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A standalone, compliance-first electronic signature solution that you can run on its own, connect to the Cloudbyz eClinical platform, or integrate directly into the systems you already use. One Part 11 grade signing standard, deployed your way.
Today we are announcing the general availability of Cloudbyz eSign, a 21 CFR Part 11 compliant electronic signature solution designed from the ground up for life sciences and other regulated industries.
Cloudbyz eSign is a standalone product. You can use it entirely on its own as a dedicated compliant signing tool, you can pair it with the Cloudbyz eClinical platform for a unified clinical, regulatory, quality, safety, and finance experience, or you can integrate it into your existing systems such as EDC, CTMS, eTMF, QMS, DMS, ERP, or your own internally built applications. The compliance does not change based on where you deploy it. The Part 11 controls are native to the product itself, so a signature is exactly as trustworthy and defensible whether it happens inside Cloudbyz eSign, inside Cloudbyz eClinical, or inside a system of your own.
For pharma, biotech, CROs, SMOs, medical device, diagnostics, and cosmetics organizations, an electronic signature is never just a signature. It is a regulated event that must be attributable, secure, and defensible for decades. This launch reflects a simple conviction: a signature solution for regulated work should be engineered for regulated work, and it should meet you where your work already happens rather than forcing you to move your work to it.
Why a generic eSignature tool is the wrong foundation for regulated work
The market is full of electronic signature products that carry a "Part 11 compliant" label. It is worth being precise about what that label actually means, because in regulated industries the gap between a marketing claim and a defensible control is the gap between passing an inspection and receiving a Form 483.
Here is the reality that seasoned quality and regulatory leaders already know.
There is no FDA certification for Part 11 compliance. No agency issues a badge, and no third party defines a minimum technical threshold. Every vendor that makes the claim is self-certifying. What matters is the specific technical control and how it maps to the regulation text, not the words on the pricing page.
Compliance is a shared responsibility. No software product can make an organization compliant on its own. Many Part 11 obligations sit with the regulated entity: validation, standard operating procedures, access governance, and correct configuration. A good vendor reduces that burden dramatically. A vendor who claims to remove it entirely is overselling, and any team that has lived through an inspection knows it.
Compliance-first design beats a compliance add-on. This is the point most buyers underestimate. Many popular signing tools began as general-purpose or consumer products and later attached Part 11 features through a separate paid module. When compliance is an optional layer on a system that was not built for regulated use, there is a structural risk that the platform can be operated without those controls, which makes validation more complex and more fragile. Cloudbyz eSign is the opposite. It was built for regulated work first, so the Part 11 controls are not a toggle you enable and could accidentally bypass. They are the foundation of the product in every deployment mode.
The most common real-world gap is authentication at the moment of signing. Section 11.200(a) requires two distinct authentication components to be applied at the time the signature is executed, not merely at login. Many general-purpose tools authenticate a user once at session start and then allow unlimited signing. That fails the requirement. It is one of the first things a knowledgeable inspector probes, and it is one of the first things a knowledgeable buyer should test.
Cloudbyz eSign was built with these truths as the starting point rather than as an afterthought.
What Cloudbyz eSign delivers
Cloudbyz eSign implements the electronic signature and electronic record controls of 21 CFR Part 11 as native, non-bypassable behavior of the product, and it carries that same behavior into every place you deploy it.
Two-factor authentication at every signing event. Authentication components are required at the point of signing, every time, regardless of how long ago the user logged in. This is the control that separates a genuine Part 11 signature from a convenience feature.
Signature manifestation with meaning. Every signed record displays the printed name of the signer, the date and time the signature was executed, and the regulated meaning of the signing action, such as approval, review, authorship, or responsibility. Signature meanings are configurable to match your standard operating procedures.
Unbreakable signature-to-record linking. Signatures are cryptographically bound to the specific record content at the time of signing, so they cannot be excised, copied, or transferred to falsify a record. If content changes, the integrity of the signature is protected.
Tamper-evident, independent audit trails. Every create, modify, and delete action is captured in a computer-generated, time-stamped audit trail that records the original value, the new value, the actor, and a reason for change. The audit trail is designed to detect unauthorized modification rather than merely restrict access to it.
Unique identity and disciplined access control. Every signature is unique to one individual and is never reused or reassigned. Account lifecycle management preserves history when personnel change, session timeouts and lockout controls limit exposure, and shared accounts have no place in the model.
Long-term retention and open export. Records and their audit trails can be retained across the multi-decade horizons that clinical and quality records require, and exported in formats that remain readable independent of the originating software.
