Pharmaceutical & Medical Device
Quality Management Consulting
12+ years of hands-on experience implementing Quality Management Systems for regulated life sciences companies — from quality process design to system validation, and TrackWise implementations and upgrades.
12+
Years of QMS Experience
70
Pharmaceutical Customers
34
TrackWise Digital Customers
12
Countries
Quality &
Technology Consulting
Consulting for the pharmaceutical and life sciences industry, combining QMS experience with software development.
Quality Management Systems
Over 12 years implementing quality processes at international pharmaceutical companies — change control, complaints, deviations, investigations, audits and supplier quality.
- Change Control
- Complaints Management
- Deviations & CAPA
- Supplier Quality Management
- Audit Management
Salesforce Development
Certified Salesforce ISV Partner. Custom object development, Lightning Web Components, APEX programming, configuration migrations and automation.
- Lightning Web Components
- APEX Programming
- Custom Objects & Flows
- Data Migration
- Automation Workflows
TrackWise QMS Solutions
Support for cloud-based (Salesforce) and on-premise TrackWise deployments — version upgrades, validation, module configuration and user training.
- Version Upgrades
- Validation Support
- Module Configuration
- Web Services & SAML
- User & Admin Training
Hemeralis QMS
A cloud-based Quality Management System designed for small and mid-size pharmaceutical and biotech companies.
Designed with GxP, 21 CFR Part 11 and GDPR requirements in mind, and operated by us as a cloud service for life sciences companies.
Audit Management
Audit planning and execution — internal and external workflows, findings management and reporting.
CAPA Module
The corrective and preventive action lifecycle, from audit findings through root cause analysis to effectiveness verification.
21 CFR Part 11 e-Signatures
Electronic signatures designed for 21 CFR Part 11, with two-factor authentication and a tamper-evident signature chain.
GxP Audit Trail
A hash-chained, append-only audit log, designed to keep tamper-evident records for GxP audits.
12+ Years in Pharmaceutical Quality & Technology
GÜNES CONSULTING OÜ draws on over 12 years of hands-on experience defining and implementing Quality Management Systems at international pharmaceutical companies — spanning change control, complaints management, deviations, investigations, CAPA, audits and supplier quality.
We combine that QMS experience with certified Salesforce development, and shape solutions around the constraints of small and mid-size pharma and biotech organisations.
Our clients include pharmaceutical manufacturers, biotech companies, and medical device organisations across Europe, the United States, and Latin America.
12+
Years of QMS Experience
Pharma
& Biotech Focus
EU · US
& LATAM Clients
GxP
Regulated Environments
Working Across Languages
Working with clients in Europe, the United States and Latin America, across languages and regulatory frameworks.
Let's Work Together
Looking to improve your quality management processes or implement a QMS? Send a message and we will get back to you.
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