GAMP 5 (2022) · 21 CFR Part 11 · EU GMP Annex 11 · NABL CC-2480
PLC / Software
Validation Services
Gujarat's trusted CSV and PLC validation partner — GAMP 5 (2022), 21 CFR Part 11, EU GMP Annex 11, IEC 62443 compliant. PLC/SCADA validation, LIMS/ERP CSV, audit trail verification, data integrity assessment. Full IQ/OQ/PQ. Onsite across Gujarat.
GMP Validated
FDA · EU · GAMP 5
21 CFR Pt 11
Annex 11 Compliant
— WHAT IS PLC / SOFTWARE VALIDATION —
PLC & Software Validation —
Mandatory Under FDA & EU GMP
Computer System Validation (CSV) and PLC validation provides documentary evidence that a computerised system or programmable logic controller consistently performs its intended function — and that electronic records meet the data integrity requirements of FDA 21 CFR Part 11 and EU GMP Annex 11.
EU GMP Annex 11 applies to every computerised GMP system
Any computerised system that replaces a manual operation or can affect product quality, patient safety, or data integrity must be validated per EU GMP Annex 11 — including PLC, SCADA, MES, LIMS, ERP, QMS, and environmental monitoring systems.
21 CFR Part 11 non-compliance is an FDA warning letter risk
FDA warning letters for 21 CFR Part 11 violations (uncontrolled audit trail, insufficient access controls, unvalidated systems) have increased significantly. Prism's CSV service ensures full 21 CFR Part 11 compliance before your next FDA inspection.
Data integrity failures result in import alerts and consent decrees
Manipulated or uncontrolled electronic batch records, audit trail deletions, and shared user IDs are the most common data integrity observations in USFDA and MHRA inspections. Validated systems with proper audit trail are non-negotiable.
Systems Prism Validates
GAMP 5 / 21 CFR Part 11 / EU GMP Annex 11
— WHAT YOU GET —
Every CSV / PLC Validation Includes
GAMP 5 Category Assessment
System categorised per GAMP 5 (2022) — risk-based depth of validation determined before protocol writing. Category 1 through 5 assessment included in validation plan.
21 CFR Part 11 Compliance
Systematic assessment against all 21 CFR Part 11 requirements: electronic records, audit trail, access controls, electronic signatures, backup/recovery, and system validation.
IQ / OQ / PQ Protocols
Hardware IQ, software OQ (functional testing, alarm testing, calculated values, security), and PQ (end-to-end process simulation, audit trail verification) under actual conditions.
Validation Summary Report
Complete CSV package: Validation Plan, IQ/OQ/PQ protocols and reports, 21 CFR Part 11 checklist, ALCOA+ data integrity assessment, deviation log, and Validation Summary Report.
Fast Report Turnaround
Individual system validation reports delivered within 7–10 working days of protocol execution. Complex multi-system projects delivered per agreed milestones.
Audit Trail Verification
Complete audit trail review — verifying that all operator actions, parameter changes, alarm acknowledgements, and electronic records are captured and cannot be modified or deleted.
Vendor / Supplier Qualification
Supplier assessment (vendor qualification) per EU GMP Annex 11 Clause 3 — review of supplier quality system, development lifecycle, and documentation package.
Periodic Review Service
Annual periodic review of validated systems per EU GMP Annex 11 Clause 11 — confirms the system remains in a validated state with updated documentation.
GAMP 5 · 21 CFR Part 11 · EU GMP Annex 11
Need PLC / Software Validation in Gujarat?
Full CSV lifecycle · GAMP 5 methodology · FDA and EU GMP accepted
— OUR PROCESS —
PLC / Software Validation — The CSV Lifecycle
GAMP 5 Category Classification & Risk Assessment
System categorised per GAMP 5 (2022): Category 1 (infrastructure), Category 3 (non-configured), Category 4 (configured), or Category 5 (custom). Risk assessment determines validation depth — critical process parameters, data integrity risks, and regulatory impact assessed per ICH Q9.
Validation Plan & IQ Protocol
System-specific Validation Plan drafted with scope, approach, roles, and acceptance criteria. IQ protocol documents hardware, operating system, software version, network configuration, user access management, backup/recovery setup, and security configuration.
Functional Specification & OQ Protocol
Functional and design specifications reviewed or authored. OQ protocol tests all functional requirements: input/output verification, alarm testing, calculated value verification, security testing, data storage and retrieval, and performance under load.
