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ALL RIGHTS RESERVED BY PHARMCLOUD, LLCCONFIDENTIAL – FOR CLIENT PURPOSES ONLY ALL RIGHTS RESERVED BY PHARMCLOUD, LLCCONFIDENTIAL – FOR CLIENT PURPOSES ONLY
Collaboration Proposal
San Juan, PR

ALL RIGHTS RESERVED BY PHARMCLOUD, LLCCONFIDENTIAL – FOR CLIENT PURPOSES ONLY
About Us
 At Pharmaceutical Systems International - PSI we’ve leveraged years of
pharmaceutical processes, validation, qualification and IT experience to
provide a unique approach to the GMP and Biopharmaceutical process
consulting. We also created an industry first web based GMP complaint
and integrated software suite environment including an MES, LIMS,
Change Control, None Conformance/CAPA and BI system perfect for the
biotechnology, biomedical and pharmaceutical industries.
 With our alliance with PharmaDirections and as a Microsoft Cloud Partner
we are leading the way in FDA validated cloud and web based software
solutions for the Pharmaceutical and Biotech Industry.

Executive Overview – Our Opportunity
We have sized an unique opportunity in the biotech and pharmaceutical
industry to deliver a pillar for operational excellence.
We are convinced that moving critical components of manufacturing,
quality, and compliance systems to the cloud can be immensely impactful.
 Centralized and fully digitized validation
 Increased computational efficiency that matches enterprise-scale
infrastructure
 Industry-standard security and redundancy levels
 Zero up-front capital expenditures
 Zero software obsolescence risk
Simplify regulatory compliance effort by delivering validated solutions.
We are focused on manufacturing have so far limited themselves to
individual ‘vertical’ solutions, bypass the opportunity to deliver an
integrated ‘horizontal’ solution.

Integrated Suite of Applications
EBR LIMS Business Intelligence /
Reporting
› Fully Part 11
and GMP
compliant
› Built-in QA
scripts
Change
Control/NC CAPA
Full MES
FDA-validated Private Web-Hosting Partner
› Fully Part 11
and GMP
compliant
› Materials &
equipment
management
› Specification
and inventory
control
› Built-in QA
scripts
› Fully Part 11
and GMP
compliant
› Sample
management
› Test
management
› Specification
and inventory
control
› Fully Part 11
and GMP
compliant
› Workflow
administration
› Reporting
› Query tool
› Custom
reports
› Data
visualization
› Dashboards
Our Product BlueprintKeyFeatures

Executive Overview – Our Strategic Proposal
1.Be the first and most aggressive player to go after this opportunity.
2.Explore partnering with local companies such as Pharma-Bio Serv
(FDA validation) or Paciv (project management) to leverage their
domain expertise and global reach in the pharmaceutical industry.
3.Develop and bring to market a world-class suite of integrated
solutions by Spring 2014.
4.Partner with an Angel Client (i.e Therapeutic Proteins Internationals
in Chicago) to finalize software integration and validation during the
commercialization phase of the facility
5.Pursue ‘Wave 1’ opportunities leveraging the team’s global network
of biotech and pharmaceutical partners.

Scope of Proposed Collaboration & Expected
Benefits – Angel Client
› Allow PSI team access to Therapeutic
Proteins International data and process flows
› Allocate hours required to develop for Master
Data configuration and MBR templating for
MBR development, testing and validation
› Partner with PSI to show case marketing and
sales efforts for a two-year period (scope to
be defined)
› Finalize build of individual solutions on
Azure cloud
› Test / finalize integration of full suite of
applications
› Pay for TPI’s validation
› Deliver a validated core of applications
› Deploy solution for TPI on Azure-hosted
private cloud
› Savings through startup due to Pharmaway
sponsored FDA validation and foregone CapEx
from hosted infrastructure
› Reduced recurring OpEx due to lower long-term
cost of ownership
› Built operational excellence in manufacturing
execution
› Develop a delivery model for start –up
operations
› First –hand feedback from manufacturing
and quality will improve our design of core
applications improvement
› Use of client name and ‘use case’ for
commercial purposes
CommitmentsBenefits
Client

PSI Team:
› Jaime Arraya – Account Executive
› Juan C Tirado – Project Manager
› Alexis Normandia – EBR Programmer
Milestones and Timeline/Client Project

MES System Comparison HITPHAMS Honeywell-POMS Werum **Pharmaway 1.0
System Client/Server
.NET
Client/Server Web-based
Recipe Development Yes
No Yes
Yes
Weigh & Dispense
Yes Yes
Yes
Yes
Material Control Yes
Yes Yes Yes
Inventory Control
Yes Yes Yes Yes
Spec Control
No No Yes Yes
Purchasing
Yes No Yes Yes
Equipment Log
No No No Yes
Room Log
No No No Yes
MPR & BPR*
BPR BPR
MPR & BPR MPR & BPR
Scheduling Yes Yes Yes No
Validation Scripts No No No Yes
Part 11 Compliant
? ? Yes Yes
Built-in Quality
Checks
No Yes No Yes
Built-in Security No No No Yes
Audit Log Yes No Yes Yes
SOPs Included
No No No Yes
Includes SOPs/Policies
No
No No Yes
How our MES Compare Against Leading MES Software?

Rationale for Cloud Computing in Biotech & Pharma
› Biotech and pharmaceutical systems have always been highly complex and expensive.
› Hardware and software requirements are daunting in scale, variety, and speed of obsolescence.
› They also require large teams of experts for installation, configuration, testing, operation,
security, and maintenance.
› When you scale this effort across dozens or sometimes hundreds of applications, it’s easy to see
why the largest companies with the best IT departments aren’t getting the systems they need.
› Small and mid-sized businesses don’t stand a chance….
› Cloud computing eliminate these headaches because companies are no longer required to own
and manage hardware and software.
› Shared infrastructure makes hardware and software function as a utility: companies pay only for
what they need, upgrades / updates are automatic, and scaling is easy.
› Cloud-based applications can be up and running in a fraction of the time it takes to ramp up a
client-hosted stack, and they cost far less. Users just open a browser, log in, customize their app,
and get back to work!
› Businesses are already running all types of mission-critical apps in the cloud such as customer
relationship management (CRM), HR, accounting, and much more.
Problem
Solution

Pharmaway 1.0™ Demo
 The Microsoft web based infrastruture is in place.
 The MES, LIMS, Change Control and BI systems are installed in the web server.
 Our prelicensed individual systems in the cloud are ready to be used “video”.
 The Pharmaway 1.0™ suite can be fully validated and integrated by Q1 2014.
Pharmaway 1.0™ Home Page
Main Menu. Included
Set up , Planning, and
Quality Management
items like plan orders,
batches status , etc
This bench included the
connection to the others
solutions included in the
suite: MES, LIMS, BI, etc

Pharmaway 1.0™ MES Demo
Bill of Material

Equipment

Manufacturing Instructions

Master Record Approval

Batch Production Records

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