We provide Software Products and Consulting Services related to Quality and Regulatory compliance to our customers in the Medical Device, Diagnostics, and Pharmaceutical industries.

Our Products Our Services

InfoMed

Complaint Handling and Adverse Event Reporting Software with full eMDR Support

Audits

Quality System audits and assessment: GMP, QSR, Part 11, MDD

InfoCAPA

CAPA (Corrective and Preventive Action) and Nonconformance Software

Validation

Software development life cycle, software validation, IQ/OQ/PQ

InfoAudit

Internal and Supplier Audit Software

Risk Analysis

Product, process, and software risk analysis (FTA and FMEA)

InfoTrain

Employee Training Software

Training

Quality systems, validation, risk analysis, design controls

InfoSQA

Software Quality Assurance

Implementation

Quality systems, quality manual, SOPs

InfoPV

Process Validation and Test Method Validation Software -- Now Available!

Software Services

510(k)s, audits, Part 11 compliance, risk analysis, validation, QA training

Full web application versions of InfoAudit and InfoPV are now ready to order! Click here for more information on InfoPV.

We now have an office in Costa Rica to serve Latin America! Click here for Makromed Costa Rica.