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INSTANT QUALITY MANAGEMENT SYSTEM

FOR BIOTECH & PHARMA

Be audit-ready in every way with the best QMS for FDA, ISO and GxP Compliance.
Doc Control, Training, CAPAs, Audits, Complaints…

#1 Cloud-based Quality Management Software

for Biotech & Pharma

Be audit-ready in every way with the best QMS solution for FDA, ISO and GxP Compliance. Doc Control, Training, CAPAs, Audits, Complaints...

Problems and Solutions

Problem

Investors, Regulators, and Business Partners alike want reliable, proven data

Lacking internal resources

Urgency to prove the business hypothesis works and should receive further funds/partnerships

Consulting services is expensive and may disrupt the business

Solution

QUASY allows Start-Ups and SMEs to overcome regulatory hurdles quickly and easily to implement a standardized but customized quality management system (QMS).

The content is generated automated based on the input of a query mask and verified by a specialist before the document is sent to the customer.

This is possible within a few days instead of previously many months to take.

The system is accompanied by training videos and personal coaching sessions to ensure that the customer can interpret and use the system correctly.

Current Situation
and competitors

The solution developed in this project offers an interactive but standardized solution that reduces time and costs on both sides and ensures conformity with the regulations and/or ISO standards. The system is designed in such a way that a timely certification is possible. Discussions with possible certification partners are already underway.

So far, a prototype of the system has already been

created and alpha testing has been successfully completed.

Strategic market entry is in the DACH region. A first customer is ready and we are currently working out the commercial aspects. In the roll-out of the solution, we will focus exclusively on pharmaceutical and biotech SMEs. A later horizontal expansion into other areas with comparable ISO requirements is also conceivable, and can be implemented with manageable effort.

Generate functioning product & reliable data to reduce costs & burn rat

Small businesses should focus on core competencies; avoid business interruptions by setting up compliance structures themselves.

Implementing a QMS timely for increased value, cost reduction and success.

ISO certification in a timely manner with lean, standardized process improves your valuation and success rate

Medium-sized companies researching or wanting to enter the life sciences sector can quickly do so with the solution offered here.

Packages

Packages and Pricing.
All of them can be purchased alone or in combination with another one.

€ Inquire Module

Anything being a part of a QMS

€ Inquire

Based on cGXP
Based in ISO 9001
Based on ISO 13485
Get a validated Cloud System along with it

€ Inquire

If you feel basic is not gonna cut it
add a eQMS from our partners
I need extra help. - Ask for Quality as a Service.

€ Inquire

Migrate the System into the cloud and validate it
ZenQMS
Intellect

TIMELINE

Day1

Templates
Quality Manual
Quality Policy
Organigram Communication Charts
Document Creation and Lifecycle
Change Control

Day2

Raw Mats
Equipment
Deviation Mgmt.
CAPAs
Procurement + Inventory Controls

Day3

Internal Auditing
CVs, JDs, Training
Indexing
Archiving
Data Management

Day4

Computerized Systems
IT Procedures
MiBi

Day5

Document Completion
Training Start

Day1

Kick-off & Questionnaire + Status evaluation

Day2

Qual.+ Validation
Practice+ Control
Risk Management
Supplier qualification
Material qualification

Day3

CMC/TT SOPs
Manufact. Docs
QC Docs
Supplier Mgmt., QAA

Day4

Pest Control
Facility Management
Access Controls
Complaint Management
Recalls

Day5

GCP
KPIs, Monitoring
Assessment Tools

Client Dependent

Completion of all training

Go Live!

Project Closure

Support & Inspection Scheduling

Contact Us

Website

www.quasy.net

E-mail

sales@quasy.net

For Quality as a Service inquire at office@austrianpharmaservices.com

Contact Form Demo

First Name

Last Name

Subject

Your Message

INSTANT QUALITY MANAGEMENT SYSTEM

FOR BIOTECH & PHARMA

#1 Cloud-based Quality Management Software

for Biotech & Pharma

Be audit-ready in every way with the best QMS solution for FDA, ISO and GxP Compliance. Doc Control, Training, CAPAs, Audits, Complaints...

Problems and Solutions

Problem

Investors, Regulators, and Business Partners alike want reliable, proven data

Lacking internal resources

Urgency to prove the business hypothesis works and should receive further funds/partnerships

Consulting services is expensive and may disrupt the business

Solution

QUASY allows Start-Ups and SMEs to overcome regulatory hurdles quickly and easily to implement a standardized but customized quality management system (QMS).

The content is generated automated based on the input of a query mask and verified by a specialist before the document is sent to the customer.

This is possible within a few days instead of previously many months to take.

The system is accompanied by training videos and personal coaching sessions to ensure that the customer can interpret and use the system correctly.

So far, a prototype of the system has already been

created and alpha testing has been successfully completed.

Medium-sized companies researching or wanting to enter the life sciences sector can quickly do so with the solution offered here.

Packages

Individual QMS modules

Standardized
system

Personalized system

eQMS

TIMELINE

Day1

Day2

Day3

Day4

Day5

Day1

Day2

Day3

Day4

Day5

Client Dependent

Go Live!

Contact Us

Website

E-mail

INSTANT QUALITY MANAGEMENT SYSTEM

​FOR BIOTECH & PHARMA​

#1 Cloud-based Quality Management Software ​

for Biotech & Pharma

Be audit-ready in every way with the best QMS solution for FDA, ISO and GxP Compliance. Doc Control, Training, CAPAs, Audits, Complaints...​

Problems and Solutions

Problem

Investors, Regulators, and Business Partners alike want reliable, proven data ​

Lacking internal resources

Urgency to prove the business hypothesis works and should receive further funds/partnerships​

Consulting services is expensive and may disrupt the business ​

Solution

QUASY allows Start-Ups and SMEs to overcome regulatory hurdles quickly and easily to implement a standardized but customized quality management system (QMS).

The content is generated automated based on the input of a query mask and verified by a specialist before the document is sent to the customer. ​

This is possible within a few days instead of previously many months to take.​

The system is accompanied by training videos and personal coaching sessions to ensure that the customer can interpret and use the system correctly.​

So far, a prototype of the system has already been​

created and alpha testing has been successfully completed.​

Medium-sized companies researching or wanting to enter the life sciences sector can quickly do so with the solution offered here.

Packages

Individual QMS modules

Standardized system​

Personalized system

eQMS

TIMELINE

Contact Us

Website

E-mail

FOR BIOTECH & PHARMA

#1 Cloud-based Quality Management Software

Be audit-ready in every way with the best QMS solution for FDA, ISO and GxP Compliance. Doc Control, Training, CAPAs, Audits, Complaints...

Investors, Regulators, and Business Partners alike want reliable, proven data

Urgency to prove the business hypothesis works and should receive further funds/partnerships

Consulting services is expensive and may disrupt the business

The content is generated automated based on the input of a query mask and verified by a specialist before the document is sent to the customer.

This is possible within a few days instead of previously many months to take.

The system is accompanied by training videos and personal coaching sessions to ensure that the customer can interpret and use the system correctly.

So far, a prototype of the system has already been

created and alpha testing has been successfully completed.

Standardized
system