Validation Services

Validation Services - Computer Systems

Nivasoft, Inc provides total validation services to ensure that your computer systems are compliant with FDA, GxP, 21 CFR Part 11, Other Governmental regulations and industry standards.

Our Services include:

  • Validation Strategy and Implementation.
  • Computer Systems Validation
    • Network and Infrastructure Qualification.
    • Document Management Systems.
    • Clinical Trials Systems.
    • Drug Safety Systems.
    • Quality Management Software (QMS).
    • EDC Systems.
    • CAPA Systems.
    • Prospective and Retrospective Validation.
  • Re-Validation
  • Validation Staffing
  • Validation Documentation including VMP, IQ/OQ/PQ, Trace Matrix, Summary Reports, Standard
  • GAP Analysis and Risk Assessments.
  • Vendor Audits.
  • Quality Review Services.
  • Technical Writing.
  • CSV Training

Validation Services - Equipment and Lab Systems

Nivasoft, Inc provides complete Laboratory and Equipment Validation Services to ensure that your lab systems and equipment meet GLP, GMP and GCP standards along with 21 CFR Part 11 and other industry standards and regulations.

Our services include:

  • Development and Implementation of Master Validation Plans.
  • Develop and Execute IQ/OQ/PQ for Laboratory Systems and Equipment.
  • Develop Standard Operating Procedures (SOP's) for Administration and Maintenance.
  • Conduct GAP Analysis and Risk Assessments and Develop Remediation Plans.
  • Evaluation of Current Compliance States.
  • Quality Review of Documentation, Protocols and SOP's
  • Lab Sytems: HPLC's, UV Vis, Densitometer, Polarimeter, LIMS, Bioanalytical LIMS,
  • Titrators.Projects: Waters Empower, Agilent Chemstation, Brinkmann Workcell / TiamoWorkstation, ImageQuant, Analyst and more.

Please click here to download our Validation Services brochure.