Pharmaceutical & Life Sciences
The pharmaceutical and life sciences industry operates in one of the most highly regulated and complex environments, where compliance, patient safety, and operational efficiency are critical. Companies in this sector must adhere to strict global standards such as FDA 21 CFR Part 11, GxP, EMA guidelines, DSCSA, and Good Manufacturing Practice (GMP), while ensuring full traceability, data integrity, and rigorous quality management across the value chain.
To meet these demands, pharmaceutical organizations rely on advanced enterprise solutions that support batch management, serialization, recipe management, audit trails, and regulatory reporting, as well as robust EDI integrations that enable secure, accurate, and traceable data exchange with suppliers, distributors, and healthcare partners.
By leveraging technologies such as ERP, predictive analytics, and process automation, the industry is enhancing visibility across the supply chain, accelerating time-to-market, reducing operational costs, and ensuring readiness for inspections and audits.
From large pharmaceutical manufacturers to biotechnology firms, CMOs, and distributors, success increasingly depends on the ability to integrate compliance-driven systems with innovation, ensuring not only regulatory adherence but also improved patient outcomes and long-term competitiveness.
Pharmaceutical & Life Sciences Challenges and How GETR Assists
Operating in one of the world’s most highly regulated sectors, pharma and life sciences companies face stringent compliance, traceability, and quality demands. The table below highlights these challenges and how GETR’s SAP and EDI expertise ensures compliance, efficiency, and innovation.
Regulatory Compliance (FDA, EMA, GxP, GMP)
Batch & Lot Traceability
Serialization & Anti-Counterfeit
Quality & Validation Processes
Cold Chain & Special Handling
Formulation & Recipe Management
Clinical Trial Supply Management
Supply Chain & Global Distribution
Data Integrity & Auditability
Analytics & Regulatory Reporting
Unique Requirements and Challenges
Strict adherence to FDA 21 CFR Part 11, EMA Annex 11, GxP, and GMP is required. SAP standard often lacks fully validated processes.
How GETR Assists
Implement validated SAP environments with audit trails, electronic signatures, and GxP-compliant workflows. Provide CSV (Computer System Validation) and SOP alignment.
Implement validated SAP environments with audit trails, electronic signatures, and GxP-compliant workflows. Provide CSV (Computer System Validation) and SOP alignment.
Unique Requirements and Challenges
Pharma requires end-to-end traceability of raw materials, intermediates, and finished drugs. Gaps can lead to recalls or compliance violations.
How GETR Assists
Configure SAP batch management with serialization and track-and-trace. Integrate SAP ATTP (Advanced Track and Trace for Pharmaceuticals) for end-to-end visibility.
Configure SAP batch management with serialization and track-and-trace. Integrate SAP ATTP (Advanced Track and Trace for Pharmaceuticals) for end-to-end visibility.
Unique Requirements and Challenges
Global regulations (DSCSA in US, FMD in EU, ANVISA in Brazil, etc.) mandate serialization to fight counterfeiting.
How GETR Assists
Deploy SAP ATTP and ICH-compliant solutions to manage serialization, aggregation, and reporting to regulatory hubs.
Deploy SAP ATTP and ICH-compliant solutions to manage serialization, aggregation, and reporting to regulatory hubs.
Unique Requirements and Challenges
In-process quality checks, batch release, and deviation management are often manual or disconnected from ERP.
How GETR Assists
Implement SAP QM integrated with production and procurement. Automate COA, deviation workflows, and batch release processes.
Implement SAP QM integrated with production and procurement. Automate COA, deviation workflows, and batch release processes.
Unique Requirements and Challenges
Pharma products require strict temperature monitoring during storage and transport.
How GETR Assists
Configure SAP EWM with temperature zones and IoT integrations. Enable FEFO and real-time cold chain monitoring via barcode/RFID.
Configure SAP EWM with temperature zones and IoT integrations. Enable FEFO and real-time cold chain monitoring via barcode/RFID.
Unique Requirements and Challenges
Complex formulas, potency variations, and scaling are difficult to manage in SAP standard PP.
How GETR Assists
Optimize PP-PI recipes and production versions. Implement SAP PP-PI extensions for formula management with active ingredient calculations.
Optimize PP-PI recipes and production versions. Implement SAP PP-PI extensions for formula management with active ingredient calculations.
Unique Requirements and Challenges
Trial material distribution must be tracked globally with compliance.
How GETR Assists
Configure SAP for clinical supply chain visibility. Integrate with trial management systems for demand planning, labeling, and returns.
Configure SAP for clinical supply chain visibility. Integrate with trial management systems for demand planning, labeling, and returns.
Unique Requirements and Challenges
Highly regulated international shipments face delays due to poor SAP–logistics integration.
How GETR Assists
Enable SAP GTS (Global Trade Services) for export/import compliance. Integrate logistics partners for seamless global distribution.
Enable SAP GTS (Global Trade Services) for export/import compliance. Integrate logistics partners for seamless global distribution.
Unique Requirements and Challenges
Pharma requires validated data systems with audit-ready logs.
How GETR Assists
Ensure data integrity with SAP audit trails, role-based access, and validation documentation. Provide periodic compliance reporting.
Ensure data integrity with SAP audit trails, role-based access, and validation documentation. Provide periodic compliance reporting.
Unique Requirements and Challenges
Executives and regulators demand insights into quality, compliance, and product safety.
How GETR Assists
Build SAP BW/4HANA, Datasphere, or Power BI dashboards for compliance KPIs, batch genealogy, and global safety monitoring.
Build SAP BW/4HANA, Datasphere, or Power BI dashboards for compliance KPIs, batch genealogy, and global safety monitoring.
Why Pharmaceutical & Life Sciences partner with GETR:
Deep experience in regulated industries with SAP PP-PI, QM, EWM, and ATTP.
Expertise in compliance-driven ERP implementations (21 CFR Part 11, GMP, GxP).
Fractional FTE AMS support for cost-effective ongoing operations.
Proven track record in serialization, traceability, and cold chain integration.
Global delivery centers in the U.S., Mexico, and India with 24×7 coverage.