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….

• Concept business development
• Planning & scoping
• Requirements & design
• Build
• Test
• Deploy
• Risk assessment level
• GAMP5 – CSV Framework for a configured product