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The FDA requires that software systems used for quality purposes in place of paper records must be validated for their intended use [Title 21 CFR Part 820.70 (i)].  This means that using configurable off the shelf (COTS) systems, companies must verify that the software is configured correctly to meet their business needs.  Even if you are intending to do a basic implementation you need to have documented evidence verifying that the system was correctly installed and configured.

Software Validation / Verification

Validation Plans, User and Functional Requirements Specifications, Risk Assessment Reports, Software Design Specifications, IQ/OQ Documentation, Test Protocols and Test Reports

FDA 21 CFR Part 11

Develop evaluation and remediation plans for guideline compliance, implement systems which use electronic signatures in all areas where this regulation applies not just the system piece

Work Instructions/SOP

Develop work instructions specific to customer use of software application, generation and revision of operation procedures for quality assurance purposes

Acquisition Quality Data Migration

Insure validation of data from purchased companies is properly merged with existing quality systems

Gap Analysis & Audit Remediation

Perform system and software gap analysis for fiscal decisions, work with QA and Regulatory Affairs to remedy audit findings 

Custom Documentation

Develop custom documents specific to customer business processes and IT procedures

Who We've Worked With

ERP

  • Q'apel Medical - NetSuite

  • Signifier Medical Technologies - NetSuite

  • Beyond Air Ireland Ltd - NetSuite

  • Pine Trees Health (Proof) - NetSuite

  • Shine Medical Technologies - NetSuite

  • Locus Biosciences, Inc. - NetSuite

  • HGI PYURE Technologies - NetSuite

  • Sonex Medical - NetSuite

  • Sanuwave Medical - NetSuite

  • Celularity - NetSuite

  • Chembio Diagnostics Systems - NetSuite

  • Mizuho America - Microsoft Great Plains

  • Shockwave Medical - QAD

  • Meditrina - NetSuite

  • Inari Medical - NetSuite

  • MeiraGTx - NetSuite

  • Vero Biotech - NetSuite

  • Biocare Medical - Microsoft Great Plains

  • Spectra Medical - NetSuite

  • Ivantis - NetSuite

  • Think Surgical, Inc. - Epicor

  • InCube Labs (Modulus) - QAD

  • Senseonics - NetSuite

  • Coghlin Companies (Columbia Tech, Cogmedix) - Epicor

  • Spirox - NetSuite

  • Tanner Pharma Group - NetSuite

  • Somahlution - NetSuite

  • Spinal Modulation, Inc. - QAD

  • NuTech - NetSuite

  • Minerva Surgical, Inc. - QAD

  • Elixir Medical, Inc. - QAD

  • CardioFocus, Inc. - Epicor

  • Zonare Medical Systems - Microsoft Great Plains

  • A.P. Pharma, Inc. - QAD

  • MyoScience - SAP BusinessOne

  • The Tech Group a West Pharmaceutical Company - QAD

  • Robert Bosch Healthcare and Telemedicine - NetSuite

  • Solta Medical - Netsuite

  • Conceptus - QAD

  • FoxHollow Technologies - QAD

  • Genentech - QAD

PLM/ Document Managment

  • TAE Beam Technologies - Arena

  • LifeScience Logistics - Compliance Quest

  • Spectra Medical - DocSTAR

  • Bigfoot Biomedical - Arena

  • Coghlin Companies (Columbia Tech, Cogmedix) - Omnify

  • RefleXion Medical - Arena

  • TransMedics - Omnify

  • Proteus Digital Health - EtQ

  • Earlens - Omnify

  • PowerVision - Omnify

  • Benvenue Medical - Omnify

  • LifeScience Logistics - MQ1

  • Autonomic Technologies - Omnify

  • Zonare Medical Systems - Omnify

  • Thoratec - Omnify

  • Convergent Dental - Omnify

  • SurgiCount Medical - TestTrack, Perforce, Salesforce.com

  • RefleXion Medical - TrackWise

  • MyoScience - Omnify

  • LNK International, Inc. - TrackWise

  • Alcon / LenSx Lasers - MQ1

  • Robert Bosch Healthcare and Telemedicine - RitePro

  • Arstasis - Custom eQMS

  • Conceptus - Master Control

  • Solta Medical - Omnify

MES/ WMS/ Other

  • Coghlin Companies (Columbia Tech, Cogmedix) - Aegis

  • LifeScience Logistics - Tecsys

  • Earlens - Solumina

  • Biocare Medical - Axon Ivy

  • Coghlin Companies (Columbia Tech, Cogmedix) - Solidworks

  • Proteus Digital Health - JIRA

  • RefleXion Medical - Adobe E-Sig

  • Revance - IT Management Policy and Procedures

  • Myriad Genetic Laboratories, Inc. - JIRA

  • Cerephex Corporation - Product Validation

  • Robert Bosch Healthcare and Telemedicine - JIRA

  • AngioScore Medical - Cutom Software

  • FoxHollow Technologies - Custom Clinical Databases