Think of the last time you tracked a package online. You could see every step of its journey, from the warehouse to your front door. The Drug Supply Chain Security Act (DSCSA) applies a similar principle to something far more critical: prescription drugs. It creates a transparent, unbroken record that follows a product from the moment it’s made until it reaches the dispenser. This complete history is known as DSCSA chain of custody documentation. It’s how you prove a drug is authentic and has been handled correctly at every point. This guide breaks down what this documentation includes, who is responsible for it, and how to manage it effectively.
Key Takeaways
- Your Documentation Must Tell a Complete Story: Every product needs a clear, unbroken record of its journey. This means capturing the essential transaction information, history, and statements to create a verifiable chain of custody that proves authenticity and ensures compliance.
- Use Technology to Automate and Simplify: Manual tracking can’t keep up with the demands of unit-level serialization. A purpose-built ERP system is crucial for automating data capture, ensuring seamless communication with partners, and keeping your records organized and ready for an audit.
- Build Compliance into Your Daily Operations: DSCSA isn’t just about software; it’s about process. Solidify your strategy by creating clear Standard Operating Procedures (SOPs), investing in regular team training, and consistently verifying your trading partners to manage risk proactively.
What Is DSCSA Chain of Custody Documentation?
Think of the last time you tracked a package online. You could see every step of its journey, from the warehouse to your front door. DSCSA chain of custody documentation works on a similar principle, but for something far more critical: prescription drugs. It’s the complete, unbroken record that follows a drug product from the moment it’s made until it reaches the dispenser. The whole idea behind the Drug Supply Chain Security Act (DSCSA) is to create a transparent trail. This allows anyone in the supply chain to trace a drug’s history and verify its legitimacy, making it much harder for counterfeit, stolen, or contaminated products to reach patients.
This documentation isn’t just a single form; it’s a collection of transaction information, history, and statements that are exchanged every time a drug changes hands. Each partner—from the manufacturer to the wholesale distributor to the pharmacy—is responsible for both providing and receiving this information. Maintaining these records accurately is the foundation of DSCSA compliance. It’s how you prove that your products are authentic and have been handled correctly at every point in their journey. Without this paper trail, there’s no way to verify a product’s origin or safety.
What Are the Core DSCSA Requirements?
To build that secure chain of custody, the DSCSA outlines a few key requirements that all trading partners must follow. First is serialization, which means assigning a unique product identifier—like a serial number—to each individual drug package. This allows for traceability at the unit level. Next is verification, the process of confirming that your trading partners are authorized and that the product identifiers are legitimate. Finally, all of this information must be shared through an interoperable electronic system, meaning your software needs to communicate seamlessly with your partners’ systems. Meeting these core requirements is essential for full DSCSA compliance.
Why Documentation Compliance Matters
Staying on top of your documentation isn’t just about checking a box for the FDA. It’s about protecting your business and, most importantly, the patients who rely on your products. Failing to comply can lead to serious consequences, including hefty fines, shipment delays, and even the loss of your license. If you work with partners who aren’t compliant, you put your entire operation at risk of supply chain disruptions and intense regulatory scrutiny. Beyond the penalties, strong documentation practices are a critical tool in public health efforts, including the fight against the opioid crisis, by ensuring that only safe, legitimate medications are in circulation.
What Belongs in Your DSCSA Documentation?
Think of your DSCSA documentation as a product’s passport. It’s a complete, verifiable record that travels with a drug at every step, proving its identity and legitimacy. Getting this documentation right isn’t just about checking a box; it’s about ensuring patient safety and protecting your business. The FDA requires specific pieces of information to be captured and shared with every change of ownership. Let’s break down exactly what you need to include.
Key Transaction Information
At the heart of DSCSA documentation are the “3Ts”: Transaction Information, Transaction History, and a Transaction Statement. Transaction Information (TI) is the basic who, what, and when of the exchange. It includes the product name, strength, and dosage form, its National Drug Code (NDC), container size, the number of containers, the transaction date, and the names and addresses of the company selling the product and the one buying it.
The Transaction Statement is an attestation from the seller that they are an authorized trading partner, have received the product from an authorized partner, and have the correct transaction information. Essentially, you’re confirming the legitimacy of everyone involved. To meet these requirements, all partners in your supply chain must be properly licensed and registered. Working with a system that helps you manage and verify your partners is a critical part of maintaining compliance.
Product Identifiers and Serialization
This is where we get down to the individual package level. Every prescription drug package and case must have a unique product identifier (PI) that acts like a fingerprint. This PI includes the product’s NDC, a unique serial number, the lot number, and the expiration date. It needs to be both human-readable and encoded in a 2D data matrix barcode.
