psi proposal v42 (1) (1)

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 ApplicationsEBR 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


› Materials & equipment management

› Specification and inventory control

› Built-in QA scripts


› Sample management

› Test management

› Specification and inventory control


› Workflow administration

› Reporting

› Query tool

› Custom reports

› Data visualization

› Dashboards

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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

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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 NoValidation Scripts No No No YesPart 11 Compliant ? ? Yes YesBuilt-in QualityChecks No Yes No Yes

Built-in Security No No No YesAudit Log Yes No Yes YesSOPs 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 PageMain 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

http://www.instantgmp.com/_literature_155564/Video_-_InstantGMP-Lite_Demo_1.mp4


Pharmaway 1.0™ MES Demo

Bill of Material



Equipment



Manufacturing Instructions



Master Record Approval



Batch Production Records

psi proposal v42 (1) (1)

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