Pharmaceutical & Biotech
Quality Management Consulting
12+ years of hands-on experience implementing Quality Management Systems for regulated life sciences companies: TrackWise Digital and Salesforce configuration, version upgrades, validation support, and TrackWise on-premise support.
12+
Years of QMS Experience
70
Pharmaceutical Projects
34
TrackWise Digital Projects
12
Countries
Cumulative figures from the founder's career since 2014.
Quality &
Technology Consulting
Consulting for the pharmaceutical and life sciences industry, combining QMS experience with software development.
TrackWise Digital & TrackWise
Support for TrackWise Digital on the Salesforce Platform and for TrackWise on-premise: version upgrades, validation, module configuration, user training and archiving.
- Version Upgrades
- Validation Support
- Module Configuration
- Web Services & SAML
- User & Admin Training
- On-Premise Support & Archiving
Salesforce Development
Salesforce Certified Administrator and Platform App Builder. Custom objects, Flows, Lightning Web Components, Apex programming and configuration migrations.
- Lightning Web Components
- Apex Programming
- Custom Objects & Flows
- Data Migration
- Automation Workflows
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
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 as a cloud service on Amazon Web Services in the European Union.
Complaints, Deviations and CAPA
From complaint intake and deviation to investigation, corrective and preventive action, and effectiveness check.
Change Control
Change requests with assessment, approval, implementation and effectiveness verification.
Audits
Audit plans, internal and external audits, and findings with their responses.
Document Management
Controlled documents with review and approval cycles, versions, and a PDF copy of every approved version.
21 CFR Part 11 e-Signatures
Electronic signatures designed for 21 CFR Part 11, signed with the user ID and password, and kept in 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: change control, complaints management, deviations, investigations, CAPA, audits and supplier quality.
That QMS experience is combined with certified Salesforce development, and solutions are shaped around the constraints of small and mid-size pharma and biotech organisations.
Clients include pharmaceutical manufacturers, biotech companies, and medical device organisations across Europe, the United States, and Latin America.
Adrien Gunes
Founder
12+ years implementing QMS for pharma, biotech and medical device companies in Europe, the United States and Latin America. Started at Sparta Systems (now Honeywell) in 2014. Since 2017, specialized in TrackWise Digital and the Salesforce Platform.
In 2026, he founded Hemeralis QMS, a cloud Quality Management System for small and mid-size pharmaceutical and biotech companies.
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? Use the form below to get in touch.
Message sent.
Thank you for your message.