PQ — Process Performance Testing
PQ tests the software/PLC system under actual process conditions — end-to-end process simulation, electronic batch record generation, audit trail completeness verification, and data integrity checks under simulated production use.
21 CFR Part 11 / Annex 11 Compliance Assessment
Systematic assessment of the system against 21 CFR Part 11 (USA) or EU GMP Annex 11 requirements — electronic records, electronic signatures, audit trail, access controls, backup, disaster recovery, and data integrity (ALCOA+ principles).
Validation Report & Change Control
Complete CSV/PLC validation package issued: Validation Plan, IQ/OQ/PQ protocols and reports, GAMP 5 category assessment, 21 CFR Part 11/Annex 11 compliance checklist, deviation log, and Validation Summary Report — with ongoing change control procedure.
Industry Applications
Industries That Require PLC / Software Validation
Pharmaceutical Manufacturing
PLC/SCADA validation for tablet compression, filling, coating, and packaging lines. CSV for MES, LIMS, ERP, and QMS systems per GAMP 5, 21 CFR Part 11, EU GMP Annex 11.
Know MoreAPI & Bulk Drug Manufacturing
PLC validation for batch reactors, dryers, centrifuges, and granulators. SCADA system qualification for API process control per FDA 21 CFR Part 211 and EU GMP.
Know MoreMedical Device Manufacturing
Software validation (SaMD and manufacturing software) per IEC 62304, ISO 13485, and FDA 21 CFR Part 820 QSR. GAMP 5 approach applied.
Know MoreBiotechnology & Biologics
Bioreactor PLC and SCADA validation for biologics and vaccine manufacturing per FDA 21 CFR Part 600 and EU GMP Annexes 2 and 11.
Know MoreHospital Pharmacy Systems
Pharmacy management software and automated dispensing system validation per NABH and hospital GMP (Schedule H/X) requirements.
Know MoreLIMS & Laboratory Systems
LIMS, chromatography data systems (CDS), and spectroscopy software validation per 21 CFR Part 11, EU GMP Annex 11, and OECD GLP principles.
Know MoreEnvironmental Monitoring
Continuous environmental monitoring system (CEMS) and BMS software qualification for GMP clean rooms per EU GMP Annex 1 (2022) and Annex 11.
Know MoreERP & Quality Systems
SAP, Oracle, and other ERP/QMS system CSV per GAMP 5 Category 4 — supplier qualification, IQ/OQ/PQ, 21 CFR Part 11 compliance, and periodic review.
Know MoreWhy Choose Prism
Two Decades of GMP Validation.
Zero Audit Observations.
Since 2004, every CSV and PLC validation report issued by Prism has been accepted by USFDA, MHRA, EU GMP inspectors, and GPCB auditors — no observations, no 483s, no rework.
— STANDARDS & COMPLIANCE —
Standards We Follow for CSV / PLC Validation
GAMP 5 (2nd Ed, 2022)
ISPE good automated manufacturing practice
FDA 21 CFR Part 11
Electronic records and signatures
EU GMP Annex 11 (2011)
Computerised systems
ICH Q10
Pharmaceutical quality system
OECD GLP
Good laboratory practice principles
IEC 62304
Medical device software lifecycle
ISPE GAMP COP: Data Integ
ALCOA+ data integrity guidance
ISO/IEC 17025:2017
NABL accreditation CC-2480
GAMP 5 (2022) + Zero Observations Since 2004
Every CSV and PLC validation report is based on GAMP 5 (2022) methodology and accepted in USFDA, MHRA, EU GMP, and GPCB inspections — zero 483s or observations since Prism was founded.
500+
Systems Validated
0
Audit Observations
— NON-GMP SOFTWARE VALIDATION —
Software Validation for Non-GMP Industries
ISO 9001, ISO 13485 (medical devices), IATF 16949 (automotive), and ISO/IEC 17025 (laboratories) all require documented software and system validation. Prism offers software validation for non-GMP applications using GAMP 5 principles at cost-effective pricing.
Risk-Based Approach
GAMP 5 risk-based approach applied to non-GMP validation — appropriate depth for your industry.
Faster Turnaround
Non-GMP software validation completed in 5–7 days for most systems.
Flexible Scope
IQ/OQ only or full validation lifecycle — scoped to your requirement.
Onsite & Remote
Validation executed onsite at your facility or remotely — your preference.
Onsite Coverage
Serving All
of Gujarat
Validation engineers based in Ahmedabad cover all Gujarat pharma and industrial zones.
