AMPLEXOR Releases VigilanceExpertTM 5.0 to Harmonize and Standardize Processes in Pharmacovigilance Information Management

April 4, 2019 Off By BusinessWire

New module available as a standalone solution or fully integral with
AMPLEXOR’s Life Sciences Suite

BROOMFIELD, Colo.–(BUSINESS WIRE)–The Life Sciences division of AMPLEXOR, today announced release of
AMPLEXOR VigilanceExpert^TM 5.0, the latest update of its Life
Sciences Suite of solutions that helps Life Sciences companies overcome
challenges in Regulatory Affairs (RA), Research and Development (R&D),
Quality Assurance/Quality Control (QA/QC), and Pharmacovigilance (PV).

VigilanceExpert 5.0 comes as the result of AMPLEXOR’s own commitment to
R&D and consolidates the requirements for a pharmacovigilance safety
database, reporting and document management into one overall holistic
process.

The AMPLEXOR Life Sciences Suite enables Life Sciences organizations to
benefit from a single software product to address main industry
challenges, especially around compliance and efficiency. With some
companies still using isolated systems, VigilanceExpert as
part of the integral Life Sciences Suite further reinforces its position
as an essential solution, which provides one authoritative source of
truth to users.

“In an increasingly global marketplace, Life Sciences organizations are
facing a growing number of compliance challenges as they expand into
different markets across the world,” said Renato Rjavec, Director of
Product Management, AMPLEXOR Life Sciences. “We understand these
challenges and based on discussions with our customers, we took the
opportunity of the new ISO ICSR / ICH E2B R (3) electronic reporting
format requirements to launch the completely redesigned AMPLEXOR
VigilanceExpert 5.0, which standardizes the processes around
pharmacovigilance information management. Used in conjunction with our
Life Sciences Suite and based on the common master data layer, it forms
an extremely powerful and authoritative solution.”

Pharmacovigilance – the collecting, recording, assessment and reporting
of the adverse effects of drugs – must be stored in a company’s database
and reported to authorities within strictly defined timelines in a
compliant electronic format. This process is fully supported in
VigilanceExpert 5.0 and is flexible for adaptation to customer specifics
through simple reconfiguration. VigilanceExpert 5.0 includes embedded
gateway functionality for direct electronic submission of safety cases
to EMA, FDA and other health authorities as well as periodical reporting
capabilities. Within the same solution, Pharmacovigilance System Master
Files as well as other pharmacovigilance documentation can be managed
with full scale document management capabilities.

As an on premise or cloud-based solution, VigilanceExpert 5.0 offers
complete flexibility in terms of location and accessibility, and when
deployed as part of the overall Life Sciences Suite it will increase
efficiencies through data consistency across modules.

“We have always put our customers’ requirements to the fore when
developing new modules and solutions and VigilanceExpert 5.0 is a
perfect example of this,” said Elvis Pacelat, Executive Vice President,
AMPLEXOR Life Sciences. “VigilanceExpert 5.0 offers powerful flexibility
for its users and is a significant leap forward for any organization
looking to improve pharmacovigilance – as such it plays a very important
role in our holistic Life Sciences Suite.”

About AMPLEXOR Life Sciences

AMPLEXOR Life Sciences assists
organizations developing pharmaceutical drugs, medical devices, and
biotechnology with launching products and breaking into new markets
quickly. Our solutions and services expedite the creation and delivery
of consistent, compliant, high-quality and global content – both
physical and digital. Service offerings include technology consultancy,
implementation, and management services as well as technical writing,
medical translation, and linguistic validation.

AMPLEXOR employs 1,800 people in 23 countries across four continents. It
boasts a rich 25+ year history of serving pharmaceutical producers,
medical device manufacturers, and biotechnology companies.

For more information, go to www.amplexor.com.