Annature, Australia’s main eSignature and identification verification supplier, has introduced the discharge of its 21 CFR Half 11 compliant digital signature module, enabling organisations working in FDA‑regulated environments to execute digital data with confidence.
The brand new functionality ensures Annature prospects can meet the U.S. Meals and Drug Administration’s necessities for digital data and digital signatures underneath 21 CFR Half 11, a regulation that governs knowledge integrity, signer authentication, and auditability throughout industries equivalent to life sciences, prescription drugs, biotechnology, and scientific analysis.
The discharge has been pushed by rising demand from U.S.-based and multinational organisations looking for a contemporary, compliant different to legacy eSignature platforms. A number of prospects working in regulated environments have already transitioned to Annature as a part of broader digital transformation initiatives, prompting the corporate to formally introduce Half 11 help as a part of its worldwide product roadmap.
“As we proceed to develop globally, it’s essential that Annature helps the regulatory frameworks our prospects function underneath,” mentioned Corey Cacic (pictured), CEO of Annature. “Our 21 CFR Half 11 module permits organisations topic to FDA necessities to make use of Annature with confidence, realizing their digital signatures meet the required compliance requirements.”
The module introduces controls aligned with Half 11 expectations, together with safe signer authentication, tamper‑evident audit trails, and powerful linkage between digital signatures and the data they relate to. These options guarantee digital signatures executed by way of Annature could be relied upon in regulated workflows and through regulatory assessment.
Kim Metal, Founder and Managing Director of SAPRO – a boutique CRO supporting area of interest biotech and pharmaceutical corporations with commercially sponsored Part I–III full-service scientific trials has welcomed the discharge.
“For organisations working in regulated environments, compliance with 21 CFR Half 11 isn’t non-obligatory – it’s basic,” mentioned Metal. “It’s encouraging to see Annature, an Australian know-how supplier supporting worldwide regulatory necessities which are essential to our trade and our purchasers. Options like this allow sponsors to function confidently on a worldwide stage, with out reliance on outdated or overly complicated legacy methods, whereas remaining inspection and audit-ready always.”
The launch additional strengthens Annature’s place as a worldwide‑prepared eSignature platform, supporting organisations that function throughout jurisdictions with various compliance obligations. The 21 CFR Half 11 module is obtainable now and could be enabled for patrons who require FDA‑compliant digital signatures.
