Make your device Annex 11-ready
Our experts guide you from gap assessment to full compliance using proven SDLC practices, helping you become audit-ready and trusted by pharma partners.
GMP Annex 11 is changing. Are your devices ready?
GMP Annex 11 and FDA 21 CFR Part 11 are evolving to ensure data integrity, system reliability, and full traceability.
If your software or device doesn’t meet the new standards, you risk audit failures, product rejections, and loss of pharma partnerships.
Update your documentation, validation, and risk management processes, so you’re inspection-ready and market-compliant.
For vendors operating in regulated environments
If your product interacts with regulated data, instruments, or processes, Annex 11 compliance is your entry ticket to the pharma market.
Our Annex 11 consulting and development services are designed for:
Medical device and diagnostic instrument manufacturers
Life science and laboratory software providers (LIMS, ELN, CDS)
Pharma and biotech suppliers (GMP and non-GMP environment)
Quality and regulatory teams ensuring supplier compliance
Start-ups or scale-ups entering regulated markets
We help you meet Annex 11 and 21 CFR Part 11 requirements
We partner with device and software manufacturers to build, verify, and maintain solutions that meet the latest GMP Annex 11 and FDA 21 CFR Part 11 requirements.
What we offer:
✔ Gap assessment
✔ Documentation preparation for (GMP Annex 11, 21 CFR Part 11, IVDR)
✔ Software product or missing feature development following good SDLC practices
✔ Verification and validation (internal testing and preparation of test reports)
✔ QMS-based development under ISO 9001 standards
✔ Ongoing maintenance and support to sustain compliance
Whether you need a full validation strategy or targeted compliance upgrades, we tailor our services to your needs.
Schedule your free consultation
Let’s make your system Annex 11-ready. Schedule a free 30-minute call to discuss your current processes and outline your roadmap to compliance.
Our experts will help you identify gaps and practical next steps based on years of experience supporting regulated software projects.
Your path to Annex 11 readiness
We support you in every step of the way: from gap analysis to complete Annex 11 compliance.
Gap assessment
Identify where your current system stands versus Annex 11 requirements.
Roadmap design
Define the technical and documentation steps needed for compliance.
Implementation
Develop or adapt your software following SDLC and QMS best practices.
Verification & validation
Test, document, and prepare audit-ready reports.
Maintenance
Keep your system compliant with continuous updates and support.
Why companies trust BioSistemika
We combine regulatory knowledge with deep software development expertise to help you meet compliance requirements efficiently and confidently.
Regulatory and technical expertise
Our team understands compliance frameworks (GMP Annex 11, FDA 21 CFR Part 11, IEC 62304, ISO 13485)
Proven experience in regulated environments
We’ve supported numerous life science and medical device companies in achieving and maintaining compliance.
End-to-end support
From gap assessment to verification and maintenance, we guide you through every step of the lifecycle.
Tailored solutions
Every system and process is different; our approach is adapted to your specific product and regulatory needs.
Trusted by global clients
BioSistemika partners with leading pharmaceutical, biotech, and diagnostic organizations worldwide.
Continue your compliance journey
Stay informed and ready for regulatory changes with our latest resources.
Learn about our 21 CFR Part 11 consulting services
Discover how we help companies meet FDA requirements.
Read our blog article on implementing 21 CFR Part 11 features
Explore insights on implementing 21 CFR Part 11 features and ensuring data integrity.
Watch our expert webinar on demand
Hear from our specialists on practical strategies for 21 CFR Part 11 feature implementation and validation.
