Software Validation
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.
Computer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity for a business to examine their compuComputer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality.ter systems to maximize effectiveness and enhance quality.
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MAXIMIZE THE BENEFITS OF
COMPUTER SYSTEM VALIDATION
Xeeor can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We have written (and executed) commercially available validation packages. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.
We can follow your existing validation procedures or provide your company with validation standards.
Validation
Methodology
The challenge of meeting a growing number of regulations
Xeeor can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle.
Document the system functional requirements. Functional Requirements describe what actions the database must be able to perform. This includes:
• Data to be entered into the system or database
• Formulas or calculations used on each screen or form
• Identifying who can enter the data into the system
• Identify how the system meets applicable regulatory requirements, especially 21 CFR 11
Design Specifications describe how the database accomplishes the functional requirements. Xeeor uses proprietary tools to analyze your system or database to create comprehensive design specifications. Design specifications include:
• Inputs – Data entry, validation rules, etc.
• Processing – Workflow enforcement, code, macros, etc.
• Outputs – Reports, data exports, etc.
• Security – User level security, data protection, etc.
Once requirements have been outline and documented, Test Plans are developed to demonstrate that all required system functionality is met and the system is properly secured. Our validation professionals will document a testing protocol, designed to demonstrate that your form meets all of your business requirements and regulatory requirements outlined by 21 CFR Part 11. As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.
Throughout the process, a Traceability Matrix is updated to ensure that all system requirements are addressed. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.
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