Pharma: compliance, traceability and digitalization

Pharmaceutical manufacturers must balance innovation with strict regulatory requirements and end-to-end traceability. We help you digitalize your processes, strengthen compliance and enhance patient safety.

  • Process digitalization
  • Regulatory compliance
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Challenges

Key challenges in the pharmaceutical industry

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Securing supply continuity

Ensuring product availability requires tighter coordination between demand forecasting, inventory levels and production capacity. Guaranteeing patient access me...

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Accelerating access to generics and biosimilars

Shortening time-to-market for alternative therapies demands smoother processes between R&D, regulatory, manufacturing and distribution. Optimized developmen...

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Embedding sustainability across the value chain

Reducing environmental impact - from eco-design to waste management and raw-material transparency - requires integrating s...

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Addressing antimicrobial resistance (AMR)

Strengthening traceability, control and data-sharing is essential to mitigate AMR-related risks. This means improved tracking ...

hrc-consulting-icon-secure

Securing supply continuity

Ensuring product availability requires tighter coordination between demand forecasting, inventory levels and production capacity. Guaranteeing patient access means improving reliability, responsiveness and transparency across the entire pharmaceutical supply chain.

hrc-consulting-icon-speed

Accelerating access to generics and biosimilars

Shortening time-to-market for alternative therapies demands smoother processes between R&D, regulatory, manufacturing and distribution. Optimized development workflows and consolidated product data help anticipate critical milestones and align decision-making.

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Embedding sustainability across the value chain

Reducing environmental impact - from eco-design to waste management and raw-material transparency - requires integrating sustainability criteria early in product design and throughout the full lifecycle.

 

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Addressing antimicrobial resistance (AMR)

Strengthening traceability, control and data-sharing is essential to mitigate AMR-related risks. This means improved tracking of sensitive substances, better coordination between production and distribution, and robust monitoring and reporting mechanisms across the healthcare ecosystem.

Why choose HRC Consulting

Our expertise for the pharmaceutical industry

We combine SAP expertise, deep industry knowledge and regulatory rigor to support your transformations, from R&D to distribution, ensuring full traceability, quality and compliance at every step.

Our teams work across the full pharmaceutical value chain: R&D, quality, supply chain, manufacturing, regulatory affairs and distribution.
This 360° perspective allows us to propose coherent, targeted solutions that align operational constraints with regulatory expectations and business priorities.

We work hand-in-hand with your teams to design pragmatic and field-ready solutions.
Workshops, rapid prototyping and iterative validation ensure that each process, screen or flow is directly usable by operators, QC analysts, supply planners or QA reviewers — not just compliant on paper.

We help you secure your data foundations: reliable master data, controlled flows, consistent batch traceability and solid documentation chains.
This enables end-to-end visibility, auditability and seamless integration across manufacturing, quality and distribution processes.

We handle mission-critical contexts with discipline and adaptability: compliance remediation, IS redesigns, validation-heavy environments, regulatory audits, serialization, cold-chain constraints or changes driven by EMA/FDA expectations.
Our teams are familiar with GxP requirements, validation cycles and change-control governance.

We focus on delivering concrete, durable results: improved batch release timelines, reduced deviations, strengthened traceability, better audit readiness, smoother inspections and more reliable operations.
Each project is aligned with your strategic ambitions: product availability, patient safety, operational excellence and regulatory compliance.

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Solutions

SAP solutions for the pharmaceutical industry

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SAP S/4HANA

Unifies R&D, manufacturing, quality and distribution within a single integrated system, ensuring data integrity, process consistency and regulatory compliance across the entire value chain.

 

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HRC Software

Ready-to-use SAP mobile applications that accelerate digitalization in warehouse operations, procurement and industrial maintenance, fully aligned with GxP and operational field requirements.

 

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SAP EWM

Manages sensitive and regulated inventories with precise lot tracking, expiry date control and strict storage rules tailored to pharmaceutical environments.

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SAP BTP

Enables the development of GxP-compliant business applications with low-code/no-code agility, integrated validation workflows and secure SAP-native connectivity.

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SAP QM

Supports inspections, analytical results and CAPA processes to maintain continuous, audit-ready quality control that meets stringent pharmaceutical standards.

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SAP ATTP

Ensures serialization, authentication and end-to-end traceability of individual drug units in line with global compliance requirements (EU FMD, DSCSA, etc.).

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SAP Analytics Cloud

Consolidates manufacturing, quality and supply chain KPIs to anticipate risks, strengthen visibility and simplify regulatory and operational reporting.

Contact us

Accelerate your pharmaceutical transformation projects

  • End-to-end, unit-level traceability
  • Full GxP compliance
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