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Quality Systems Management
PharmaSys provide quality
systems development and ongoing resources for
quality management to pharmaceutical, biotech,
medical device, pre-clinical and clinical
organizations as well as suppliers to the
industry.
...Tested
...Trusted... PharmaSys.
Since 1998, PharmaSys has completed over 600
engagements with no 483 or warning letter
observations. Our record speaks for itself!
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Sample Engagements
Developed Computer Validation
Program for $2 Billion Medical Device
Manufacturer
Developed Medical Device Quality
System Regulation/cGMP program (21
CFR 820 & 211) for startup
combinational product manufacturer
Developed Medical Device Quality
System Regulation (21 CFR 820) for
startup medical device manufacturer
Developed
Supplier Management Program for
leading software supplier for
clinical trial industry
Reengineered software validation
processes for SaaS systems for
leading software supplier for
clinical trial industry
Developed and administered quality
system for startup CRO
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