PharmTech QMS presentation

Quality & Life Cycle Management

Core Services

ROI

Trac

eabi

lity

Syste

ms

Technology

Integration

Quality Management

Systems

What We Do

“PharmTech turns a cost into an investment.”

About Us

• Established in 1995• Emphasis on FDA compliance and regulated industries

Pharmaceutical, Medical Device and Biotech• Headquartered in Libertyville, Illinois• Employee Owned ESOP

Our People• Management/PMs average 10 years experience• Associates average 6 years experience• Permanent staff is comprised of • ASQ Certified Quality Auditors• Certified Supply Chain Professionals (CSCP)• Quality Engineers and Managers• IT personnel• 4-year technical degreed professionals

Our Clients

• Primarily Fortune 100 clients• 100,000 + hrs compliance services in 2008-2010• >75% repeat business• Approximately 50% projects > 5,000 hrs• Current projects in California, Georgia, Illinois & Texas

Partnering Benefits

LeadershipSubject Matter ExpertsLed remediation of CAPA initiativesFDA AuditsThird Party Audits

Experience16 Years in Pharmaceutical Manufacturing as a Validation ProviderCreated and Implemented Audit Programs

(Policy, Master Schedule, Execution and Resolution)Nationwide access to resources

Achieve Full Regulatory Compliance

FDA 483 and Warning Letter Action Plans and Remediation

Corrective and Preventative Action (CAPA) Systems

Methods & Process Validation

Auditing and Gap Analysis (GXP, ISO, QSIT)

Supplier Assessment, Management & Improvement

Clinical Operations

CFR parts 11, 210, 211, 820 and ISO 13485 and ISO 14971

System Expertise• cGMP Compliance• Process Utilities/Process Equipment• Quality Assurance Documentation• Computer Systems/Automation (PLC/DCS)• Database System Design• Facility Design Criteria• Cleanroom/HVAC Design• Construction Management

Client Benefits• Diversified Technical Resource Pool• Experience-Based Knowledge• Solutions/Results• Lower Project Cost• Resource Planning Flexibility• Additional Resources• Best Value & Quality Service

The PharmTech Advantage

• Manufacturing/cGMP Experience• Established Network Relationships

• Flexible Fee Structure• Customized Protocol Formats • Technical Capabilities• Turnkey Capabilities

Why PharmTech?

Credentialed: 16 year track record in PharmaceuticalsFounded Traceability Solutions Group

Cost Effective: Lump Sum ProposalBudget and project clarity from day 1

We Live in Your Space with an emphasis on;Facilities, compliance, equipment and process

History of delivering ROI We don’t talk about value, we find it!

Project Leadership & Innovation

Michael StewartTraceability & Supply Chain Visibility

Direct (847) 281-8924Cell (815) 403-8425mstewart@PharmTechInc.com

Next Steps…

Technology Integration

Technology: Areas of Focus

Software Validation

Process Automation and Optimization

Computer Systems Validation (CSV)

Documentation and Record Keeping

Workflow Management

Business Analytical Tools

Part II of Electronic Records and Electronic Signature Requirements