Under DSCSA, each trading partner’s responsibility is often described as “one-up, one-back.” This means you must be able to verify that the shipment and its documentation came from a legitimate, authorized source and provide that same verifiable information to the next partner in the chain. A serialized ERP system is designed to handle this automatically, capturing and verifying each unique identifier as products move through your operations, which is far more reliable than manual tracking.
How to Store and Access Your Documents
Collecting all this information is only half the battle; you also need to store it correctly. The DSCSA requires you to keep all transaction records for six years from the date of the transaction. And these records can’t just be filed away in a dusty cabinet—they must be easily accessible and retrievable. If the FDA or a state agency requests your documentation during an audit or investigation, you need to be able to produce it promptly.
Failing to do so can lead to serious consequences. Companies that engage with unverified partners or have incomplete records risk fines, supply chain disruptions, and intense regulatory scrutiny. This is why spreadsheets and paper systems just don’t cut it. An integrated system with strong inventory management and reporting capabilities ensures your data is secure, organized, and ready whenever you need it.
Who Is Responsible for What?
The Drug Supply Chain Security Act (DSCSA) treats the pharmaceutical supply chain like a relay race. Each trading partner has a specific role in carrying the baton of documentation forward to ensure products are traceable and legitimate from start to finish. Whether you’re a manufacturer, distributor, or dispenser, you have unique responsibilities for creating, maintaining, and passing along chain of custody information.
Understanding your specific duties is the first step toward solidifying your compliance strategy. When every partner handles their part correctly, the entire system works to protect patient safety and maintain the integrity of the drug supply. Let’s break down what’s expected at each stage of the journey.
For Manufacturers
As a manufacturer, you’re at the starting line. Your primary responsibility is to embed traceability into your products from the very beginning through unit-level serialization. This means retooling production lines to handle more complex barcode packaging, labeling, and inspection processes. You are required to affix a unique product identifier to each package and homogenous case of a product. Beyond the physical packaging, you also have to manage the massive volumes of data that come with serialization. You need a robust system to store this information and make it accessible to your supply chain partners and the FDA for any verification requests. A serialized ERP is essential for managing this complexity without slowing down your operations.
For Wholesale Distributors
If manufacturers start the race, wholesale distributors run the middle leg. Your core responsibility is to maintain the chain of custody documentation as products move between the manufacturer and the dispenser. For every transaction, you must provide your trading partners with the required Transaction Information (TI) and Transaction Statement (TS). The challenge here is doing this through secure, electronic, and interoperable systems. Many distributors run into trouble when trying to share and verify drug data electronically, especially when dealing with multiple partners who may use different systems. Your role is to ensure the data you receive is accurate and that you pass it along seamlessly, confirming the legitimacy of every product that moves through your facility.
For Dispensers
As a dispenser, you’re the final checkpoint before a medication reaches the patient. Your most critical DSCSA responsibility is to confirm that you are sourcing products only from authorized trading partners (ATPs). Before accepting a shipment, you must verify the product identifiers and ensure the documentation is complete and accurate. Engaging with unverified or non-compliant partners isn’t just a paperwork error—it can lead to severe penalties, disrupt your supply, and put your patients at risk. Your diligence is what makes the entire traceability system effective, ensuring that only safe and authentic medications are given to consumers. This makes strong compliance tools an indispensable part of your workflow.
How to Verify Trading Partners
Verifying your trading partners is a non-negotiable part of DSCSA compliance for everyone in the supply chain. So, how do you do it? The process involves confirming that your partners are properly licensed and registered. To meet ATP verification requirements, manufacturers and repackagers must be registered with the FDA. For wholesale distributors and third-party logistics providers (3PLs), you’ll need to confirm they hold valid state and federal distribution licenses. It’s a fundamental step in due diligence that protects your business and upholds the security of the entire pharmaceutical supply chain. Regularly checking these credentials should be a standard part of your operating procedures.
Overcome Common Documentation Hurdles
Meeting DSCSA documentation requirements can feel like a major undertaking, but you’re not alone in facing these challenges. Most hurdles in the pharmaceutical supply chain come down to a few key areas: managing massive amounts of data, getting different systems to communicate, training your team, and maintaining strict quality control. By understanding these common pain points, you can create a clear strategy to handle them effectively. Let’s break down each one and explore some practical solutions.
