Audit Utopia is a real-time inspection management system for tracking and managing inspections in order to streamline team efforts and improve response time for inspection requests.

1. PSC Biotech™
Audit Utopia

2. For over two decades we have
organically grown our
consultancy to a worldwide
business with operations in North
America, Latin America, Europe,
Asia, and the Middle East.
This global footprint helps us
service our large, multinational
clients in ways that smaller,
regional competitors cannot. This
also affords us a global
perspective on where the life
sciences market is going and how
to most effectively position our
company to meet both current
and future trends.
Why PSC Biotech™?
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

3. We’re proud to work with
some of the top life science
companies around the world.
From medical device to
naturopathic, we have the
expertise to fit your needs.
We’re also proud to have
worked with companies from
their infancy and through
their growth, supporting
them when and where they
need us.
Our Client Base
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

4. For over two decades we have
organically grown our
consultancy to a worldwide
business with operations in North
America, Latin America, Europe,
Asia, and the Middle East.
This global footprint helps us
service our large, multinational
clients in ways that smaller,
regional competitors cannot. This
also affords us a global
perspective on where the life
sciences market is going and how
to most effectively position our
company to meet both current
and future trends.
Worldwide Audits: Global Footprint With Regional Expertise
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

5. PSC Biotech™ has extensive
experience in auditing GxP
companies – from assisting
companies with an upcoming
pre-approval inspection to
third-party suppliers and
testing facilities.
Our staff of seasoned
professional auditors has
experience with the FDA, ISO,
and international regulatory
agencies.
Audited Companies
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

6. Audit Services: Client Compliance Support
• 483 / Warning Letter
remediation
• QA Review (GLP, GMP,
GCP)
• Risk Assessments
• EM Program
Analysis/Creation
• Microbiology Laboratory
Consulting
• Supply Chain Evaluation
• Specialized Support
Remediation Support
• On-Site Auditing
• Finish Fill CMO’s
• API Manufacturers
• Excipient
Manufacturers
• General Chemical
• Secondary Packaging
• Primary Packaging
• Paper Auditing
(Questionnaire Management)
• Supplier Qualification
• Turn Key Supplier
Management Program
Supplier/Vendor
Management• Mock Pre-Approval
Inspections (PAI) and mock
FDA audits
• Mock Notified Body
Inspections
• Quality system & corporate
SOP gap analysis
• Data Integrity Audit
• Mock recalls
• Formal risk assessments & risk
mitigation strategies
Internal Auditing
Experts in Regulations:
• GMP
• GLP
• FDA 210/211
• FDA 820
• FDA Part 11
• FDA 225
• 10 CFR 50 & Appendix B
• FSMA
• ICH Q7
• ICH Q10
• EU Guidance
• GAMP
• ISO 9001
• ISO 13485
• ISO14001
• ISO172025
• ISO 45001
• IATF 16949
• AS9100
• NQA-1
1 2 3
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

7. Audit Services: Client Compliance Support Cont.
• Supplier questionnaire
submitting
• Grading
• Risk Assessment
• Supply Chain
Support
• Supplier Training
• Full Turn Key Plans
Available
Full Service Management
• Industry Experts:
• PDA
• ASQ
• RAPs
• ISPE
• Internal Training
• Continuous Training
• Client Required Training
for Dedicated Client
Programs - Available
Auditor Training
• Years of experience
• Auditor Selection based on
all Audit Criteria
• Dedicated Auditors are
available
• Specialized Auditors
Auditor Selection
Experts in Regulations:
• GMP
• GLP
• FDA 210/211
• FDA 820
• FDA Part 11
• FDA 225
• 10 CFR 50 & Appendix B
• FSMA
• ICH Q7
• ICH Q10
• EU Guidance
• GAMP
• ISO 9001
• ISO 13485
• ISO 14001
• ISO 172025
• ISO 45001
• IATF 16949
• AS9100
• NQA-1
4 5 6
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768

8. Audit Services: Audit Process
biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
Audit Reputation
• Trusted partners
• Follow up on findings
• Global Experts
• Speed
• Repeat Customer
1
2 Auditor selection
Made through website or
sales
Audit report and
continued support
Audit performed
3
4
Request
Selection
Execution
Completion
PSC proposal sent will outline:
• Type of Audit to be performed
• Location
• Auditors Qualification/Selection
• Length of Audit
• Special Request needs

9. Audit Management Software
AUDITUTOPIA
AuditUtopia™ is a realtime inspection management system
for tracking and managing inspections, trusted by life science
companies worldwide. Many organizations choose AuditUtopia™
as the center of their inspection team to seamlessly streamline
group efforts to improve response time for inspection requests.
AuditUtopia Benefits:
• Accessible anywhere
• 100% request tracking
• Real-time updates
• Report generation for requests
• Metrics & charts generation
• Complete auditor archive
• Incomplete inspection data capture
• Insecure communication
• “Where is the data?”
• “Where is it now?”
• Lost and incomplete request response
• Slow response time
AuditUtopia Prevents:
Automated
Reports
Runners
Pro-
Active
Printing
Doc
Shredding
Workflows
End of
Day
Meetings
Travel
FedEx
Raw
Person
hoursScribe