Schedule M compliance, batch record management, regulatory submission integration, and multi-market release procedures
process manufacturing, quality inspection, yield management, and environmental compliance integration
multi-client batch separation, campaign management, and client-specific quality specifications
UDI compliance, device history records, lot traceability, and FDA 21 CFR Part 11 alignment
kit management, randomization integration, cold-chain logistics, and comparator supply tracking
food safety compliance, allergen management, and retail supply chain integration
Greenfield, brownfield, or selective data transition, with batch management, process orders, inspection lot management, and electronic batch records designed to your regulatory obligations from blueprint. GMP compliance is a design input, not a go-live checklist item. CSV scope, IQ/OQ/PQ protocols, 21 CFR Part 11 and Annex 11 alignment, and change control procedures are built into the program from the start.
DSCSA, EU FMD, and India’s serialization requirements each carry distinct data and integration demands. We implement end-to-end serialization on SAP, from packaging line integration through aggregation, regulatory reporting, and exception handling at the pharmacy or distributor level, across all markets your product reaches.
Deviation management, CAPA, change control, and out-of-specification handling built inside SAP QM, connected to your document management system and manufacturing execution layer. Clinical and commercial supply chains spanning CMOs, 3PLs operating under GDP, and market authorization holders connected on a single integration architecture, with audit trails your QA team and regulators can both stand behind.
Production order confirmation, batch record data, and quality results flowing from MES and LIMS into S/4HANA in real time. The LIMS integration that feeds inspection lots automatically. The MES connectivity that closes production orders without manual entry. Designed in before the blueprint is signed, not scoped as a follow-on workstream.
Batch statuses, quality holds, serialization exceptions, and regulatory submission timelines in one planning layer. We build on SAP Analytics Cloud and Datasphere to give manufacturing, supply chain, and finance a single operational picture, so supply decisions aren’t being made against data that’s three systems and a spreadsheet behind.
Regulatory changes, new market launches, and product lifecycle events all require controlled changes to a validated SAP environment. Candent’s 24x7 AMS practice operates under a change control framework, so your system stays compliant as the business changes around it. The same team that delivered the program maintains it.
ML models analyse charge composition, process parameters, and batch history to flag yield risk before a batch completes, reducing losses and investigation cycles.
AI-driven monitoring across manufacturing execution and quality systems identifies out-of-trend conditions earlier than manual review processes allow.
ML-assisted forecasting accounts for clinical trial variability, product lifecycle position, and distribution channel behaviour to improve supply accuracy.
ML models assist in compiling and reviewing submission packages, flagging gaps before audits and reducing manual preparation time.
IoT-connected asset data feeds ML models that schedule maintenance before a breakdown disrupts a validated production line.
GMP, CSV, and serialization requirements scoped at assessment and carried through the blueprint. Built to be validated.
LIMS, MES, serialization, and QMS touchpoints mapped and sized as part of the program design.
Programs led by practitioners with direct pharma SAP experience.
The same team that built the solution manages changes under a framework your QA team can defend in an audit.
Every consultant comes through Candent Academy’s SAP training pipeline. Onboarding happens on our time, not yours.
