How to Improve Compliance Programs

After implementing compliance programs for 2000+ companies, here's what we've learned: 42% of control failures trace back to documentation gaps. Should that matter?Absolutely! Here’s why:  1️⃣ It's a Productivity Black Hole: Compliance teams spend 40–60% of their time chasing documents instead of managing risk. 2️⃣ It Leads to Audit Gaps: Missing or outdated evidence leads to failed audits, escalations, and costly remediation.  3️⃣ It Hinders Business Agility: Manual processes delay M&A, funding rounds, and strategic deals. The Strategic Solution: Common Control Framework ✅ One Control Set for Multiple Standards -Map SOC 2, ISO 27001, HIPAA to unified controls (cut duplicate work) -Evidence collected once satisfies multiple requirements ✅ Automated Evidence Ecosystem -Direct integrations with AWS, GitHub, Okta auto-collect proof -System owners get smart reminders for human-verified items ✅ Executive Visibility -System data flows directly into compliance platforms -Centralized system eliminates version control issues The Bottom Line Impact Companies using this approach with Sprinto have: ✔️ Reduced audit prep time to weeks like Bizongo ✔️ Cut compliance costs by 50% like Makeforms ✔️ Eliminate last-minute fire drills The most innovative companies aren't just compliant – they've made compliance a competitive advantage. Where does your organization stand?

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.

Quality Management and Compliance Consulting 101 In the past decade, I have worked extensively in quality assurance consulting with life science companies, helping them achieve regulatory excellence. And I use the same 5 techniques every time: Technique #1: Regulatory Gap Analysis How it works: • Assessment of current processes and procedures • Compare existing practices with regulatory requirements • Develop an action plan to address identified gaps This systematic technique allows you to align your operations with regulatory standards and mitigate compliance risks. ----- Technique #2: Document Control Optimization How it works: • Improve document management processes/systems • Implement version control and document writing guides • Properly approve, distribute, and archive documents Quick note: Don't overlook the importance of document management. It's the easiest technique and often the most neglected. You'll thank me later if you set the ground rules from the start. ----- Technique #3: Training and Competency Development How it works: • Determine job-related and regulatory training needs • Create targeted training programs and materials • Develop a competency assessment framework for employees (NOT a quiz with 3 attempts! 🤣 ) Invest in training. Your employees will be more productive, compliance awareness will be increased, and quality will be fostered. ----- Technique #4: Risk Management Implementation How it works: • Identify potential risks and hazards within your processes • Assess the likelihood and impact of each risk • Implement proactive controls + risk mitigation strategies Risk management minimizes quality incidents, ensures patient safety, and meets regulatory requirements. Don't go overboard with risk assessments. Be practical with the best information you have at the time. Get over the idea that you can 100% eliminate all risks. ------ Technique #5: Continuous Improvement Initiatives How it works: • Inspire continuous improvement and innovation • Make QA projects more engaging for employees • Keep an eye on KPIs and take action when necessary Continuous improvement will enhance operational excellence, resource utilization, and customer satisfaction. ------ That’s it! Here's a recap of the 5 techniques: 1- Regulatory Gap Analysis 2- Document Control Optimization 3- Training and Competency Development 4- Risk Management Implementation 5- Continuous Improvement Let me know which one of these techniques you found most helpful in the comments. Happy to do another post going into more depth on whichever technique you find most interesting.

Three Tips For Policies & Change Management Compliance (and other) policies often require changes in human behavior, but a policy alone is not likely to change behaviors. Policies therefore need to be preceded and accompanied by a proportionate amount of well thought and effective change management to help people understand what the changes are and why, and to ensure the change is lasting. Whether the change required is incremental or transformational, the change process should not be overlooked. Here are three tips for managing the change management process when it comes to policies: 1. Understand The Status Quo: In order to know how much change management is required, you need to understand how the desired behaviors compare to the status quo. This includes understanding current behaviors, asking why those behaviors exist and looking at the context that supports/expects the current behaviors (e.g., incentives). 2. Stakeholder Engagement Before The Policy Is Final: Training and awareness/communications are needed once the policy has been finalized, but that should not be the first point of stakeholder engagement. Engage different stakeholders (including those who will be impacted by the policy, leaders and managers, and anyone who will play a governance/oversight role for the policy requirements) early in the policy development process - ask them questions, hear their perspectives, and get them to help identify potential change management challenges you might not have considered. While time consuming, this can help start the change management process before the policy is even written, and engaged and informed stakeholders who helped to develop the policy might be more inclined to advocate for the policy once it is rolled out and help others with any necessary change management too. 3. Policies Are Products: You won’t see the Sales & Marketing Department launch a new product and think that sending an email or two to target audiences is enough. They will engage in a whole communication and awareness campaign to connect with and educate the target audiences, speak to them in terms of their interests, identify spokespeople or influential voices who can help engage and persuade others, and do so multiple times knowing that this type of change management will help the product’s success. Policies are essentially our products - if you want the policy to be successful, don’t think a single reference on an intranet site or email is going to support the necessary change management. What other tactics or approaches have others used to help support effective change management when it comes to policies? _____ #SundayMorningComplianceTip #EthicsAndComplianceForHumans 📚 Want to get more compliance ideas and suggestions like this? Connect with me here on LinkedIn or get your copy of my book called Ethics & Compliance For Humans (published by CCI Press and available in print and kindle format on Amazon and various other online book stores)