Client's Testimonial

"For us, SAP support is all about trust and discipline. We can't afford mistakes. The CMMI Level 5 and SOC 2 certifications from Developers.dev were the initial draw, but it's the meticulous execution and documentation from their team that has been truly impressive. Our last FDA audit of the SAP system was the smoothest we've ever had."

Maria Garcia, Head of Quality & Compliance

Client Overview

A $900 million medical device manufacturer subject to stringent regulatory oversight from the FDA and other international bodies. Their SAP ECC system manages validated, GxP-compliant processes for manufacturing, quality management, and distribution. Data integrity and system security are not just business requirements; they are legal mandates.

Problem

The client was struggling with their previous support vendor, who lacked the process discipline required for a validated environment. Change control was poor, documentation was inconsistent, and they were constantly finding themselves unprepared for audits. They needed a partner who understood the unique demands of a regulated industry.

Key Challenges

Audit & Compliance Risk:

Their existing support processes were creating a significant risk of failing regulatory audits.

Poor Change Management:

Changes were being moved to production without proper testing or documentation, threatening system validation.

Inadequate Security Controls:

User access reviews were infrequent, and security configurations were not being monitored for vulnerabilities.

Lack of GxP Knowledge:

The previous vendor did not understand the principles of Good Manufacturing Practice (GMP) and how they applied to an ERP system.

Our Solution

Developers.dev was selected based on our verifiable process maturity. We implemented our "Compliance & Support POD," a specialized managed service designed for regulated industries.

⚙️ CMMI-5 Driven Processes

We replaced their ad-hoc processes with our audited, CMMI Level 5-compliant workflows for incident, problem, and change management.

✅ Validated Change Control (ChaRM)

We implemented and enforced a strict change management process using SAP Solution Manager (ChaRM), ensuring every change was properly requested, tested, approved, and documented.

🛡️ Continuous Security Monitoring

We deployed security monitoring tools and established a quarterly user access review process to ensure a state of continuous compliance.

🧑‍🎓 GxP-Trained Team

The assigned support POD received specific training on the client's GxP requirements and validation protocols.

Implementation and Execution

Initial Audit

We began with a full audit of their existing SAP security and change management processes.

Gap Analysis & Remediation

A gap analysis report was presented to the client with a clear remediation plan.

ChaRM Configuration & Training

SAP ChaRM was configured and rolled out with training for the client's key users.

System Security Plan

A comprehensive System Security Plan (SSP) document was created for their SAP landscape.

Validated Ticketing

All support activities were logged in a validated ticketing system with detailed, audit-ready records.

QA Collaboration

Our team worked directly with the client's Quality Assurance department to ensure all processes met their validation standards.

Positive Outcome

✅ Successful FDA Audit

The client passed their next FDA system audit with no major findings related to the SAP environment.

📉 95% Reduction in Unauthorized Changes

Our strict ChaRM process virtually eliminated unauthorized or undocumented changes to the production system.

📝 Audit-Ready Documentation

All support and change activities were meticulously documented, reducing audit preparation time from weeks to days.

🔒 Improved Security Posture

Proactive monitoring and regular access reviews significantly hardened their system against both internal and external threats.

Why Choose Us

👥 POD Model

Provided the exact talent mix they needed, flexibly.

🤖 AI-Augmented Delivery

AI tools were used to monitor for security configuration drift.

✅ Verifiable Process Maturity

Our CMMI 5, SOC 2, and ISO 27001 certifications were the core reason we were chosen.

🔐 Guaranteed IP Protection

All compliance documentation and process improvements were owned by the client.

🌍 Deep USA & EMEA Focus

We have extensive experience with FDA and EMA (European Medicines Agency) regulations.

💡 Radical Transparency

The client's QA team had full read-only access to our ticketing and change management systems.

🌟 Full-Spectrum Expertise

We provided a blend of Basis, Security, and GxP process expertise.

🛡️ Zero-Risk Talent

Our team's discipline and expertise were evident throughout the paid trial period.

📈 A Focus on Your ROI

Our ROI was measured in risk reduction and the avoidance of costly audit failures and fines.

Conclusion

For this life sciences client, the value of SAP support was measured by discipline, security, and compliance. Developers.dev's proven, audited processes provided the exact solution they needed, transforming their SAP support from a major compliance risk into a model of control and audit-readiness.

Life Sciences Firm Achieves Audit-Ready SAP Compliance and Security with a CMMI-5 Certified Partner

Industry Medical Devices / Life Sciences