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Computer System Validation
Computer System Validation
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.
Global regulatory bodies (as part of their commitment to expedite & speed-up the treatment approvals) promote submission of Manufacturing, clinical trials and all other associated data through electronic submissions.
It is a requirement that the submitted data meets ALCOA + so that the decisions are made quicker. (Accurate, Legible, Contemporaneous, Original, Attributable + Complete)
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.
A wide variety of procedures, processes, and activities need to be validated in this process.
Process parameters and controls are determined during the validation of any process or system.
It helps to determine the worst case and risks that may arise during the manufacturing of the quality products.
Validation helps to investigate the deviations caused during the process
Deep study and understanding of the system equipment are made possible due to the validation and
The risk of the regulatory non-compliance is minimized after the validation.
21 CFR Part 11 Evaluation
21 CFR Part 11 Remediation Plan
21 CFR Part 11 Development Activities
21 CFR Part 11 Ongoing Compliance
System criticality Assessment (GxP/Non GxP – GAMP4/GAMP5)
Assessing and managing the Risks
Decision on Validation and the extent of Validation
Selection of SDLC methodology (Water-fall/Agile/hybrid)
Defining – designing - documenting the Business case & User requirement specification
End to End CSV Validation Project Management
Independent Compliance assessment (21 CFR Part 11)
End to End CSV Documentation
Adjudication and release
Change controls
Training and Operational SOPs
On-Site Qualification kit (if applicable)
Ongoing – Life time Regulatory inspection support
Many more….
CRQA would help you in developing and implementing CSV:
Concept business development
Planning & scoping
Requirements & design
Build
Test
Deploy
Risk assessment level
GAMP5 – CSV Framework for a configured product
For more information, please contact bd@crqa.in or call at +91 9810068241.