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