Pharma Industry
In pharma, compliance is the licence to operate. If SAP can’t guarantee traceability, data integrity and validation, the risk isn’t downtime. It’s regulatory action.
Your SAP landscape needs to support GxP, protect patient data and stay rock-solid under inspection.
That’s where 1DigitalTrust comes in.
INDUSTRY CHALLENGE
Don’t let a Messy SAP Setup Make Your Production Sick.
Regulators expect full visibility, faster audits and credible digital traceability. Requirements like GxP, 21 CFR Part 11, EU Annex 11, DSCSA and EU FMD all need to live cleanly inside SAP. When they don’t, compliance slips, revalidation costs rise and release cycles stall.
And compliance is only part of the pressure. Fragmented roles, weak access controls and unmonitored integrations open the door to audit findings and IP leakage. Data integrity issues delay batch release, block approvals or send quality teams into crisis mode.
Pharma can’t afford that kind of instability. SAP needs to behave like validated infrastructure, not a loose collection of roles and workflows.
Selected Pharma Clients
SERVICES THAT FIT THE INDUSTRY
Why Pharma Producers Choose 1DigitalTrust
Aligned
Validation-Ready Architecture
Access is designed around core pharma processes, from QA and QC to batch release, regulatory reporting and plant operations. Roles reflect real job functions and enforce SoD from day one. You get clean, auditable access that stays stable through inspections, audits and team changes.
Access
Pharma-Ready Role Design
SAP processes and controls align with GxP, 21 CFR Part 11 and Annex 11. Quality, production and lab activity becomes traceable, reviewable and defensible. Data integrity, audit trails and approval steps live inside the system, not in manual workarounds.
Compliance
Automated GRC Controls
Controls, Firefighter access, audit logging and risk alerts operate inside SAP, not in spreadsheets.
Spend
License Optimisation
License types reflect actual system usage, not job titles or hypothetical access. Overspend drops, FUE assignments make sense and validated environments stay clean and compliant without triggering unnecessary revalidation work.
Migration
S/4-Ready Access Model
Roles, code and access controls are prepared before the move so migration doesn’t break compliance or force unnecessary revalidation.
Safety
SAP Cybersecurity Monitoring
Continuous monitoring highlights vulnerabilities, misconfigurations and risky roles before they threaten IP or patient data.
Retail focus
What we deliver
Your SAP setup shouldn’t be the thing that slows you down when audits land or S/4 planning starts.
You can get a system that is:
Validation-ready design and documentation
License cost reductions of 20–40 %
Embedded GxP controls across SAP
Clean SoD and reliable audit logging
Continuous protection for IP and patient data
S/4 migrations that move without revalidation chaos
STATS
Trust the Numbers
20-40%
80%+
95–97%
70-80%
90%+
WHY 1DIGITALTRUST
Expertise knowledge is the key.
– Deep experience across EU and US regulatory frameworks
– Access and security that support validation, not complicate it
– License governance based on real usage
– Expertise in batch traceability, serialization and supply chain controls
– S/4 readiness designed to avoid revalidation cycles
– Ongoing monitoring so controls stay effective after go-live
Customer case
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