Fully meets OECD GLP and FDA 21 CFR Part 58 regulations for study protocol controls and data security.
Construct visual study timelines, define dose intervals, log observation points, and manage study milestones.
Document protocol deviations immediately, log impact assessments, and obtain QA approval signatures.
Maintain a full history of study plan amendments with automatic version control and revision comparisons.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Design study protocols including study goals, guidelines, species selection, and testing methodologies. Manage multiple study templates.
Allocate animals to study groups, manage randomization matrices, and track cage allocations in accordance with study parameters.
Configure dosing concentrations, specify test item formulas, set dosing intervals, and log administrator IDs.
Technicians enter daily observations, body weights, feed consumption metrics, and clinical signs directly into mobile interfaces.
Log deviations immediately (such as missed doses or schedule drifts), record impact evaluations, and secure QA sign-off.
Draft, review, and approve study plan amendments. The system versions documents automatically, preserving audit histories.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Draft study metadata, define study objectives, select animal models, and allocate study directors.
Specify dose groups, set study timelines, define observation criteria, and input test item parameters.
Allocate subjects to target study groups using randomization tables, printing barcoded cage cards.
Submit protocol for review. Study directors, QA supervisors, and sponsors approve using electronic signatures.
Technicians execute dosing, collect daily observation logs, and enter research measurements directly.
Document amendments and log protocol deviations with QA evaluation records and sign-offs.
Aggregate dosing logs, charts, and deviations to generate the final study report, archiving the study record.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Preclinical studies are governed by protocol design SOPs, linking technicians directly to active procedural templates.
Prevent unqualified personnel from dosing or logging observations. LMS qualification is verified before check-ins.
Critical study deviations can trigger quality deviations in the QMS to investigate systemic facility failures.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
Maintain data integrity and meet FDA 21 CFR Part 58 regulations for preclinical study compliance.
Automated schedule alerts and dose checkers guide technicians to complete tasks on time.
Auto-aggregate study logs, observations, dose histories, and deviations to generate draft study reports.
Ensure raw research data is locked immediately at the point of creation, preventing post-hoc edits.
Fully optimized to support critical environments with strict GxP, ISO, or GLP compliance requirements.
We combine cutting-edge software design with rigorous pharmaceutical validation methodologies.
Learn MoreDeveloped following strict GAMP 5 software guidelines to simplify compliance validations.
Enforce electronic signatures for protocol approvals, dose validations, and study report closures.
All protocol drafts, amendments, observation logs, and audit logs are preserved in a secure system.
Control study design, raw data entry, and approval privileges using dynamic user roles.