AMPLEXOR: The Integral Solution for Pharmaceutical Compliance

Pharma Tech Outlook: Pharma Tech Magazine

AMPLEXOR: The Integral Solution for Pharmaceutical Compliance

CIO VendorElvis Pacelat, VP-Life Sciences Solutions
The recent technology advancements have propelled pharmaceutical companies into a virtuous cycle of integrated solutions, as they migrated from traditional paper-based to digital systems. Traditionally, the companies implemented many complex custom systems that allowed them to meet various intricate business and regulatory requirements. As years progressed, the systems consumed higher maintenance costs and yielded poor results in response time and productivity, due to its inability to adapt to changes. Rising to this precise challenge and exigency for an integrated solution, Bertrange-based vendor, AMPLEXOR delivers the AMPLEXOR Life Sciences Suite—groundbreaking shared-data modeled software.

“Sharing the same data model and repository between modules enables single-point entry and reuse of data across modules, eliminating delays and disconnection in information propagation,” explains Elvis Pácelat, VP-Life Sciences Solutions, AMPLEXOR. The flagship product, AMPLEXOR Life Sciences Suite is a composite of several solutions like, ProductExpert, R&DExpert, ClinicalExpert, QualityExpert, and VigilanceExpert, to name a few. Covering the entire product lifecycle, these modules share the same data model and are built on top of a single platform, the AMPLEXOR Compliance Foundation.

The software can be implemented as a standalone module with optional third-party integrations and consolidated with other modules, as part of the integral solution. Keeping in line with the industry’s ongoing trends for the shift towards cloud, the software reduces the complexity and cost of hosting and management, enabling pharma institutions to conform to government regulations and audit-compliance. The software suite provides content and process management capabilities, including business intelligence insight that encompasses all critical data—from documents to records—across the product lifecycle, enforcing data standards, like ISO and IDMP.

AMPLEXOR’s portfolio has a prolific clientele that includes the top players in the pharma arena, Pácelat cites the case of a top 100 pharma company.

Leverage AMPLEXOR Life Sciences Suite to manage enterprise regulated content and processes as well as publishing. Achieve and maintain global regulatory compliance, with one authoritative source of truth, Integral by Design, Modular by Implementation

After assessing a battery of vendors and solutions, the pharmaceutical institution decided to go with the AMPLEXOR Life Sciences Suite, owing to its capability to fulfill the organization’s requirements, at a reasonable price on an acceptable scale of risk. “The system was deployed within estimated timelines and the fact that the customer chose AMPLEXOR over leading life sciences solutions made us proud,” extols Pácelat.

With a constant passion for innovating out-of-the-box solutions and a sharp focus on setting things right, Pácelat indicates the suite’s integral design as their biggest innovations. Denoting the insider’s perception of the software, Pácelat says, “AMPLEXOR is integral by design, but modular by implementation.” This design calls for a new generation of functionalities, like regulatory intelligence including region specific legal and regulatory standards and meta-tenancy, which removes the dependencies of location in processing the applications and data.

Marking a distinguished spot for itself among peer vendors, AMPLEXOR stays ahead by proactively making informed decisions and staying abreast of committee activity in a market where other solution providers wait on regulatory agencies for implementation guidance. “At AMPLEXOR, there is a consistent entrepreneurial spirit that has been recognized by customers as a unique differentiator,” Pácelat states.

With tabs on integral cloud solutions and meta-tenancy, the provider has high-hopes on structured authoring—which focuses on data-entry at an elementary level and then collates the information into documents— along the future roadmap. “With many historically failed prototypes of structured authoring, it is our intent to find ways where it can be successfully implemented,” affirms Pácelat.
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