Pharmaceutical & Biotech
Quality Management Consulting
12+ years of hands-on experience implementing Quality Management Systems for regulated life sciences companies: quality process design, QMS implementation, version upgrades, validation support, and support of existing systems, including TrackWise and TrackWise Digital.
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.
Quality Management Systems
Over 12 years designing and implementing quality processes at international pharmaceutical companies, including the move from paper-based processes to an electronic QMS.
- Deviations & CAPA
- Change Control
- Complaints Management
- Audits & Supplier Quality
- Document Management
- From Paper to eQMS
QMS Implementation & Validation
Implementation, configuration and upgrades of electronic Quality Management Systems, with the validation support a regulated environment requires.
- Configuration & Automations
- Version Upgrades
- Configuration Migrations
- Validation Support
- User & Admin Training
TrackWise & TrackWise Digital
Support and development for existing TrackWise systems: TrackWise on-premise, and TrackWise Digital on the Salesforce Platform. Salesforce Certified Administrator and Platform App Builder.
- On-Premise Support & Archiving
- Flows & Apex
- Lightning Web Components
- Custom Objects
- Web Services & SAML
Hemeralis QMS
A cloud-based Quality Management System designed for small 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 experience covers both the quality processes and the systems that run them, including TrackWise and TrackWise Digital, and solutions are shaped around the constraints of each organization.
Clients include pharmaceutical manufacturers, biotech companies, and medical device organizations 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 2018, specialized in TrackWise Digital and the Salesforce Platform.
In 2026, he founded Hemeralis QMS, a cloud Quality Management System for small 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.
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