Embedded Files
Laboratory Software: CSV of Chromeleon, Empower, Lab Solutions, Open Lab CDS, TOC-L, Qtegra, PharmSpec, Tiamo, UVProbe, Polarimeter, Rudolph Research Analytical, Analyst, Many more...
Laboratory Instrument: HPLC, LCMS, GC, GCMS, GCHS, UV, FTIR, LPC, Stability Chamber, Karl Fisher, ICP-MS, ICP-OES, Polarimeter, Many more...
The process of establishing written proof that offers a high level of assurance that a certain process will consistently result in a product that satisfies preset standards and quality attributes is known as computer system validation.
The following documents will be supplied by AyaanSky
Validation Master Plan (VMP)
System Inventory List
GAP Assessment Protocol/Report
Validation Plan
System Classification (GxP Assessment/Initial Risk Assessment)
System Requirement Specification
System Desing Specification (For Server/Network)
Infrastructure Risk Assessment (Pre & Post)
Functional Risk Assessment (Pre & Post)
Network Qualification/Infrastructure Qualification Protocol/Report
Installation Qualification Protocol/Report
Operational Qualification Protocol/Report
Performance Qualification Protocol/Report
Validation Summary Report
Requirement Traceability Specification
21 CFR Part 11
It is entirely up to you how you wish to validate your computerized system or systems in terms of methodology and life cycle.
The GAMP5 methodology is the most widely used and well-known approach to software validation.
Testing during CSV aims to protect patient safety, product quality, and data integrity by making sure systems are dependable, accurate, secure, and compliant. It goes beyond simply fulfilling regulatory criteria such as FDA 21 CFR Part 11, EU Annex 11, and GxP principles. CSV testing is a continuous process with several phases, each with unique goals and tests; it is not a one-time event.
How We Handle Computer System Validation Assignments
We'll make sure your validation conforms with rules set forth by the FDA, EMA, MHRA, and other agencies:
A standard set of software validation templates, including the Validation Plan, System Requirements, Validation Protocols, and the Validation Report, is brought by our validation experts.
Conduct a risk assessment of the system.
Create a validation plan that is suitable for the degree of system risk.
Document user requirements and functional specifications in collaboration with your team.
Create test strategies and provide validation protocols (IQ, OQ, PQ, etc.)
Carry out the validation protocols and provide the necessary test reports.
Provide inspections when they're ready. Test Report and Summary of Validations
Our validation specialists can collaborate with you remotely or at your location, according on what best suits your demands and financial situation.
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