Pharma, medical device and specialty manufacturers bring us in when their SAP system has to stand up to inspection. We're a Philadelphia boutique of fewer than fifty people, and for nine years we've treated ERP in a regulated plant as part of the quality system, not a separate IT project.
We implement S/4HANA for established manufacturers and SAP Business ByDesign for smaller and emerging life-sciences companies. SAP Quality Management handles inspection lots, usage decisions, certificates of analysis and nonconformances, and we design batch and serial traceability from the first workshop. A recall or an inspector's question should never depend on rebuilding genealogy from spreadsheets.
Validation runs alongside the build, not after it. We follow a risk-based approach aligned with GAMP 5 and write user requirements, risk assessments, test scripts and traceability matrices as configuration progresses, so your QA team reviews deliverables while decisions are still fresh. Every setting has a documented rationale, and we apply the same discipline to electronic records and signatures under 21 CFR Part 11 and EU GMP Annex 11. Because we're small by design, the consultants who scope your project are the same people who write your test scripts and sit with your QA reviewers.