INSTANT QUALITY MANAGEMENT SYSTEM
FOR BIOTECH & PHARMA
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
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.
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.
All of them can be purchased alone or in combination with another one.
Individual QMS modulesYou already have basic documents and want to elaborate
Anything being a part of a QMS
80:20, Instant System, to get the ball rolling
Based on cGXP
Based in ISO 9001
Based on ISO 13485
Get a validated Cloud System along with it
Personalized systemwith or without eQMS
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.
eQMSmove the system directly into the cloud and have it validated
Migrate the System into the cloud and validate it
- Quality Manual
- Quality Policy
- Organigram Communication Charts
- Document Creation and Lifecycle
- Change Control
- Qual.+ Validation
- Practice+ Control
- Risk Management
- Supplier qualification
- Material qualification
For Quality as a Service inquire at email@example.com