End-to-end validation, design &
GxP software.
Concept-to-operation services for Pharma, Biotech and Life Sciences — engineered for regulatory excellence.
Eight phases. One trusted partner.
01
Preparation
02
Design
03
Pre-Construction
04
Construction
04
Commissioning
05
Pre-Handover
06
Initial Occupation
08
Aftercare
SERVICE / 01
Computer System
Validation
GAMP 5 lifecycle validation for legacy upgrades, automation, PLC/SCADA, EMS/BMS, application software and Excel sheets — fully aligned with EU Annex 11 and 21 CFR Part 11.
- Upgradation of Legacy Systems
- PLC and SCADA Validation (GAMP)
- EMS / BMS Qualification
- Audit Trail Review Assessments
- ERES Assessments
- Automation Support
- Application Software Validation (Annex 11 / 21 CFR Part 11)
- Excel Sheet Validation
- Periodic Review Assessments
- GAP Assessments — All Computerised Systems
SERVICE / 02
Commissioning &
Qualification
End-to-end CQV for greenfield and brownfield pharmaceutical projects — preparation, design, pre-construction, construction, commissioning, handover and post-occupancy aftercare.
- Process Engineering
- Commissioning & Qualification
- Facility, Black & Clean Utility, P&ID Concept Review
- Procurement Management
- Process Equipment Automation Support
- CIP / SIP Studies & Designs
SERVICE / 03
HVAC & Process Design
Concept and detailed design support for pharma greenfield and brownfield projects — HVAC, process equipment, utilities and P&IDs.
- HVAC Design Support
- Black & Clean Utility Design
- Process Equipment P&ID Concept Review
- Facility Layout Optimisation
SERVICE / 04
Thermal Validation
Comprehensive thermal mapping and qualification for sterilizers, lyophilizers, warehouses and cold-chain equipment.
- Steam Sterilizers
- Dry Heat Sterilizers
- BOD Incubators, Cold Chambers, Refrigerators
- Warehouse, Cold Room & Retention Room Mapping
- Ultra-low Temperature & Cold Chain Services
- Depyrogenation Tunnels
- Mixing Vessels
- Clean Room Mapping
- Lyophilizer Validation
SERVICE / 05
Regulatory & Customer
Audits
Audit support and inspection readiness across Quality Management Systems, Quality Risk Management and site & facility management.
- Management Commitment Reviews
- Site & Facility Management
- Quality Management System
- Quality Risk Management
- GMP Compliance
- Quality Product Assurance
SERVICE / 06
Training Programs
Trainings delivered by industry professionals — covering GMP, data integrity, CSV, soft-skills and behavioural training.
- GMP Training Program
- Good Documentation Practices
- Audit Behavioural Training
- Safety Training
- Risk Assessment
- Data Integrity
- Quality Management Systems
- Soft Skills Training
- CSV Training Program
- Digital Training Module
SERVICE / 07
AMC Services
Annual Maintenance Contracts for all types of process equipment and utilities.
- Vial Filling Lines
- Ampule Lines
- Water Systems
- Blow-Fill-Seal (BFS)
- Tube Filling Lines
SERVICE / 08
Kośa DMS
GxP-compliant Document Management System for SOPs, batch records and technical documents — with version control, ALCOA++ integrity and 21 CFR Part 11 e-signatures.
- Centralized GxP document repository
- ALCOA++ data integrity
- EU Annex 11 lifecycle controls
- AES-256-GCM tamper-evident archiving
- Drafting → review → QA approval workflows
- 21 CFR Part 11 e-records & signatures
- Comprehensive audit trails
- Role-Based Access Control
SERVICE / 09
Kośa LMS
GxP training & competency management — ensuring every employee is trained on the right version of the right document, every time.
- Centralized GxP training assignment & tracking
- ALCOA++ training records
- Audit trails for assignments & overdue items
- Role-based programs that auto-update with SOP revisions
- 21 CFR Part 11 electronic signatures
- Certificates, analytics & dashboards