Draft a peer-review checklist that confirms technical-consulting DevOps toolchain configurations meet FDA 21 CFR Part 11 electronic-records standards

Client DevOps Toolchain Configuration Files *

FDA Submission Type Context * Choose FDA submission category... Medical Device Software (SaMD) Pharmaceutical Clinical Trial Data In-Vitro Diagnostic Device (IVD) Datasets Combination Product Safety Data Biologics Manufacturing Records Generic Drug ANDA Submissions Biosimilar REMS Documentation Digital Therapeutic Solutions Companion Diagnostic Development Real-World Evidence Studies 510(k) Premarket Submissions PMA (Premarket Approval) Support

Electronic Records Scope * Select record categories... Raw analytical instrument data Electronic batch records (EBR) Clinical trial data sets (eSource) Electronic signatures on protocols Quality management system records CAPA and deviation investigations Manufacturing execution system logs Laboratory information management (LIMS) Supply chain traceability records Audit trail repositories Electronic Common Technical Document (eCTD) Regulatory risk management files

Stakeholder Audit Requirements * Choose audit stakeholder... FDA Center for Devices and Radiological Health (CDRH) FDA Center for Drug Evaluation and Research (CDER) European Medicines Agency (EMA) Health Canada Inspectorate ISO 13485 Notified Body auditors 21 CFR Part 11 compliance consultants Pharmaceutical client GxP audit teams Medical device manufacturer QA auditors Third-party validation service providers Internal corporate compliance teams Joint FDA inspection teams (US-EU mutual recognition) PICS (Pharmaceutical Inspection Co-operation Scheme) auditors

Validation Approach Risk Level * Choose risk-based validation approach... High (Direct patient safety impact) Medium (Quality system impact) Low (Administrative impact only) Critical Path (Product quality attribute) GxP Direct (Regulatory submission affected) Operational Priority (Manufacturing critical) Business Continuity (Enterprise system) Periodic Review (Routine revalidation) Initial Qualification (New implementation) Change Control (Post-implementation update)

Compliance Telemetry Points *

Electronic Signature Requirements *

System Validation Timeline * Choose timeline based on submission type... Phase I - 4 weeks standard validation Phase II - 6 weeks enhanced validation Phase III - 8 weeks comprehensive validation PMA - 12 weeks full qualification cycle 510(k) - 3 weeks expedited validation ANDA - 5 weeks generic validation Breakthrough Device - 6 weeks parallel validation Emergency Use - 10 days emergency qualification Continuous Monitoring - 2 weeks periodic review Post-approval Change - 8 weeks change control

Custom GCP/CMO Requirements

Quality Output Specifications * Choose output format... Red-lined Word document with tracked changes PDF validation master plan with annexes Excel-based traceability matrix PowerPoint executive summary for C-suite Controlled document via MasterControl or similar JSON/XML machine-readable checklist Regulatory-ready technical report Client-branded template per corporate standards Version-controlled Git repository export Validation summary table for eTMF filing