Automation & Control Systems (GxP)

GxP automation and control systems (DCS, PLC/SCADA, Building Management, and recipe management) run the process and create the electronic record of what happened. In regulated manufacturing, design, configuration, and changes must support data integrity, access control, and a validated state. Poorly controlled automation becomes both an operational risk and a 21 CFR Part 11 / EU Annex 11 finding waiting to happen, especially when recipes, historian tags, and electronic batch records drift from the validated configuration.

Viltis helps engineering and CSV teams align control system architecture with process needs and quality expectations. We support URS development, configuration review, interface mapping, alarm strategy, and change control for automation updates. Work often sits at the boundary of automation engineering and computer system validation: recipe management, historian configuration, EBR and MES interfaces, and vendor patches that must stay under governance after go-live. We push for designs operators can run without workarounds that create uncontrolled local practice.

Alarm floods, poorly designed interlocks, and uncontrolled local recipes are operational problems with compliance consequences. We review how operators actually interact with the system, not only how the functional specification reads. Where workarounds exist, we help either eliminate the need for them or bring them under change control and training so the electronic record matches reality. Vendor remote access, patch windows, and disaster recovery expectations are reviewed as part of ongoing GxP control.

Automation and control support typically covers

• Control system URS and design review
• PLC, SCADA, and BMS configuration oversight
• Alarm management and operator interface review
• Data integrity and access control checks
• CSV-aligned testing and documentation support
• Automation change control and patch governance
• Integration with EBR, MES, and historians

Automation should make the process steadier, not harder to explain. We help sites keep control systems maintainable, auditable, and matched to how operators actually run batches so validation evidence still matches the live configuration years after start-up. When upgrades are unavoidable, we help sequence validation and cutover so production is not trapped between an obsolete system and an unfinished one. If a control system upgrade or MES cutover is on the calendar, we help sequence validation, training, and fallback plans so go-live is controlled.