BROOMFIELD, Colo.--(BUSINESS WIRE)--The Life Sciences division of AMPLEXOR, today announced release of AMPLEXOR VigilanceExpertTM 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.