Internal Compliance Assessment Methods

FDA Warning Letter snippet: Facility has areas not maintained and in a state of decay. QMR identified significant gaps in training which were not addressed effectively. Sterile operations were not maintained with basic requirements being ignored and willfully violated. What can you do about these issues: The GxP compliance process of Align, Apply, and Adapt is a structured approach to ensuring that GxP standards are effectively integrated into an organization’s operations. Here’s how this framework works: 1. ALIGN – Establishing Compliance Foundations This phase ensures that the company’s policies, procedures, and systems are aligned with regulatory expectations and industry best practices. Key Activities: ✔ Regulatory Landscape Assessment – Identify applicable FDA guidelines. ✔ Gap Analysis – Assess current systems against regulatory requirements and industry benchmarks. ✔ Quality & Compliance Framework Development – Establish or refine SOPs, policies, and quality systems. ✔ Stakeholder Buy-In – Ensure leadership and teams understand compliance priorities and objectives. 📌 Outcome: A clear compliance roadmap that aligns business operations with regulatory expectations. 2. APPLY – Implementation & Execution Focuses on applying compliance principles into daily operations to ensure processes are followed consistently and effectively. Key Activities: ✔ Training & Competency Development – Conduct role-specific GMP training for employees. ✔ Process Integration – Embed compliance into manufacturing, quality control, and clinical operations. ✔ Data Integrity & Documentation – Ensure ALCOA+ principles are met. ✔ Routine Monitoring & Self-Inspections – Conduct internal audits and quality reviews to identify gaps before regulatory inspections. 📌 Outcome: Compliance becomes part of the company’s operational culture, not just a checkbox activity. 3. ADAPT – Continuous Improvement & Risk Management Since regulations and business environments evolve, organizations must continuously adapt their compliance approach to remain inspection-ready and competitive. Key Activities: ✔ Regulatory Change Management – Monitor FDA updates and enhance policies accordingly. ✔ Process Optimization – Leverage insights from deviations, CAPAs, and audit findings to improve compliance efficiency. ✔ Technology & Automation – Implement digital compliance tools to enhance data integrity and reduce human error. ✔ Culture of Compliance – Foster a mindset where compliance is proactive rather than reactive. 📌 Outcome: A resilient, future-proof compliance program that evolves with regulatory changes and business needs. Why This Approach Matters 🔹 Prevents last-minute compliance scrambles before inspections. 🔹 Reduces regulatory risk and ensures inspection readiness at all times. 🔹 Increases operational efficiency by integrating compliance into day-to-day processes. 🔹 Supports scalability, ensuring compliance remains strong as the company grows.

🔍 Data Integrity (DI) Remediation & Validation in Biomanufacturing: Compliance is Non-Negotiable! In cGMP biomanufacturing, data integrity (DI) is the backbone of compliance. Without robust DI controls, the risk of regulatory scrutiny, product recalls, and patient safety issues escalates. Yet, many facilities still struggle with DI gaps, leading to FDA 483s, Warning Letters, and even Consent Decrees. So, how should organizations approach DI remediation and validation effectively? ⚠️ Common DI Pitfalls in Biomanufacturing ❌ Incomplete or altered records – Missing or manipulated batch records, audit trails, and electronic data raise red flags. ❌ Lack of ALCOA+ principles – Data must be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. ❌ Inadequate system controls – Poorly configured manufacturing execution systems (MES), laboratory information management systems (LIMS), and electronic batch records (EBRs) can compromise DI. ❌ Unvalidated data systems – Failure to validate computerized systems leads to unreliable data and regulatory noncompliance. 🔄 DI Remediation: A Risk-Based Approach A reactive approach to DI remediation is not enough. A well-structured DI remediation plan should include: ✅ Gap Assessment & Risk Prioritization – Identify DI gaps across paper-based and electronic systems. Prioritize remediation based on product impact and regulatory risk. ✅ Governance & Training – Establish DI policies, SOPs, and cross-functional training programs to embed a culture of DI compliance. ✅ Data Lifecycle Management – Implement controls for data generation, processing, storage, and retrieval to ensure compliance throughout the product lifecycle. ✅ Audit Trail Reviews & Exception Handling – Routine monitoring of electronic data trails to detect and correct DI issues before inspections. ✅ Periodic DI Assessments – Continuous review of DI controls through internal audits and self-inspections to maintain readiness. 📊 DI Validation: Ensuring Trustworthy Data Validation of GxP computerized systems ensures that data is reliable, accurate, and compliant. Key steps include: 🔹 System Risk Assessment – Categorize systems based on DI risk to determine validation effort. 🔹 21 CFR Part 11 Compliance – Ensure electronic signatures, access controls, and audit trails meet regulatory expectations. 🔹 IQ, OQ, PQ Execution – Verify system installation, operation, and performance meets DI requirements. 🔹 Periodic Review & Revalidation – Validate updates, patches, and system changes to maintain DI compliance over time. 🏆 DI Excellence = Compliance + Business Success A proactive DI strategy strengthens compliance, minimizes regulatory risk, and improves manufacturing efficiency. Organizations that invest in DI remediation and validation today will be the ones achieving inspection readiness and long-term success in biologics and cell & gene therapy manufacturing. #DataIntegrity #GMPCompliance

