance to our customers.”
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