Our Services

01

Computer System Validation (CSV)

End-to-end CSV as per GAMP 5, 21 CFR Part 11 and EU Annex 11 for all GxP computerized systems.

• URS, FS, DS, Risk Assessment
• IQ / OQ / PQ protocols & reports
• 21 CFR Part 11 & Annex 11 compliance
• Traceability Matrix & Validation Summary Report

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02

HPLC & Lab Instrument Validation

Qualification and software validation of HPLC, GC, UV and other QC laboratory instruments.

• Chromatography Data System (CDS) validation
• Audit trail & data integrity review
• User access / privilege verification
• Periodic review & re-qualification

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03

PLC Validation

Validation of PLC-based process equipment used in pharmaceutical manufacturing.

• Hardware & software design verification
• I/O checks and interlock testing
• Alarm & sequence verification
• Power failure & recovery testing

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04

HMI Validation

Validation of Human Machine Interfaces including security, recipes, alarms and audit trails.

• User level & password policy testing
• Electronic records / signatures
• Recipe management verification
• Screen navigation & alarm testing

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05

SCADA Validation

Validation of SCADA, BMS and EMS systems for complete plant-wide data integrity.

• Data acquisition & trend verification
• Report & historian validation
• Backup / restore & archival testing
• Network & security verification

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06

Excel Spreadsheet Validation

Development and validation of GxP Excel spreadsheets for QC, QA and production calculations.

• Locked & protected calculation templates
• Formula verification with test data
• Spreadsheet validation documents
• Version control & change management

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07

Hardware & Electronics Supply

Supply of industrial hardware, computers, networking and electronic components for pharma plants.

• PLC, HMI & automation components
• Computers, servers & networking
• Sensors, data loggers & electronics
• Installation & after-sales support

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08

Custom Software Development

New software development for pharma and other industries — web, desktop and mobile applications.

• Requirement study & design
• Web / desktop application development
• Validation-ready (GAMP 5) documentation
• Deployment, training & support

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