FDA Compliance & Quality Systems
COMPLETED1. The Situation: Zero Margin for Error
The Stakes: Pharmaceutical manufacturing operates under strict regulatory scrutiny. At Kreative Organics, maintaining US FDA audit readiness was critical for business continuity.
The Gap: The operational workflow required rigorous validation of the SAP ERP system to meet cGMP (Current Good Manufacturing Practice) standards. Any discrepancy in data integrity could lead to audit observations (Form 483) or costly production halts.
2. The Task: Validating the Digital Core
As Technical Project Manager (promoted from Intern within 6 months), I was tasked with leading the Quality Assurance interface between the technical team and regulatory requirements.
Primary Objective: Orchestrate a risk-free transition (cutover) to the new SAP system while ensuring all “Electronic Records” complied with FDA 21 CFR Part 11 protocols.
3. The Action: The V-Model Framework
I implemented a structured V-Model Validation Framework to map technical requirements to testing protocols, serving as the bridge between internal stakeholders and, external SAP partners and consultants.
- CAPA Management: Drove Corrective and Preventive Action initiatives by leading Root Cause Analysis (RCA) sessions for operational deviations, partnering with external SAP Vendors to implement controls that prevent future recurrence.
- SAP Re-qualification: Collaborated with external SAP Consultants to design the validation strategy, but personally executed the OQ/PQ (Operational Performance Qualification) protocols verify the system met FDA standards.
- Precision Execution: Directed the internal/external technical teams during a 5-hour overnight system cutover re-qualification plan to safeguard production continuity and data integrity.
(FDA/cGMP Needs)"]:::input FS["Functional Specs
(SAP Configuration)"]:::input Build["System Build &
Configuration"]:::process OQ["Operational Qualification
(OQ)"]:::logic PQ["Performance Qualification
(PQ)"]:::logic %% Flow URS --> FS FS --> Build Build --> OQ OQ --> PQ %% Traceability Links (Dotted) showing what validates what FS -.-> OQ URS -.-> PQ
Key Contribution: By focusing on Operational & Performance Qualification (OQ/PQ), I verified that the system didn’t just “install” correctly, but actually functioned according to the strict User Requirement Specifications (URS) required by the FDA.
4. The Result
- SAP Re-qualification (system compliance): Successfully executed the re-qualification protocols, verifying that audit trails. Achieved full alignment with cGMP and US FDA regulations through rigorous OQ/PQ execution.
- SOP Standardization (Process): Authored and implemented the Standard Operating Procedures that govern human interaction with the system, bridging the gap between technical capabilities and daily operator workflows.
- Zero Safety Incidents: Maintained a perfect safety record during the tenure while ensuring the facility remained audit-ready.