Vendor-supplied validation documentation. Cloudbyz provides validation artifacts and change notifications so that customer quality teams are not forced to author IQ, OQ, and PQ protocols from scratch, and are not surprised by changes that would require revalidation.
The value: one compliant signing standard, deployed your way
The defining advantage of Cloudbyz eSign is flexibility without compromise. You get the same rigorous, inspection-ready signature no matter how you choose to run it, which lets you standardize on a single compliant signing capability across your entire organization instead of tolerating different signing behaviors in different tools.
Deploy it standalone. For teams that need dependable, compliant signing without a larger platform commitment, Cloudbyz eSign works on its own from day one. Route documents, capture Part 11 signatures with meaning, and maintain a complete audit trail, all without adopting anything else.
Pair it with Cloudbyz eClinical. When used alongside the Cloudbyz unified platform, signing happens in the same environment as your clinical, regulatory, quality, safety, and finance records. The signed artifact and the system of record never disagree, quality records stay inside a validated environment, and the signing event shares one coherent audit trail with the surrounding work. That coherence is the difference between a confident afternoon and a difficult week during an inspection.
Integrate it into the systems you already have. Cloudbyz eSign connects to your existing EDC, CTMS, eTMF, QMS, DMS, ERP, or homegrown applications, so signing happens in context, inside the tools your teams already use. There is no rip and replace, and there is no swivel-chair between a separate signing application and your real systems of record. You bring compliant signing to your stack rather than reshaping your stack around a signing tool.
Standardize and simplify. Running one Part 11 grade signing standard everywhere means one set of controls to understand, one validation approach to maintain, and one audit story to tell. That consistency lowers total cost of ownership in the places that actually cost money: validation effort, revalidation frequency, SOP workarounds, integration maintenance, and the risk of a citation. The sticker price of a signing license is rarely the real cost. The real cost is everything around it, and a compliance-first, interoperable design compresses all of it.
Move faster without a compliance penalty. Approvals, protocol sign-offs, training records, quality decisions, and consent related signatures move at the speed of digital work while remaining fully attributable. Teams get the convenience they expect from modern software and the rigor their regulators require, at the same time.
This launch meets a sharpening regulatory moment
The timing is deliberate. The environment around regulated electronic records is tightening in three directions at once.
Enforcement is intensifying. Data integrity remains a stated FDA enforcement priority, inspection activity has risen, and audit trail review and system access controls are recurring themes in observations. The scope of what counts as a regulated electronic record is also widening as data from digital health technologies and connected devices flows into sponsor systems.
Global expectations are converging. As the European Union advances its GMP Annex 11 revision, multi-factor authentication at each signature and formal supplier qualification are moving from good practice to explicit expectation. Organizations that operate across jurisdictions increasingly need a signature capability that satisfies both the FDA and European frameworks without a second tool and a second validation effort.
Clinical research is going digital at scale. The rise of decentralized and hybrid trials, and the rapid adoption of electronic consent, means that Part 11 grade signature capture with strong identity verification, timestamping, and complete audit trails is now foundational rather than optional. Signatures are no longer an occasional event. They are woven through the entire regulated workflow.
Cloudbyz eSign is built for exactly this moment: a compliance-first signature capability that scales with the digitization of regulated work and adapts to whatever systems that work runs on.
A word from Cloudbyz
"We built Cloudbyz eSign to give regulated organizations the best of both worlds: uncompromising compliance and complete freedom in how they work," said Dinesh Kashyap, Chief Executive Officer of Cloudbyz. "It is compliance-first by design and flexible by design. Run it on its own, run it with our eClinical platform, or bring it straight into the systems you already trust. The signature is exactly as defensible everywhere, and inspection readiness is built in from the start. This is what modern life sciences teams deserve: the confidence to move fast and the assurance that every signature will hold up to scrutiny."
Availability
Cloudbyz eSign is available now. You can adopt it as a standalone compliant signing solution, enable it alongside the Cloudbyz eClinical platform across CTMS, eTMF, EDC, CTFM, Safety and Pharmacovigilance, and Patient Recruitment, or integrate it into your existing systems through our APIs and connectors.
To see Cloudbyz eSign in the context of your own processes, request a walkthrough with our team. We will show you not only how the signature works, but how it holds up under the scrutiny that regulated work demands, in whichever way you choose to deploy it.
Cloudbyz is a Salesforce native unified eClinical platform for pharma, biotech, CRO, SMO, medical device, diagnostics, and cosmetics organizations, spanning CTMS, eTMF, EDC, CTFM, Safety and Pharmacovigilance, and Patient Recruitment, with a portfolio of AI agents built on Salesforce Agentforce.
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