Open site navigation

A Common Sense Approach To Regulatory Software Validation

At PGTS we want to be your validation resource, not your one time connection.

Over 25 years of experience in the industry

Experience with an extensive variety of software

A unique approach to software validation and faster testing times

Reliable methods that allow for growth

Featured Services

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:

Develop work instructions specific to customer use of software application

Custom Documents:

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

PLM/ Document Management

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

​​​

WMS/ MES/ Other Systems

Coghlin Companies (Columbia Tech, Cogmedix) - Aegis

 LifeScience Logistics - Tecsys

Earlens - Solumina

   Biocare Medical - Axon Ivy  Coghlin Companies (Columbia Tech, Cogmedix) - Solidwork   Proteus digital Health - JIRA

  RefleXion Medical - Adobe E-Sig

    Revance - IT Management Policy and Procedures

   Myriad Genetic Laboratories, Inc. - JIRA