TRUST CENTER
QUALITY WITH SECURITY, COMPLIANCE AND RELIABILITY
BLine Solution Pvt. Ltd. is a IT-OT deep-tech company headquartered in Indore, Madhya Pradesh – 562001, India, delivering industrial intelligence, automation software, integration, implementation, hardware and support solutions.
Our platforms were born in regulated industries, where accuracy and data integrity are requirements, not options. Every workflow, compliance control, and shop-floor operation in the BLine Suite and BLine Automation Suite 4.0 was designed from the start for complex, regulated environments, rather than adapted to them later.
Platform at a Glance
BLine System Core. Our core logic is written in C++ to keep processing close to the machine and reduce overhead. It supports GPU-accelerated processing for compute-intensive analytics and AI workloads.
The BLine Automation Suite connects production equipment through industrial protocols, IoT sensors, and a time series database that captures process data, so trends, anomalies, and deviations are visible in real time.
Regulatory Compliance:
- USFDA 21 CFR Part 11 and EU GMP Annex 11.
- Data integrity: ALCOA+++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
- Computer System Validation (CSV) and the GAMP 5 life-cycle approach.
- Good practice guidelines: GMP, GLP, GCP, GDP, and GSP.
- ISA-95 (IEC 62264) for information exchange between enterprise (IT) and (OT) systems.
- USFDA, EMA, MHRA, TGA, WHO-GMP, PIC/S, ICH, CDSCO (Schedule M), SFDA, MoHAP, and AIFA.
- Support customers across Europe, the Middle East, Africa, Asia-Pacific, and the Americas. Regional regulatory mapping is available on request.
Integrity
- Our systems are built so that logged data cannot be changed without detection.
- Original records are preserved and protected from overwriting or deletion.
- Authorized corrections are recorded as new, attributable, time-stamped entries with a reason for change, and the original value is retained.
- Audit trails are system-generated, secured against editing or disabling, and retained for the life of the record.
- There is no undocumented or shared administrative access to the data layer, including for BLine personnel.
- Direct database changes are prohibited outside formal change control and are logged and independently reviewed.
- Any suspected breach of record integrity is handled as a quality incident, with investigation, CAPA, and customer notification.
- Secure electronic signatures support approvals and authorizations.
- All data is encrypted in transit and at rest, with controlled key management.
- Responsibilities are defined under a shared-responsibility model.
- Cloud environments are qualified and hosting providers are assessed as part of our validation life-cycle.
- A list of sub-processors is available on request.
- Platform and processes are designed to support customer obligations under GDPR, UK GDPR, India’s Digital Personal Data Protection Act, and other applicable regional data protection laws.
- Clear information on how data is collected, used, and stored.
- AI outputs are traceable and logged in the audit trail.
Markets We Support
| Region | Countries | Privacy / Security Laws | Health Authorities & Guidelines |
|---|---|---|---|
| India | India | Digital Personal Data Protection (DPDP) Act 2023 | CDSCO, Revised Schedule M (GMP) |
| United States | United States | HIPAA | USFDA; 21 CFR Part 11 , 21 CFR Parts 210 and 211 (cGMP), FDA data integrity |
| EU, UK, Switzerland | Germany, France, Italy, Spain, Poland, Czechia, Hungary, Romania, Netherlands, Ireland, Denmark, United Kingdom, Switzerland | GDPR, UK GDPR, EU AI Act | EMA, MHRA, Swissmedic, AIFA, ANSM, AEMPS, HPRA, SÚKL; EU GMP Annex 11, PIC/S |
| Gulf & Middle East | Saudi Arabia, UAE (Dubai), Qatar, Jordan, Egypt, Turkey | PDPL and NCA, UAE PDPL, Qatar PDPPL, Egypt PDPL | SFDA, MoHAP / Emirates Drug Establishment, Qatar MoPH, JFDA, EDA, TITCK |
| Asia-Pacific | Australia, Singapore, Indonesia, Vietnam, South Korea, Bangladesh, Sri Lanka, Nepal, Myanmar | Australia Privacy Act, PDPA, | TGA, HSA, BPOM, DAV, MFDS, DGDA, NMRA, DDA |
| Africa | Nigeria, Kenya, South Africa, Ghana, Ethiopia, Tanzania | Nigeria NDPA, Personal data protection laws | NAFDAC, PPB, SAHPRA, Ghana FDA, EFDA, TMDA |
| Americas | Canada, Mexico, Peru | PIPEDA | Health Canada, COFEPRIS, DIGEMID |