21 CFR Part 11: FDA Expectations for Electronic Records & Electronic Signatures in Modern Systems

Overview:

As regulated companies accelerate digital transformation—moving quality, laboratory, clinical, and manufacturing activities into electronic and cloud-based platforms—the stakes around 21 CFR Part 11 have increased. Part 11 is no longer a “once-and-done” compliance exercise tied to on-prem systems. It now sits at the center of how organizations defend data integrity, traceability, accountability, and inspection readiness when records are created, reviewed, approved, and stored electronically across multiple systems, vendors, sites, and distributed teams.

Implementation success has historically been mixed because Part 11 is not simply a technical feature set. It requires a coordinated approach across system safeguards and organizational discipline: unique user identity, role-appropriate access, audit trails that are enabled and governed, records that remain reliable throughout their lifecycle, and electronic signatures that clearly communicate intent (performed, reviewed, approved) with appropriate segregation of duties. Just as importantly, companies must be able to demonstrate—through policies, procedures, training, and supporting evidence—that the ER/ES program is consistently executed, not merely documented.

This webinar translates Part 11 into practical decisions teams face every day: defining the “official record” in hybrid environments, setting expectations with SaaS vendors, scaling assurance without overburdening teams, and avoiding common gaps that lead to observations—such as shared accounts, weak audit-trail governance, unclear signature meaning, inconsistent procedures, and poor change control. Attendees will leave with a clear view of what strong Part 11 compliance looks like in modern operations—and what to strengthen first to reduce risk while keeping processes efficient.

Areas Covered in the Webinar:

This webinar will cover the following key areas:

• Computer System Validation (CSV) and Software Assurance concepts (including CSA principles)
• System Development Life Cycle (SDLC) methodology (including common lifecycle approaches used today)
• Good Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Data Integrity (DI)
• Validation strategy, planning, and execution
• System risk assessment
• GAMP 5 lifecycle models (including the “V” model) and software categorization
• 21 CFR Part 11 and FDA guidance/expectations for Electronic Records/Electronic Signatures (ER/ES)
• Security, user access management, change control, and audit trails
• Key criteria/controls to ensure data is created, reviewed, and maintained with integrity throughout its lifecycle
• Policies and procedures to support validation/assurance and DI governance
• Training and organizational change management
• Current FDA trends in compliance focus and enforcement
• Industry best practices and common pitfalls

Why should you attend?

Part 11 issues rarely surface when a system is being implemented — they surface when it matters most: during an FDA inspection, a quality event, a data integrity concern, a system upgrade, or a vendor transition. In modern environments built on cloud/SaaS tools and connected platforms, teams often assume the vendor “handles compliance,” but FDA still expects the company to demonstrate control and governance over how records are created, protected, reviewed, and retained.

Many real-world gaps are surprisingly common: unclear “official record” in hybrid workflows, audit trails that are enabled but not meaningfully reviewed, electronic signatures that don’t clearly reflect intent (performed/reviewed/approved), weak role-based access and offboarding discipline, and change control that is either overly burdensome or not defensible. These are the kinds of hiccups that can quickly undermine the credibility of electronic records and signatures.

This webinar turns Part 11 into practical, inspection-ready actions—what strong ER/ES governance looks like, what evidence auditors expect to see, and how to avoid the pitfalls that trigger observations—so you can strengthen compliance while keeping operations efficient.

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to aid your teams in post-session implementation, such as:

• Part 11 Inspection-Ready Evidence Pack Builder (Toolkit)
• Audit Trail Review & E-Signature Governance Playbook (Toolkit)

Who will benefit?

This webinar is designed for professionals responsible for ensuring electronic records and electronic signatures are compliant, inspection-ready, and defensible across GxP systems—including cloud/SaaS and vendor-hosted platforms. It is especially valuable for teams who own validation/assurance, data integrity governance, system controls, and audit readiness—those include:

• Quality Assurance (QA) Manager
• Director of Quality Assurance
• Quality Systems Manager (QMS / eQMS)
• QA Compliance Manager / GxP Compliance Lead
• Computer System Validation (CSV) Manager
• CSV / CSA Lead
• Validation Engineer (CSV/CSA)
• Data Integrity Lead / Data Integrity Manager
• GxP IT Manager / IT Quality Manager
• IT Compliance Manager (GxP Systems)
• System Owner (GxP Systems)
• Application Owner (LIMS / MES / eQMS / ELN / ERP)
• Audit & Inspection Readiness Manager
• GxP Internal Auditor / Quality Auditor
• Supplier / Vendor Quality Manager (GxP software & SaaS)
• Information Security / IAM Lead supporting GxP systems
• Laboratory Systems Manager / LIMS Manager
• Manufacturing Systems Manager / MES Manager