— VALIDATION SERVICES —
Validation Services We Offer
8 GMP validation services — all under one NABL-accredited roof. View all services →
Clean Room Validation
4 test parameters
- ISO 14644-1 Particle Count
- HEPA Filter PAO/DOP Test
- ACH & Airflow Velocity
- Differential Pressure Cascade
Autoclave / Sterilizer
4 test parameters
- Temperature Distribution Study
- Heat Penetration Study
- IQ / OQ / PQ Documentation
- Bowie-Dick & Leak Test
Stability Chamber
4 test parameters
- T&H Mapping (ICH Q1A)
- Uniformity Verification
- IQ / OQ / PQ Protocols
- Data Logger Calibration
DQ / IQ / OQ / PQ
4 test parameters
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
AHU Validation
4 test parameters
- Airflow & Velocity Balancing
- HEPA Integrity Testing
- Pressure & ACH Verification
- Filter Efficiency Testing
PLC / Software Validation
4 test parameters
- 21 CFR Part 11 Compliance
- GAMP 5 Validation
- IQ / OQ / PQ for Software
- Audit Trail Verification
Thermography / Oven
4 test parameters
- Hot Air Oven Temperature Mapping
- Thermal Distribution Study
- Infrared Thermography
- IQ / OQ / PQ Documentation
Performance Qualification
4 test parameters
- Worst-Case PQ Testing
- Process Performance Study
- Statistical Acceptance Criteria
- GMP-Ready PQ Report
— Our Clients —
Trusted By Gujarat's Leading Pharma Companies
— CLIENT VOICES —
What Our CSV Validation Clients Say
Prism completed GAMP 5 Category 4 validation for our SCADA/PLC-based tablet compression control system — URS, FS, DS, IQ/OQ/PQ protocols, 21 CFR Part 11 compliance assessment, and audit trail verification. Accepted in USFDA PAI without observations.
EU GMP Annex 11 CSV validation for our ERP (SAP) and LIMS system by Prism. Full validation lifecycle per GAMP 5 — qualification plan, IQ/OQ/PQ protocols, security testing, audit trail, and backup/recovery test. EU GMP inspection accepted the package.
21 CFR Part 11 compliance assessment and remediation for our existing batch record systems by Prism. Gap analysis, risk assessment, and updated validation documentation delivered in 2 weeks. FDA inspection accepted all records.
Prism completed GAMP 5 Category 4 validation for our SCADA/PLC-based tablet compression control system — URS, FS, DS, IQ/OQ/PQ protocols, 21 CFR Part 11 compliance assessment, and audit trail verification. Accepted in USFDA PAI without observations.
EU GMP Annex 11 CSV validation for our ERP (SAP) and LIMS system by Prism. Full validation lifecycle per GAMP 5 — qualification plan, IQ/OQ/PQ protocols, security testing, audit trail, and backup/recovery test. EU GMP inspection accepted the package.
21 CFR Part 11 compliance assessment and remediation for our existing batch record systems by Prism. Gap analysis, risk assessment, and updated validation documentation delivered in 2 weeks. FDA inspection accepted all records.
Prism completed GAMP 5 Category 4 validation for our SCADA/PLC-based tablet compression control system — URS, FS, DS, IQ/OQ/PQ protocols, 21 CFR Part 11 compliance assessment, and audit trail verification. Accepted in USFDA PAI without observations.
EU GMP Annex 11 CSV validation for our ERP (SAP) and LIMS system by Prism. Full validation lifecycle per GAMP 5 — qualification plan, IQ/OQ/PQ protocols, security testing, audit trail, and backup/recovery test. EU GMP inspection accepted the package.
21 CFR Part 11 compliance assessment and remediation for our existing batch record systems by Prism. Gap analysis, risk assessment, and updated validation documentation delivered in 2 weeks. FDA inspection accepted all records.
Get In Touch
Request a Free Quote
Tell us the system to validate (PLC, SCADA, LIMS, ERP, etc.), regulatory requirement, and timeline. Our team responds within 2 business hours.
— FAQ —
PLC / Software Validation — FAQ
Need PLC / Software Validation in Gujarat?
Call or WhatsApp — we reply within the hour. GAMP 5 compliant validation report guaranteed.
Prism Calibration Centre · F 101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Ahmedabad, Gujarat 382445
— FROM OUR BLOG —
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Read MoreValidation Services Disclaimer
PLC and software validation services are performed per GAMP 5 (2022), FDA 21 CFR Part 11, EU GMP Annex 11, and applicable regulatory guidelines. All test instruments are NABL calibrated under Certificate CC-2480 (ISO/IEC 17025:2017).