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Compliance

EnvisionSCADA and 21 CFR Part 11

How EnvisionSCADA supports electronic records, audit trails, user accountability, and validation activities in regulated environments.

Designed to Support 21 CFR Part 11 Compliance

In regulated industries such as pharmaceuticals, biotechnology, life sciences, and medical devices, electronic records and electronic signatures must meet stringent regulatory requirements. The United States Food and Drug Administration (FDA) established 21 CFR Part 11 to define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

Omnicon Automation, in cooperation with SunForest BV, is committed to ensuring that EnvisionSCADA provides the technical capabilities required to support organizations pursuing compliance with 21 CFR Part 11 and related regulations, including EU GMP Annex 11 and GAMP® 5.

Because regulatory compliance depends on system configuration, validation activities, procedures, and operational controls, EnvisionSCADA should be considered a platform designed to support compliance rather than a standalone compliance solution.

Electronic Records

EnvisionSCADA provides capabilities that support the management and retention of electronic records, including:

  • Historian data collection and storage
  • Alarm and event recording
  • Audit trail generation
  • Configuration management records
  • Batch and process data recording
  • User activity logging
  • Time-stamped system events

These records can be retained, reviewed, and exported according to organizational requirements and applicable validation procedures.

Audit Trails

A fundamental requirement of 21 CFR Part 11 is the ability to maintain secure, computer-generated, time-stamped audit trails.

EnvisionSCADA includes audit trail functionality that can record:

  • User logins and logouts
  • Configuration changes
  • Object modifications
  • Alarm acknowledgements
  • Recipe modifications
  • Administrative actions
  • System events and operational activities

Audit records are designed to provide traceability and accountability throughout the system lifecycle.

User Access Control

Part 11 requires that system access be limited to authorized individuals.

EnvisionSCADA supports:

  • Individual user accounts
  • Role-based access control (RBAC)
  • Permission-based security
  • Password management policies
  • Authentication mechanisms
  • Session management controls

These features help organizations implement appropriate security procedures and access controls.

Electronic Signatures

For organizations requiring electronic signature functionality, EnvisionSCADA provides mechanisms that can support:

  • User authentication prior to signing
  • Signature attribution to individual users
  • Time-stamped signature records
  • Association of signatures with electronic records
  • Reason-for-signature workflows where applicable

Implementation and validation of electronic signature procedures remain the responsibility of the regulated organization.

Record Integrity

Maintaining the integrity of regulated data is a key requirement of Part 11.

EnvisionSCADA includes features designed to support data integrity principles, including:

  • Controlled access to records
  • Audit trail protection
  • Time-stamped records
  • Change tracking
  • Backup and recovery capabilities
  • High-availability deployment options
  • Database integrity controls

These capabilities help organizations support ALCOA+ principles for data integrity, including ensuring that records are attributable, legible, contemporaneous, original, and accurate.

System Validation Support

21 CFR Part 11 requires that systems be validated for their intended use.

EnvisionSCADA is designed to support computerized system validation (CSV) activities through:

  • Version-controlled releases
  • Change management processes
  • Installation documentation
  • Test documentation support
  • Traceability capabilities
  • Configuration management controls

Validation activities, including IQ, OQ, PQ, and risk assessments, remain the responsibility of the system owner and regulated organization.

Security and Availability

Reliable operation and protection of regulated records are essential components of a compliant environment.

EnvisionSCADA supports:

  • Secure communications through HTTPS/TLS
  • Redundant server architectures
  • Backup and disaster recovery strategies
  • Network segmentation practices
  • Role-based security controls
  • High-availability deployment options

These capabilities help organizations maintain the availability and security of regulated data.

Alignment with Industry Standards

EnvisionSCADA is frequently deployed in environments operating under:

  • FDA 21 CFR Part 11
  • EU GMP Annex 11
  • GAMP® 5
  • ISPE Good Practice Guides
  • Pharmaceutical Computerized System Validation (CSV) frameworks

The platform has been designed with these regulatory expectations in mind while maintaining flexibility for a wide range of industrial and life sciences applications.

Our Commitment

Regulatory compliance is achieved through a combination of technology, procedures, validation, and operational controls.

Omnicon Automation, together with SunForest BV, is committed to:

  • Continuous product improvement
  • Long-term platform support
  • Secure software development practices
  • Robust auditability and traceability features
  • Support for regulated industry requirements
  • Ongoing alignment with industry best practices and regulatory expectations

By providing the technical foundation necessary for secure electronic records, audit trails, user accountability, and system validation, EnvisionSCADA helps organizations build and maintain compliant computerized systems within regulated environments.

For more information about EnvisionSCADA's validation and compliance-support features, please contact Omnicon Automation.