An integral solution for the management of the quality control and assurance areas, I+D, and regulatory issues.
Integral solution for the management of the quality control and assurance areas, i+d, and regulatory issues.
Integrated quality management system
Reduction of recalls
Reduction of OOS
Reduction in calculation errors
Automated COAS
Circuit of electronic signatures
Best preparation for audits
Productivity growth
Modules and functions
LIMS
QMS
REGULATORY ISSUES*
PHARMACOVIGILANCE*
APR
CALCULATIONS GENERATOR
It eases calculations, which are audited and validated avoiding errors.
It allows to implement strategies according to the analysis procedure.
Management of calculation documentation.
Management of calibrations.
Integration with stability and routing testing.
VERIFARMA IoT
Integration with the laboratory suitable equipment.
Captures and records all the measurements made at time slots defined by the user.
Online indicators and alerts.
Monitoring and predictive analysis.
Management of results.
STABILITY
Management of Stability studies
Integral management of deviations and results out of specification.
Scheduling of testing intervals.
Planning of weather conditions and tests.
Pull out alarm.
Statistical data.
Comparison of historical data.
INVENTORY MANAGER
It allows the management of all the supplies existing in the laboratory.
Generation of stock reports, control of stock, purchase requirements.
Management of stability samples.
Expiration dates reminder.
Minimum Stock for reagents.
ROUTINE TESTS
Management of quality control tests.
Certificates of analysis (COA).
Fast access to historical results.
Management of OOS (results out of specification).
Planning of tests.
*Consult its application for each market.
Management of the SGC (claims, deviations, CAPAs, exchange controls and audits).
Document management (SOPS).
Risk management.
Program administration.
Recall
KPI’s
Training Administration
Administration of existing records. Renewals and Registrations.
Generation of Special Reports: (Chemical Precursors, Psychotropics, Alcohols, etc).
File monitoring.
Edition of Dossiers for Records.
Compilation of batch and unit formulas, studies, validations, among others.
Administration of adverse effect reports.
Generation of periodic reports or IPAS.
Risk management plans (PGR).
Communication of adverse effects.
It contains all the trials of each batch of all the drugs studied.
It records the deviations of the Routine Analysis and Stability Reports modules.
Issuance of annual report of each product.
*Consult your application for each market.
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