⭐ PHARMA DOCUMENTATION (QA • ENGINEERING • CSV)
Compliance-Driven Documentation for Regulatory-Ready Pharmaceutical & API Facilities
Adhyntra Pvt Ltd provides complete Pharmaceutical Documentation services covering QA systems, Engineering documentation, and Computer System Validation (CSV). Our documentation is structured to meet US-FDA, EU-GMP, WHO-GMP, and data integrity (ALCOA+) expectations, ensuring your facility is fully audit-ready and compliant.
With strong experience in real plant operations, engineering, and automation, we develop practical, accurate, and standardized documents that support smooth manufacturing, safe operations, and transparent regulatory compliance.
⭐ QA Documentation
-
SOPs, work instructions, and GMP policies
-
Change Control, Deviation & CAPA documentation
-
Master Validation Documents: URS, DQ, IQ, OQ, PQ
-
Batch manufacturing records & logbooks
-
GMP compliance templates aligned with US-FDA, EU-GMP & WHO
⭐ Engineering Documentation
-
P&ID, Equipment List, Line List & Utility Layouts
-
Preventive Maintenance SOPs & calibration records
-
Equipment qualification files (URS, DQ, IQ/OQ)
-
As-built drawings and engineering change records
-
Utility validation documentation (HVAC, water, clean utilities)
⭐ Computer System Validation (CSV)
-
URS, SDS, Risk Assessments & Data Integrity Assessments
-
IQ/OQ/PQ protocols for PLC, SCADA, BMS & automation systems
-
21 CFR Part 11 compliance documentation
-
Access control matrices & audit trail review procedures
-
FAT/SAT documentation & system lifecycle files
⭐ Why Choose Us
- Fully GMP, ALCOA+ and regulatory compliant documentation
- Audit-friendly, structured, and industry-standard format
- Covers QA + Engineering + CSV under one roof
- Strong domain expertise in API, Pharma & Automated Systems
- Fast turnaround and easy-to-implement templates
We provide complete Pharma Documentation covering QA, Engineering, and CSV—SOPs, validation files, P&IDs, maintenance records, and 21 CFR Part 11–compliant automation documents. All templates are GMP, US-FDA, EU-GMP, and ALCOA+ aligned, ensuring your plant is fully audit-ready and regulatory compliant.