Managing Your Data
The shift to unit-level serialization means you’re suddenly dealing with a huge volume of data. Every single package has a unique identifier, and its entire journey must be tracked and documented. The core of DSCSA compliance rests on your ability to manage this data for traceability, verification, and investigations. Without a robust system, it’s easy to get overwhelmed. The key is to have a centralized platform that can handle the scale and complexity of this information, ensuring every transaction is accurately recorded and easily accessible. A purpose-built serialized ERP is designed to manage this data flow, turning a potential compliance headache into a streamlined, automated process.
Ensuring System Interoperability
Your products move through multiple hands before reaching the patient, from manufacturers to distributors to dispensers. The problem is, each trading partner might use a different system for tracking. When these systems don’t talk to each other, you get data silos and a broken chain of custody. This lack of end-to-end visibility is a major compliance risk. True interoperability means your systems can seamlessly exchange data with your partners’ systems, creating a single, unbroken record for every product. An integrated platform eliminates the need to patch together different solutions, ensuring everyone in your supply chain is working from the same source of truth and maintaining a secure flow of information.
Training Your Team
Your documentation is only as good as the people managing it. Regulatory compliance is a team effort, and it requires everyone, from the warehouse floor to the executive office, to understand their role. One of the biggest hurdles is ensuring your staff is properly trained on procedures and the systems they use. Complex, clunky software can lead to human error, which can put your compliance at risk. The solution is to invest in ongoing training and adopt user-friendly technology. Systems with intuitive interfaces and helpful tools, like an integrated AI Chat for quick questions, can make the process much smoother and empower your team to maintain compliance confidently.
Implementing Quality Control
For manufacturers, DSCSA compliance starts on the production line. The process of applying unique barcodes, labeling packages, and inspecting every unit requires incredible precision. Any error at this early stage—a misprinted label or a bad scan—can cause significant problems down the line. Storing and standardizing these massive data volumes also requires strict quality control to ensure accuracy. Your systems need built-in checks and balances to catch errors before they become major issues. Strong inventory management and quality assurance protocols are not just best practices; they are essential for creating reliable documentation from the very beginning of the supply chain.
How Technology Simplifies DSCSA Compliance
Meeting DSCSA requirements can feel like a monumental task, but you don’t have to manage it with spreadsheets and manual processes. The right technology transforms compliance from a complex burden into a streamlined, automated part of your operations. Instead of just checking boxes, you can build a more secure, transparent, and efficient supply chain. Modern solutions are designed to handle the heavy lifting of data management and traceability, giving your team the tools to maintain flawless documentation with far less effort. By embracing these advancements, you not only ensure you meet federal law but also gain valuable insights that can strengthen your entire business.
Automated Tracking Systems
Unit-level serialization is a major hurdle for manufacturers, requiring complex changes to packaging, labeling, and data storage. This is where automated tracking systems come in. A purpose-built serialized ERP handles the complexities of managing unique product identifiers from the production line to the final dispenser. These systems automate data capture and storage, which drastically reduces the risk of human error. This ensures your information is always accessible for verification by trading partners and the FDA, simplifying one of the toughest parts of compliance.
Integrated Data Solutions
Your DSCSA data is more than a compliance requirement; it’s a strategic asset. An integrated data solution turns this information into a powerful tool for growth. By unifying your operational, commercial, and compliance data, you get a complete view of your supply chain. This allows you to use business intelligence analytics to gain valuable insights into product distribution and market trends, as noted by industry experts at IQVIA. You can spot inefficiencies and make smarter decisions, turning a regulatory task into a competitive advantage.
The Role of Blockchain
Blockchain technology enhances security and trust in the supply chain. It acts as a shared, unchangeable digital ledger that all trading partners can verify, creating a transparent and tamper-proof record of every transaction. This helps to “illuminate an otherwise dark supply chain,” as PharmExec puts it. By providing a single source of truth for product custody, blockchain is a powerful tool for preventing counterfeit drugs from entering the market. It makes tracing products back to their source instant and reliable, building a more secure system for everyone involved.
Real-Time Monitoring
In a complex supply chain, visibility is everything. Real-time monitoring systems give you crucial oversight, ensuring you know where your products are at all times. With a connected system, you can track products as they move between partners and get instant alerts for potential issues, like a verification request or a suspect product investigation. This proactive approach helps your team resolve problems quickly and maintain a smooth flow of operations. It allows you to confidently demonstrate your compliance at any moment, keeping your business on track and secure.
Best Practices for Flawless Documentation
Staying on top of DSCSA documentation can feel like a huge task, but it doesn’t have to be a source of stress. The key is to move from a reactive mindset to a proactive one. Instead of scrambling to fix errors, you can build a system that prevents them from happening in the first place. This is about more than just meeting regulatory requirements; it’s about creating a smooth, reliable, and transparent supply chain that protects both your business and the patients you serve.