Day 21 of 30: How to Conduct a Simple Risk and Control Self-Assessment (RCSA) A lot has been said about internal controls in the past 20 days. Today, I want to speak briefly about how to conduct a simple risk and control self assessment. Risk and Control Self-Assessment (RCSA) is a structured internal process through which an organization’s business units identify, assess, and document key operational risks and controls within their activities. RCSA is typically conducted by the process owners themselves, hence “self-assessment” tool for strengthening risk management and internal control. It doesn't have to be a lengthy or intimidating process. In fact, some of the most effective assessments are simple, focused, and collaborative. Here’s how to run one in your team without needing a complex system or external consultants: Step-by-Step Guide to a Simple RCSA ✅ 1. Identify your key processes What does your team do daily that affects operations, money, data, or compliance? Focus on core processes like approvals, inventory handling, reporting, etc.   ✅ 2. Spot the risks You identify most risks by asking “What could go wrong in this process”? Think in terms of errors, fraud, delays, miscommunication, or system failure. In procurement for instance, a key risk could be ordering without proper approval.   ✅ 3. Map existing controls Clearly identify the controls that already exist in the system. What is already in place to prevent or detect the identified risks? Document policies, system controls, checks, reconciliations, or supervisory reviews.   ✅ 4. Assess effectiveness Are the controls working? Are there gaps? Are they being bypassed? You can use a simple rating scale (e.g., Effective / Needs Improvement / Not in Place) for proper assessment.   ✅ 5. Define Action Steps Where gaps exist, identify practical actions — such as training, system tweaks, or new checks.   Bottom Line: Keep in mind that the session need to be interactive and blame-free. Also, real life examples enhances team members’ quick connection to the process. Furthermore, there should be proper documentation and regular revisiting of controls because controls are only as good as they are updated. “RCSA is not just a compliance checkbox but a proactive culture of accountability.” It is about empowering your team to own their risks and controls. Start small, stay consistent. #Day21 #InternalControlChallenge #RCSA #RiskManagement #InternalAudit #Governance #ControlsThatWork #AuditReady

Internal Audit Process: 1. Planning Phase Objective: Establish a clear understanding of the audit subject and develop a roadmap (audit program) for executing the audit effectively. Key Activities: > Initial Contact & Information Gathering: Understand the size, responsibilities, and procedures of the audited unit. > Risk Assessment: Performed to identify high-risk areas for focus. > Audit Objectives & Methodology: Defined and documented through the audit program. > Notification Letter: Sent to leadership to inform them of the audit. May include a pre-audit questionnaire or document request list. > Entrance Meeting: Discuss audit scope and objectives. Explain methodology and timeline. Identify scheduling concerns (e.g., staff availability). Encourage input on known risks and areas of concern. 2. Fieldwork Phase Objective: Evaluate internal controls, compliance, and operational effectiveness through testing and inquiry. Key Activities: > Testing & Documentation Review: Examine transactions, records, and procedures. > Staff Interviews: Conducted to gain deeper insights into practices and control execution. > Disruption Minimization: Work is coordinated to limit interference with operations. > Ongoing Communication: Frequent updates and discussions with audit clients. > Collaborative Analysis: Observations and issues are discussed with management to identify root causes and explore solutions. 3. Reporting Phase Objective: Present audit findings, recommendations, and management’s corrective action plans in a formal written report. Key Activities: > Draft Report: Initially shared with local management for review. > Management Response: Required for each recommendation, including: Action plan. Responsible person. Implementation date. > Exit Meeting: Held if needed to address concerns and clarify findings before finalizing the report. > Final Distribution: The final report is sent to Management and Boards. 4. Follow-Up Phase Objective: Ensure that corrective actions are implemented effectively and that issues are resolved. Key Activities: > Verification Procedures: May involve document review, staff interviews, or re-auditing specific processes. > Ongoing Tracking: Open findings are tracked and presented at each Institutional Audit Committee (IAC) meeting. > Escalation for Delays: If action plans miss deadlines, the responsible party must submit a written explanation. Repeated delays require in-person explanation to the IAC.