What are Digital Pharma Integration Services?

Our services provide end-to-end digital transformation, including SCADA and IoT integration, eBMR/eBPR implementation, serialization for track-and-trace, and 21 CFR Part 11 compliance, ensuring GMP-aligned operations.

Why is it Critical?

Digital transformation enhances operational efficiency, ensures data integrity, and improves supply chain transparency, meeting regulatory requirements and enabling audit-ready pharmaceutical operations.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led digital solutions, guiding manufacturers to implement compliant, scalable, and innovative systems for global market readiness.

Our Expert Digital Transformation Approach

At Indivirtus Healthcare Services, our Digital Pharma Integration services are led by certified experts specializing in pharmaceutical digitization. We design and implement SCADA and IoT systems for real-time monitoring, deploy eBMR/eBPR for paperless operations, and establish serialization systems for supply chain compliance. Our team ensures 21 CFR Part 11 compliance through robust data integrity practices.

Our tailored approach includes comprehensive assessments and strategic implementation plans, delivering scalable and audit-ready solutions that align with global regulatory standards and enhance operational efficiency.

Digital Pharma Integration Deliverables

Digital Integration Assessment Report: Detailed analysis of digital transformation needs and gaps.

SCADA/IoT System Architecture: Framework for real-time monitoring and control systems.

eBMR/eBPR Implementation Plan: Roadmap for paperless batch record systems.

Serialization Compliance Framework: Tools for track-and-trace and supply chain transparency.

21 CFR Part 11 Audit Checklist: Comprehensive guide for data integrity compliance.

Regulatory Compliance & Global Standards

Our Digital Pharma Integration services align with stringent global standards, ensuring your digital systems are audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance data integrity and regulatory confidence.

  • 21 CFR Part 11: U.S. regulations for electronic records and signatures.
  • EU GMP Annex 11: European guidelines for computerized systems in GMP environments.
  • PIC/S Guidelines: Global standards for GMP-compliant digital systems.
  • GS1 Standards for Serialization: Guidelines for supply chain track-and-trace systems.
  • ICH Q10: Pharmaceutical Quality System framework for digital integration.

Applications & Use Cases

Our Digital Pharma Integration services are essential for pharmaceutical manufacturers seeking to modernize operations and ensure GMP compliance. Ideal for implementing real-time monitoring, paperless systems, or serialization, our solutions support regulatory audits and supply chain transparency. Key use cases include deploying SCADA/IoT for manufacturing, transitioning to eBMR/eBPR, and ensuring compliance for global market distribution.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led digital transformation solutions backed by certified professionals with global regulatory experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your facility with innovative, compliant, and scalable digital systems, driving regulatory success and operational excellence.

Frequently Asked Questions

Frequently Asked Questions

What is SCADA and IoT integration in a pharmaceutical setting?

SCADA and IoT allow for automated, real-time monitoring and control of equipment, utilities, and production parameters, improving GMP efficiency and data availability.

How do eBMR/eBPR systems improve pharmaceutical manufacturing?

eBMR and eBPR systems digitize batch and packaging records, reduce errors, streamline approvals, and provide instant compliance documentation for audits and reviews.

What are pharma track & trace systems used for?

Track & trace systems ensure product serialization and supply chain transparency, protecting against counterfeiting and complying with regulations like US DSCSA and EU FMD.

What does 21 CFR Part 11 compliance entail?

It requires systems handling electronic records/signatures to have validated controls, secure audit trails, restricted access, and documented SOPs per FDA guidelines.

How long does a digital integration project typically take?

Digital transformation projects generally take 6–8 weeks depending on facility complexity, system maturity, and whether integrations are local or cloud-based.

What do Digital Pharma Integration services include?

Our services include SCADA and IoT integration, eBMR/eBPR implementation, serialization for track-and-trace, and 21 CFR Part 11 compliance, ensuring GMP-aligned digital transformation.

Who benefits from Digital Pharma Integration services?

Pharmaceutical manufacturers modernizing operations, seeking real-time monitoring, paperless systems, or supply chain transparency benefit from our tailored digital solutions.

How do these services ensure regulatory compliance?

Our services align with 21 CFR Part 11, EU GMP Annex 11, PIC/S Guidelines, GS1 Standards, and ICH Q10, ensuring digital systems are audit-ready and compliant with global standards.

What deliverables are provided with the service?

Clients receive a digital integration assessment report, SCADA/IoT system architecture, eBMR/eBPR implementation plan, serialization compliance framework, and a 21 CFR Part 11 audit checklist.

Can the digital transformation services be customized for our needs?

Yes, our services are tailored to your facility’s specific operational and regulatory requirements, ensuring practical and compliant digital solutions.

How do the services support serialization and data integrity?

We deploy serialization frameworks for track-and-trace compliance and ensure 21 CFR Part 11 compliance through robust data integrity practices, supporting audit-ready operations.