The eQMS built for teams who live by 21 CFR Part 11.
RegSage gives quality and regulatory teams audit-ready document control, e-signatures and CAPA — with tamper-proof WORM evidence built in.
Walk into your next inspection as the team that's ready — not the team that's scrambling.
Your quality system shouldn't fight you.
When records live in spreadsheets, shared drives and signature binders, every audit becomes a fire drill — and the people who care most about quality spend their time chasing paper instead of improving it. RegSage replaces the scramble with a single, controlled source of truth.
Everything a quality team needs, connected.
Purpose-built modules that map to how regulated teams actually work — not a generic workflow tool bent into shape.
Document control
Controlled documents with enforced review/approval workflows, automatic versioning, and effective-date management — one source of truth that replaces shared drives, email and signature binders.
Electronic signatures
Part 11 e-signatures with PIN authentication and signing meanings, cryptographically sealed to the exact record revision being signed — not just "Part 11 compliant," but verifiably bound.
CAPA, risk & complaints
Non-conformances, CAPAs, complaints and ISO 14971 risk management — linked end to end so cause, action and verification stay connected.
Audit-ready evidence
A cryptographically-chained, tamper-evident audit trail over immutable WORM records — so the evidence an inspector asks for already exists, intact, and is produced on demand.
Design control
Design history files, design reviews, and traceability across requirements and risk.
Change control & approvals
Route change requests through configurable approval gates with signature requirements.
Training records
Assign read-and-understand training to document revisions; track completion and quizzes.
Supplier quality
Maintain approved supplier lists and link supplier records to quality events.
Full-text search & export
Find any record fast and export audit trails for inspectors on demand.
Role-based access
Granular RBAC and strict org isolation so people see only what they should.
Built and backed by people who've sat on both sides of the table.
RegSage is shaped by former FDA reviewers, device engineers, and quality leaders — including Certified Quality Auditor Marnie Junker, with 30+ years guiding regulated companies through inspections. That experience is in the product: a tamper-evident, cryptographically-chained audit trail, immutable WORM records, and Part 11 signatures sealed to the exact revision.
- Former FDA medical officers & reviewers
- Certified Quality Auditors with 30+ years in regulated quality
- Device & drug-device engineers across full product lifecycles
- One team for the software and the strategy
Your path to audit-ready, in three steps.
Author & control
Draft SOPs, work instructions and records in a controlled workspace with automatic version history.
Review & e-sign
Route for review and Part 11 e-signature. The approved revision becomes effective and immutable.
Stay audit-ready
Every action is logged to a tamper-evident trail and every record sealed in WORM storage — automatically.
Records that can't be altered or back-dated.
RegSage was designed from the storage layer up for data integrity — supporting the ALCOA+ principles regulators expect. Controlled records are immutable from the moment they're signed, and every change is provable.
- Tamper-evident, cryptographically chained audit trail
- WORM storage with retention locks (Object Lock)
- Part 11 e-signatures bound to record revisions
- Role-based access & strict org isolation
- Encryption in transit and at rest
- Hosted on AWS · SOC 2 program in progress
“As a company creating combination products, we need a system that supports pharmaceutical, medical device, and software products equally well. RegSage gave us SOP templates, controlled documents, Part 11 signatures and a tamper-evident audit trail in weeks — not the six-month enterprise rollout we feared.”
Priced by where you are in your journey.
Plans scale with your product lifecycle. Every tier includes the tamper-evident audit trail and immutable WORM storage — compliance isn't an upsell.
Foundational
The controlled foundation.
- Document control & versioning
- Part 11 electronic signatures
- Training records & quizzes
- Tamper-evident audit trail
- Immutable WORM storage
- Role-based access control
Submission-Ready
Everything in Foundational, plus design & risk.
- Design control (DHF, reviews, traceability)
- ISO 14971 risk management
- Supplier quality
- Change control & approval gates
Post-Marketing
The full quality system.
- CAPA & non-conformances
- Complaints handling
- Internal & supplier audits
- Full-text search & audit export
Enterprise
SSO, validation support, dedicated success, and consulting bundles for larger or multi-site teams.
Prices shown are for annual billing and may be tailored to your modules and team size.
The cost of records you can't trust.
Audit findings, warning letters and delayed submissions almost always trace back to the same root cause: records that couldn't be trusted, or couldn't be found. RegSage removes that risk by design — so quality work builds your product instead of defending it.
Frequently asked
Is RegSage 21 CFR Part 11 compliant?+
RegSage is built specifically to support Part 11 and EU Annex 11 controls — electronic signatures, audit trails, access controls and record integrity. We provide the technical controls; your validated procedures complete the compliance picture.
What makes the records tamper-proof?+
Controlled documents and signatures are written to write-once, read-many (WORM) object storage with retention locks, and every change is recorded in a cryptographically chained audit trail. Records cannot be silently altered or deleted.
How long are records retained?+
Controlled records follow a life-of-product + 5 year retention policy by default, enforced at the storage layer so retention cannot be shortened.
Can we migrate from our current system?+
Yes. We help teams move off paper, shared drives and legacy eQMS tools — and our consulting team can run the migration with you. Book a demo and we will scope it.
Ready to make audits boring?
See RegSage with your own quality records. Book a 30-minute demo — and walk away with a clearer path to audit-ready.