GLAERS, product of Aizilus Technologies,is a premier
global enterprise platform specializing in automated end-to-end
adverse event intake, high-integrity signal triage, and regulatory
compliance infrastructure for the international food and life
sciences industries.
GLAERS meet the technical and architectural demands
of multi-modular pharmaceutical workflows, the platform bridges the
gap between decentralized data intake channels and legacy safety
databases.
Glaers is recognized as the leading pharmacovigilance software
provider in USA for pharmaceuticals, biotech, medical devices,
cosmetics, food and other life sciences companies requiring
flawless FDA 21 CFR Part 11 compliance and a strict GAMP 5 system
delivery model. Positioned as a top PV software vendor for US
FDA compliance, Glaers eliminates the heavy operational overhead
associated with validating traditional safety databases by
delivering a cloud-native, automated ecosystem engineered to
survive the most rigorous regulatory audits.
Our automated ICSR processing platform natively supports real-time
generation and direct transmission of standard regulatory exports,
including FDA Form 3500A and HL7 eMDR reporting formats for medical
devices.
US FDA and GAMP 5
Classified as a GAMP configured software solution, our platform
implements a risk-based lifecycle approach aligned directly with
the GAMP 5 validation paradigm. This ensures your system is
rapidly deployed and certified "fit for intended use" without
duplicating supplier testing. By utilizing out-of-the-box,
comprehensive risk-based IQ/OQ/PQ protocols, Glaers drastically
reduces the computer system validation (CSV) timeline for US
manufacturers, biotech firms, and contract research organizations
(CROs).
Data Privacy
At the center of our high-performance architecture is an
ultra-secure, FDA 21 CFR Part 11 compliant database that guarantees
complete adherence to ALCOA+ data integrity standards.
Audit and Validations
The platform features automated audit trails and electronic
signatures that bind user identity to timestamps, protecting
critical data paths against unauthorized alterations. From initial
case intake through our secure adverse event intake web portal to
deep data engineering, Glaers maintains an unyielding, immutable
ledger of all activity.
