Computerized System Validation
COMPUTER SYSTEM VALIDATION
Computerized system validation framework to achieve and maintain GxP compliance throughout the computerized system life cycle. This framework is based on system specific validation plans and reports and the application of appropriate operational controls.
Validation plans and reports provide a disciplined and consistent approach to meeting regulatory requirements, leading to appropriate documentation at the right level. Such documents are valuable both in preparing for, and during, regulatory inspections. Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. (Ref.: 21 CFR 11.10 (a)). A computerized system consists of the hardware, software, and network components, together with the controlled functions and associated documentation. (Ref.: ISPE GAMP5).
We provide following deliverables as per current GAMP guideline and comply with 21 CFR Part11:
Arizona Provides following length of full services in CSV Validation.
- Process Control System Validation (PLC/HMI/ IPC/ SCADA/DCS System Validation)
- Laboratory Equipment Software Validation (HPLC, GC, FTIR, Spectrometer, UV, LCMS-MS and More)
- Building Management System (BMS) and Environment Management System (EMS) System Validation
- LIMS, EMPOWER, LabVIEW, Specialty Software Validation
- Aggregation, Serialization, Track and Trace, TracLINK, ReeTrak, L1 to L5 Integration Validation, Warehouse Management Software Validation.
- Analytical Software Validation (Chromeleon, SAS, WinOnlin & more)
- Enterprise Application Software Validation (SaaS, SAP, ERP, MES, LMS, TMS)
- Excel Sheet development and Validation as per CFR Tittle 21 Part 11
- Cloud, Server, Network and IT infrastructure validation
- Customize Software Validation
- Desktop Validation, Meta data Validation
- CFR Tittle 21 Part 11 Assessment, GAP Assessment, GXP Assessment, Impact Assessment.
- CSV Audit and Audit Support, CSV Training.
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Commissioning, qualification and validation(CQV)
Commissioning, qualification and validation, also known as CQV, is a complex, multi-step process. Commissioning ensures that facilities, systems and equipment are designed and installed as specified and function as intended. Qualification ensures equipment and systems function to produce products correctly. Validation ensures that the final product is built correctly.
- Arizona offers you full-service support to track and keep your project up to date and completed within the specified timeline, largely owing to our professional and experienced team.
Data integrity
Data integrity refers to the completeness, consistency, and accuracy of data. where data are Attributable, Legible, Contemporane¬ous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+).
| Attributable – Who performed the action or acquired the data and when? | Complete – Are all data, including changes, included, | |
| Legible – Can the data be easily read and are they indelible? | Consistent - Is there consistent generation of records and application of time stamps? | |
| Contemporane¬ous – Are the data documented at the time of the activity? | Enduring – Are data recorded in a manner which will enable them to last for the intended duration? | |
| Original – Are data recorded from an original observation or a certified copy? | Available – Are data available for review and audit during their entire life cycle? | |
| Accurate – Is the information complete consistent and correct? | Traceable – Are data traceable throughout the process? |
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A-607, Siddhi Vinayak Business Tower
Ahmedabad, Gujarat 380051
India
Flat 1, 60 cardiff road, Newport
NP20 2 EG
Email Us
info@arizonaautomation.in
contact@arizonaautomation.in
Call Us
+91 9909786331
+971 509310159
+44 776 793 5850
+1 732 642-7966
+1 647 624-4789