In regulated labs, compliance isn’t a checkbox at the end of the process. It’s something that has to be true of every action, every entry, and every handoff from the moment work begins.
What would your lab look like if compliance happened automatically — not as extra work, but as a natural byproduct of how your team already works?
What SciNote Does
SciNote embeds compliance into your everyday scientific workflows — audit trails, electronic signatures, access controls, and validated deployment — so that when the inspection comes, you’re not preparing. You’re ready.
Compliance Standards
The FDA’s standard for electronic records and signatures. SciNote meets its technical requirements — immutable audit trails, identity-verified e-signatures, secure access controls — so your digital records carry the same legal weight as paper ones, with a fraction of the administrative burden.
The European equivalent of 21 CFR Part 11, governing computerized systems in GMP environments. SciNote’s architecture and validation documentation support Annex 11 requirements for labs operating under EMA standards.
Good Practice regulations govern how regulated research, manufacturing, and clinical work is documented and controlled. SciNote’s structured workflows, role-based permissions, and version-controlled protocols align with GxP expectations across lab types.
Public Research Institute, Slovenia
What was the deciding factor in choosing to use SciNote?
“The deciding factor was that SciNote combined the electronic lab notebook with integrated document management in a single system. Many competing notebooks at the time had a separate, non-integrated document system, whereas SciNote let us manage our regulated documentation and our records together – and do so on a local installation we could qualify for GMP use.”
“During audits and inspections I feel most time is saved, as the most relevant documents are extremely quickly reachable via SciNote.”
Every task completed, every entry edited, every signature applied — logged automatically, timestamped, and linked to a verified user.
Key Functionality
Immutable audit logs for every user action — edits, completions, status changes, and signatures — captured automatically, tamper-proof, and exportable on demand.
Electronic signatures tied to verified credentials, with timestamp, signer identity, and documented reason — embedded directly in review and approval workflows.
Dual-environment validated deployment with IQ/OQ documentation, version-specific release notes, and structured upgrade support — so your validation never falls behind your software.
A lot of software can log an action. Fewer platforms are built by people who understand why that log matters — what’s at stake when a record is incomplete, what it costs a scientist to reconstruct a timeline under audit pressure, what it means to a lab when the system they trust fails an inspection.
SciNote was built by a team that debates how finished something needs to be before it ships — because they believe what goes into the platform reflects what comes out of it. The compliance features aren’t a module added to satisfy a checklist. They’re designed into the architecture, tested against real regulatory expectations, and supported by a team that stays close to how labs actually work.
When our lead developer talks about what fulfills him, he says it’s knowing he helped someone solve something real. That orientation — toward contribution, toward craftsmanship — is in the code.
Every user action in SciNote generates a timestamped log entry — linked to a specific user account, record, and moment in time. Edits, completions, status changes, file uploads, protocol modifications, inventory logs — all captured, all immutable, all retrievable.
You shouldn’t have to build your audit trail. SciNote builds it for you, continuously, as your team works — so there’s nothing to reconstruct before an inspection, and nothing missing when a reviewer asks.
SciNote’s e-signature workflow requires verified username and password authentication at the point of signing. Each signature captures the signer’s full name, role, timestamp, and documented reason — and becomes a permanent, uneditable part of the record it’s attached to.
Regulatory reviewers don’t just want to see that something was signed. They want to know who signed it, when, why, and whether that person had the authority to do so. SciNote answers all four questions, automatically.
SciNote Platinum customers receive two independent environments — Validation and Production. The validation instance is updated at least four weeks before production, giving your team time to execute IQ/OQ protocols, complete risk assessments, and review all new functionality against your URS — before it touches live data.
Software validation isn’t optional in regulated environments — and it shouldn’t be painful. SciNote’s dual-environment architecture and pre-prepared documentation package means your validation team has what they need from day one, not after a support ticket.
Built For
SciNote’s built-in audit trail has drastically reduced our audit prep time. Reviewers can see every action, who did it, and when — right inside the system.
— Quality Assurance Lead, Global Biotech Company
FAQ
SciNote is built to support your compliance with 21 CFR Part 11 — including immutable audit trails, identity-verified electronic signatures, role-based access controls, and validated deployment options. Final compliance depends on your internal procedures and validation, and our team is available to walk through what that looks like for your specific environment.
No. SciNote’s audit trail is tamper-proof — no changes can be made to logged entries, even by system administrators. This is a foundational design decision, not a setting.
Platinum plan customers receive a full validation package with each release: IQ and OQ templates, completed OQ reports from SciNote’s internal testing, updated URS documentation, and version-specific release notes. Everything your validation team needs, prepared in advance.
Administrators can assign specific roles — reviewer, contributor, QA approver, lab manager — with granular permissions controlling what each user can view, edit, sign, or approve. Access policies, session timeouts, and SSO/LDAP configuration are all available.
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