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.