The cloud solution that allows ensuring the quality of its processes

An integral solution for the management of the quality assurance and control areas, I+D, and regulatory issues.

Benefits

  • Automated processes, suppressing manual schedules
  • Integrated quality management system
  • Decrease of Recalls
  • Decrease of OOS
  • Decrease of miscalculations
  • Automatic COAs
  • Electronic signatures circuit
  • Best preparation for audits
  • Increase of Productivity

CALCULATION

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CALCULATIONS GENERATOR

  • Calculations audited and validated avoiding errors.
  • It allows to carry out strategies according to the analysis procedure.
  • Calculations documentation management.

STABILITY

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STABILITY

  • Stability Studies Management.
  • Comprehensive management of deviations and out-of-specifications results (OOS).
  • Scheduling of analysis intervals.

INVENTORY

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INVENTORY

  • Allows the administration of all the existing supplies in the laboratory.
  • Stock reports generation, stock control, purchase requirements.

ROUTINE ANALYSIS

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ROUTINE ANALYSISA

  • Quality Control Analysis Management.
  • Issuance of analysis certificates.
  • Fast access to historical data.
  • OOS Management.

QA MANAGER

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QA MANAGER

  • Comprehensive Quality Assurance Management.
  • Calibration and maintenance programs.
  • Planned and Unplanned deviations.

PHARMACO VIGILANCE

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PHARMACOVIGILANCE

  • Adverse Effects Reports Management.
  • Periodic Reports or IPAS.
  • Risk Management Plans.

REGULATORY AFFAIRS

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REGULATORY AFFAIRS

  • Administration of Existing Registries. Renewals and inscriptions.
  • Special Reports.
  • Files tracking.

VALIDATION OF ANALYTICAL METHOD

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VALIDATION OF ANALYTICAL METHOD

  • Validation Protocol Management, data processing, evaluation of results and generation of final report. .

ANUAL PRODUCT REPORT

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ANUAL PRODUCT REPORT

  • Compiles tests of each batch studied.
  • Registers the deviations of Routine Analysis and Stability Reports modules.
  • Annual Report for each product.

VERIFARMA IoT

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VERIFARMA IoT

  • Integration with laboratory suitable equipment
  • Online indicators and alerts
  • Predictive monitoring and analysis
  • Results management

Verifarma LIMS is a validatable solution that makes-up the quality processes of a pharmaceutical laboratory”

Quality and standards

  • ISO 9001 Certification on Quality Management, and ISO 27001 Certification on Information Security Management.

  • CFR 21, part 11 FDA Compliance.
  • GAMP5 Validation.

  • IQ, OQ and PQ protocols development and implementation.

  • Implementation of GS1 standards since 2008.

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