mba solutions specializes in providing guidance in the validation of computerized systems to comply with the Health Canada and Food and Drug Administration (FDA) Standards that require data to meet specific fundamental elements of quality. These fundamental elements require source records that are created, maintained, or transmitted electronically to be attributable, legible, contemporaneous and be auditable. To assist in satisfying these requirements, we offer the following:
System validation lifecycle management and periodic review
Guidance in the development of procedural documentation (SOPs).
Guidance in formal testing practices
Health Canada / FDA 21 CFR Part 11 training and awareness
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How Do I Know If My System Needs Validating?
Software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use needs be validated. While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they do require that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a high degree of assurance that a specific process will consistently produce the expected result. Whether vendor purchased, custom built or in the cloud, the system must demonstrate that it meets the requirements of Health Canada and FDA 21 CFR Part 11. Not complying may result in an observation, warning or other sanctions.
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What is System Validation?
System validation is the process of testing and documenting that a computer system functions as intended for its use and in the context of the research conducted. The process, as a whole consists of the hardware, software, people and processes that interact; with an end goal of data quality, data protection and patient safety. Required documentation in a validation must align with the industry standards and regulatory laws that guide the Regulatory Agencies in their evaluation and enforcement of compliance. System validation benefits are:
Reduction in regulatory liability
Reduction in long-term costs in system implementation, management and use
A standardized and repeatable process towards quality in a system
Performance assurance to manage a given cGxP process.
Electronic evidence that sustains compliance based on proven functionality and user requirements
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Procedural Controls
Documentation of procedural controls are required by Health Canada and made available upon request. They are generally in the form of standard operating procedures (SOPs) and user manuals.
Common documented procedures are:
User account management
Remote access for vendor accounts
Backup and Recovery
Good data management practices
Change control
Training (User and System)
Application and System Security
The content developed in your SOPs must address the system validation concepts which follow Federal regulations.
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Are there training requirements for compliance?
All Users (including system administrators and analysts) must have the necessary education, training, and experience before being granted to access the computer system. This includes training on relevant SOPs. Completion of training must be documented and retained.
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To discuss your validation, compliance or project management needs please contact us at