Think of these best practices as the foundation of your compliance strategy. They create consistency, clarity, and accountability for everyone on your team and across your network of trading partners. By implementing clear procedures and quality checks, you turn compliance into a routine part of your daily operations. This not only reduces the risk of costly penalties but also strengthens your relationships with partners who can trust that you have your processes locked down. A solid documentation system is a powerful asset, giving you the confidence to handle audits and the agility to adapt to future changes in regulation.
Create Standard Operating Procedures (SOPs)
Your first step is to create and implement comprehensive Standard Operating Procedures (SOPs) for every logistics process. SOPs are detailed, written instructions that explain exactly how to perform a specific task, ensuring everyone on your team does it the same way, every time. This consistency is crucial for maintaining quality and compliance. Your SOPs should cover everything from receiving and inspecting a shipment to verifying transaction data and transferring ownership. By documenting these steps, you eliminate guesswork and create a clear, trainable process that reduces the chance of human error. Think of it as your company’s playbook for DSCSA documentation.
Set Clear Record-Keeping Guidelines
Once you have your procedures down, you need clear rules for managing the records you generate. Establish firm guidelines for how long transaction data must be stored (the DSCSA requires six years), where it will be kept, and who has access to it. Your system should allow you to retrieve any record quickly and easily in the event of an audit or an investigation. Using a platform with strong business intelligence analytics can help you organize and access this information efficiently. A well-defined record-keeping policy ensures your data is secure, accessible, and always ready for inspection, providing a complete and defensible history of every product.
Implement Quality Assurance
Quality assurance is your safety net. Under DSCSA, each trading partner has a “one-up, one-back” responsibility, meaning you must verify that the shipment and its documentation came from a verified source and are 100% accurate. This check should be a non-negotiable part of your process for every single transaction. Before accepting a shipment, your team should confirm that the product identifiers on the package match the electronic data. A robust serialized ERP system automates much of this verification, making it easier to catch discrepancies before they become bigger problems and ensuring the integrity of the products moving through your facility.
Verify Your Compliance Methods
DSCSA compliance is a team sport—your own flawless documentation isn’t enough if your partners aren’t holding up their end. Engaging with unverified or non-compliant trading partners can expose you to severe penalties and major supply chain disruptions. Before entering into a new partnership, do your due diligence. Verify their licenses and confirm they have the systems in place to securely exchange transaction data. Regularly checking that your partners are authorized trading partners is a critical step in protecting your business and the entire supply chain. This ensures everyone you work with is committed to the same high standards of safety and compliance.
How to Manage Compliance Risk
Staying compliant with the DSCSA isn’t just about checking boxes; it’s about actively managing risk to protect your business and the patients you serve. A proactive approach helps you catch potential issues before they become costly problems. By building strong processes and using the right tools, you can handle compliance with confidence, turning a complex requirement into a streamlined part of your daily operations. This means fewer surprises, smoother audits, and a more secure supply chain for everyone involved.
Prevent Errors Proactively
The best way to manage compliance risk is to prevent errors from happening in the first place. Under the DSCSA, your core responsibility is “one-up, one-back”—verifying that every product you receive comes from a legitimate trading partner and that you pass accurate data to the next partner in the chain. Manually checking every shipment and its documentation is time-consuming and leaves room for human error. A robust serialized ERP system automates this verification process. It ensures the data is complete and accurate and confirms that ownership changes are correctly reported. By building these checks directly into your workflow, you can proactively catch discrepancies and maintain a clean, compliant chain of custody from the start.
Monitor Your Compliance
DSCSA compliance is an ongoing process, not a one-time project. Regulations can evolve, and your internal processes need to keep pace. Regularly monitoring your compliance status is essential for identifying gaps before they lead to bigger issues. Think of it as a routine health check for your operations. Using built-in compliance tools can help you stay on top of serialization and drug tracing requirements without constant manual oversight. These systems can flag exceptions, track transaction histories, and generate reports that give you a clear view of your compliance posture at any given moment. This continuous monitoring ensures you’re always ready for what’s next and can adapt quickly to any changes in the regulatory landscape.
Prepare for Audits
Audits are a standard part of operating in the pharmaceutical industry. With the right preparation, they can be a smooth and straightforward process. The key is having organized, easily accessible documentation. When an auditor asks for specific transaction histories or proof of verification, you need to be able to provide it quickly. Engaging with unverified or non-compliant trading partners can lead to severe penalties and disruptions, making partner verification a critical part of your audit readiness. An integrated system that allows you to easily generate reports and pull complete audit trails is your best asset. It demonstrates that you have control over your supply chain and are serious about your compliance obligations.
