The Navitas pharmaREADY Validation Consulting team can provide experienced QA Specialists performing Quality Assurance services tailored to your needs at low cost in a time-efficient manner. The pharmaREADY Validation Consulting team has over 20 years of experience, a proven success rate, and many satisfied global customers.

The pharmaREADY Validation Consulting team can provide the following validation services.

Let us help you meet regulatory requirements and prepare you for audits! and inspections!

Resolve Quality issues quickly with the help of the pharmaREADY Validation team
"Your Solution for Compliance"

"Their knowledge and experience in both regulatory matters and information technology has made them an ideal business partner for us."
Dana Toops, Executive Director, Regulatory Affairs and R&D, Banner Pharmacaps.

 

pharmaREADY Software Validation Package

  • IQ/OQ Package:
  • PQ – Performance Testing Available: Performance tests will be customized to verify successful performance based on customer needs and intended functions.

Software Validation Documentation

  • Validation Services for any Application (COTS or In-House)
    • Including Functional Requirements, Validation Test Plan, Test Scripts, and Validation Summary Report
    • Including drafting Operational SOPs for the Software
  • Types of Software
    • LIMS – Laboratory Information Management System Software
    • Applications used in Laboratory Processes for clinical and non-clinical study samples
    • Laboratory Analysis Software (Genotyping, MassArray, Sequencing, Gene Expression, Sequenom and Affymetrix Platforms)

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Equipment Validation Documentation

  • IQ/OQ/PQ for any Instrument
    • Including drafting Operational and Calibration/Preventative Maintenance SOPs for the Equipment
  • Types of Equipment
    • SpectraMax Spectrophotometers with Softmax Pro Software
    • SpectraMax Fluorometers with Softmax Pro Software
    • Nanodrop Robots
    • Multiprobe Robots and other Liquid Handling Robots
    • Tecan Robots
    • PlateMates
    • Biomek Robots
    • AlphaImagers for gel electrophoresis
    • LightCyclers
    • Hybridization Ovens
    • Chip Scanners
    • Refrigerator/Freezer Temperature Monitoring Systems
    • Barcode Scanners
    • BioAnalyzers
    • Micromaster Microscopes
    • QIAGEN Biorobot Universal System

  • Qualification of any Operational Software that runs the instrument (Operational software is inherent to the instrument and will be considered validated as part of the instrument qualification. For the purposes of equipment validation, verification of instrument performance is indicative of acceptable software performance.)

  • Equipment with On-Board Software Applications
    • Nanodispenser and other Chip Spotting Equipment
    • QIAcube

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Test Method Validation Documentation

  • Validation Plan
  • Test Cases
  • Validation Summary
  • Laboratory Assays
    • Genotyping Assays
      • Method Validation documentation can be a big burden to Biotech and Pharma Companies because it is generally time-consuming.  We can offer these services for assays they need to validate for regulated studies which will free up their time to perform the testing and continue with lab work.

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QA Audit Preparation and Response

  • Assist QA Deptartment with preparation for an audit conducted by clientele or an inspection being conducted by a regulatory body
    • Document and Data Review
    • Conduct internal process audits to detect and correct non-compliance
    • SOP writing
  • Assist QA and operations staff in resolving Quality issues and develop action plans to correct deficiencies
    • Assist QA with Audit Responses
    • Assist with Part 11 Remediation and Compliance
    • Qualify Excel Spreadsheets:  Microsoft Excel is not Part 11 compliant. However, there are security and protective measures which can be implemented to decrease risk.
  • Conduct Vendor Qualification and Maintenance Audits
02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures ingredients for global...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the...

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules...

16
Oct2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ...