Today, companies in pharmaceuticals, biotechnology, and medical devices are not only evaluated by the quality of their products, but also by their ability to comply with regulations. In this context, 21 CFR Part 11 stands out as a crucial regulation that governs the integrity, reliability, and traceability of electronic records and signatures.
At WAGONN, we design software architectures that are both technically robust and fully aligned with FDA standards. While we are not a certification or auditing body, we help our clients implement the technical foundations they need for successful compliance initiatives.
1. Foundational Principles of Compliance-Oriented Software Design
21 CFR Part 11 requires systems to have:
- Audit Trails: Every change must be traceable by date, time, and user.
- Electronic Signatures: Authenticated users must digitally sign actions.
- User Authentication: Access must be controlled and verified.
- Data Integrity: Records must remain original, secure, and unaltered.
These are not just technical capabilities, but structures that must align with corporate quality systems. At WAGONN, we build solutions that support not just code, but also the broader business process.
2. Custom Architectures for Unique Needs
Compliance needs vary widely. Some organizations require integration with existing LIMS systems, while others focus on digitizing documentation. WAGONN develops integrated solutions that minimize the need for disruptive restructuring and lower implementation costs.
3. Supporting IQ/OQ/PQ Validation Workflows
Validation is a cornerstone of compliance. At WAGONN, we provide software structures that support the following key validation phases:
- IQ (Installation Qualification): Demonstrates that the software is installed correctly in the target environment, with all components configured appropriately. Our implementations facilitate easy documentation of this process.
- OQ (Operational Qualification): Confirms that the system functions as intended under defined conditions. WAGONN ensures support for business rule validations, access control mechanisms, and data capture processes that align with OQ expectations.
- PQ (Performance Qualification): Verifies system performance under real-world conditions. We design flexible systems that allow clients to run test scenarios reflective of daily operations.
While these activities are managed by the client’s internal quality teams or external consultants, we focus on delivering the infrastructure necessary for these validations to be successful.
4. Transparency and Audit Readiness
FDA inspections may come unannounced. Our solutions are designed to be fully auditable at any moment, with robust logging, time stamping, and role-based access controls.
5. Compliance as a Competitive Advantage
FDA-compliant systems not only ensure successful audits, they also boost your company’s reputation and readiness to operate in regulated global markets.
