Verifarma LIMS 2017-12-06T15:37:56+00:00

Characteristics

  • Manages all the Programs with responsibility for Quality, Development, Manufacturing and Regulatory Affairs.
  • Flexible and modular system that adapts to laboratory needs.
  • Historical record of performed analyzes.
  • Registration, validation and approval of results by user profiles.
  • Security in transactions, logs and tracking of events by user.
  • Friendly, accessible and user-friendly interface.
  • System accessible from any computer connected to the internet.
  • Personalized support and assistance.

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.

REGULATORY AFFAIRS

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REGULATORY AFFAIRS

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

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.

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. .

REGISTRY DOSSIER

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REGISTRY DOSSIER

  • Dossiers edition for Product Registration.
  • Compilation of batch formulas, unit formulas, studies, validations, among others.

PHARMACO VIGILANCE

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PHARMACOVIGILANCE

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

QUALITY & 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.

GOT QUESTIONS?

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