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We provide Software Products
and Consulting Services related to Quality
and Regulatory compliance to our customers
in the Medical Device, Diagnostics, and Pharmaceutical industries.
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Our Products
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Our Services
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InfoMed
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Complaint Handling and
Adverse Event Reporting Software with full eMDR
Support
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Audits
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Quality System audits and assessment: GMP, QSR, Part 11,
MDD
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InfoCAPA
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CAPA (Corrective and
Preventive Action) and Nonconformance Software
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Validation
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Software
development life cycle, software validation, IQ/OQ/PQ
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InfoAudit
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Internal and Supplier
Audit Software
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Risk
Analysis
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Product,
process, and software risk analysis (FTA and FMEA)
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InfoTrain
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Employee Training Software
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Training
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Quality
systems, validation, risk analysis, design controls
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InfoSQA
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Software Quality Assurance / Software Development and Validation
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Implementation
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Quality
systems, quality manual, SOPs
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InfoPV
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Process Validation and Test Method
Validation Software -- Now Available!
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Software
Services
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510(k)s,
audits, Part 11 compliance, risk analysis, validation, QA training
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Full web application versions of InfoAudit
and InfoPV are now ready to order! Click here for more information on InfoPV.
Latin America offices in Costa Rica since 2011.
MyFDA Academy e-Learning Center is now online!
MyFDA Academy is an e-learning center where
people involved in the medical device, pharmaceutical, and biotech
industries can take online training courses on a variety of topics
relevant to the Quality Management System and/or Regulatory Compliance
aspects of these industries. Check it out here.
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