FDA 21 CFR Part 11 Compliance Support
Achieving FDA 21 CFR Part 11 compliance is critical for life sciences organizations. Alidade Technology provides comprehensive support to ensure your IBM Engineering Lifecycle Management (ELM) system meets all regulatory requirements for electronic records and signatures.
Alidade Technology assists customers with process definition and governance practice development to utilize the IBM Engineering Lifecycle Management (ELM) tools as their system of record.
Our team helps with the following activities:
• Assistance with the overall process for generating FDA 21 CFR Part 11 compliant documentation.
• Help with the use of the ELM tools as the system of record for requirements, risk documentation, traceability, and test documentation.
• Establish ELM project templates to fit our clients' needs, considering their current document tree and hierarchy.
• Establish reporting tools and templates to support audits and FDA submissions.
• Draft SOPs for tool use.
• Assist in software validation of the ELM tool suite including protocols, dry runs, and reports.
• Help customers migrate from existing tools to ELM, including drafting the migration approach from the current system of record and sustained effort for migration.
Digital Signature Workflows: Implementing compliant electronic signatures requires precise process definition. We assist in designing governance practices that leverage IBM's built-in authentication mechanisms, ensuring that every approval is attributable, legible, contemporaneous, original, and accurate (ALCOA principles).
Validation and Documentation: Our team supports the technical validation of your ELM installation. From IQ/OQ/PQ support to methodology coaching, we ensure your engineering organization is prepared for audits with comprehensive reporting and clearly defined software-intensive lifecycle management.