IT AS A SERVICES (Pharmaceutical, Healthcare and Related Industries)
BLINE SOLUTION PRIVATE LIMITED
we are dedicated to transforming pharmaceutical manufacturing through innovative technology solutions. Recognizing the complexities and stringent regulatory demands of the industry, we have developed a cutting-edge platform designed to streamline workflows, enhance operational efficiency, and ensure full compliance with global standards.
Our Purpose
Many large software companies and their solutions often have overly complex workflows, making them very difficult for end-users to navigate. Creating a complete process for even a single function frequently involves numerous forms and hierarchical layers. While the software might initially appear feature-rich, its practical implementation and use often reveal many gaps, issues, and unnecessary functionalities that consume a lot of time. Furthermore, directly linking these complex forms to AI, IoT, or external systems proves to be very complicated and confusing.
In the pharma manufacturing industry, which has even more intricate workflows and strict guidelines, we’ve conducted in-depth research and analysis to develop a unique platform. This platform offers a simple and easy flow, managing detailed processes and operations within a single unified system. It eliminates unnecessary complexities, bridges critical gaps, and adheres to all relevant guidelines. Keeping these issues in mind, my primary objective in designing this platform was to ensure it has a significantly low operating cost, strictly follows all pharma industry guidelines, and is easy to operate.
(Note: We are not only working in Pharma; we also work across all industry types to manage detailed and complex processes in a simple manner.)
Our commitment to providing software and hardware solution that complies with global standards
GxP: Good Practices (Industry Standards): The system and its processes will comply with relevant GxP guidelines, including:
GMP – Good Manufacturing Practice
GLP – Good Laboratory Practice
GCP – Good Clinical Practice
GDP – Good Distribution Practice
GAP – Good Agricultural Practice
GSP – Good Storage Practice
Compliance with Global Regulatory Authorities
USFDA – United States Food and Drug Administration (21 CFR Part 11)
EMA – European Medicines Agency
TGA – Therapeutic Goods Administration (Australia)
MHRA – Medicines and Healthcare Products Regulatory Agency (UK)
FDA (Italy) – Agenzia Italiana del Farmaco (AIFA)
WHO – World Health Organization
PIC/S – Pharmaceutical Inspection Co-operation Scheme
Data Protection & Privacy Compliance
GDPR – General Data Protection Regulation (EU)
HIPAA – Health Insurance Portability and Accountability Act (USA)
Validation and Data Integrity Standards:
CSV – Computer System Validation: As per GAMP 5 risk-based approach.
GAMP 5 – Good Automated Manufacturing Practice: Guidelines for validating automated systems.
ICH Q7/Q9/Q10 – International Council for Harmonisation: Covers quality systems, risk management, and GMP for APIs.
EU GMP Annex 11 – European guidelines for computerized systems in GMP environments.
WHO TRS 996 – WHO Technical Report Series covering computer systems and validation in health product manufacturing.
Our Mission
To empower pharmaceutical manufacturers with an intuitive, unified platform that simplifies complex processes, eliminates inefficiencies, and guarantees adherence to regulatory guidelines—ensuring safer, faster, and more reliable drug production.
Our Vision
To become the leading Technology partner for pharmaceutical manufacturing, driving the future of smart, compliant, and agile production through intelligent automation and seamless workflow integration.
(Santosh Agrawal – MCA, B.Sc (Computer Science + Statistics), Oracle Certified – Managing Director)
The secret to our success? An intense focus on understanding our customer needs. We deeply understand your business processes, identify optimization potential, and develop specifications that help you realize that potential.