Avoid Penalties
One of the biggest challenges for any pharmaceutical company is keeping up with changing regulations. Failing to meet DSCSA requirements can result in significant fines, product seizures, and damage to your company’s reputation. These penalties aren’t just financial—they can disrupt your entire supply chain and erode trust with your partners and customers. The most effective way to avoid these consequences is to embed compliance into your operational DNA. By leveraging technology designed specifically for the pharmaceutical supply chain, you create a safeguard that helps you adhere to federal and state rules. This proactive stance protects your business from penalties and reinforces your commitment to a safe and secure drug supply chain.
Get Ready for What’s Next in DSCSA
Meeting DSCSA requirements isn’t a one-and-done project. The regulations are designed to evolve, creating a more secure and transparent pharmaceutical supply chain for the future. Staying compliant means keeping an eye on what’s ahead and treating your documentation and tracking systems as living parts of your operation. It’s about building a framework that not only meets today’s rules but is also flexible enough to adapt to tomorrow’s challenges. By embracing this forward-looking approach, you can turn a regulatory requirement into a strategic advantage, ensuring your business remains resilient, efficient, and prepared for the next phase of supply chain security.
Upcoming System Requirements
The push for full interoperability marked a pivotal moment for the pharmaceutical industry. Now, the focus shifts from preparation to execution and refinement. Compliance hinges on mastering four key areas: serialization, data interoperability, product verification, and maintaining authorized trading partner (ATP) status. Your systems must be able to seamlessly exchange transaction data with every partner in your supply chain. This isn’t just about having the data; it’s about ensuring it can be sent, received, and understood electronically across different platforms. A robust serialized ERP is no longer a nice-to-have—it’s the foundation of your entire compliance strategy, enabling the secure, unit-level traceability that the DSCSA demands.
Integrating Future Technology
With the foundational elements of DSCSA in place, you can begin to integrate more advanced technology to strengthen your supply chain. The goal of the act was always to create a system where authorized partners could follow a drug’s complete chain of custody, making it easier to spot and stop counterfeit or substandard products from entering the market. This is where integrated solutions shine. Technology that combines traceability with business intelligence analytics can help you identify patterns, manage exceptions, and gain deeper insights into your operations. By looking beyond basic compliance, you can use these tools to build a more efficient, predictable, and secure supply chain.
Adopting Continuous Improvement
If regulations and standards were static, compliance would be a much simpler task. But the reality is that the pharmaceutical landscape is always changing. With DSCSA now fully enforced, it’s critical to treat compliance as an ongoing priority, not just a series of regulatory checkboxes. This means regularly reviewing your processes, updating your systems, and ensuring your team is trained on the latest requirements. Adopting a mindset of continuous improvement helps you proactively manage risk and maintain flawless documentation. A dedicated partner focused on compliance can help you stay ahead of changes and ensure your operations remain secure and efficient for the long haul.
Maintain Compliance for the Long Haul
Meeting DSCSA requirements isn’t a one-and-done task. Think of it as an ongoing commitment to maintaining the integrity of your supply chain and protecting patient safety. As regulations evolve and your business grows, your compliance strategy needs to adapt right along with it. Staying proactive is the key to avoiding last-minute scrambles and potential penalties. A long-term approach involves regularly checking your processes, keeping your technology current, and ensuring your team is always up to speed. By building these habits into your operations, you can turn compliance from a recurring headache into a seamless part of your workflow.
Regularly Review Your Documentation
One of the biggest hurdles in the pharmaceutical industry is keeping pace with changing state and federal regulations. What was compliant last year might not be sufficient today. That’s why it’s so important to review your documentation practices on a regular basis. Schedule time quarterly or semi-annually to go over your standard operating procedures (SOPs) and ensure they still align with the latest DSCSA guidance. Assigning a point person or a small team to monitor regulatory updates can help you stay ahead of changes. A solid system makes these reviews much simpler by keeping all your records organized and accessible, ensuring your compliance efforts are always based on current information.
Update and Maintain Your Systems
Your technology is the backbone of your DSCSA compliance efforts. The act’s core requirements—serialization, traceability, verification, and interoperability—all depend on robust systems that can handle complex data exchange. Regularly updating your software and hardware is non-negotiable. Work closely with your technology provider to ensure your platform evolves with regulatory milestones. A purpose-built serialized ERP is designed to handle these updates smoothly, unlike generic systems that often require complicated patches or workarounds. This isn’t just about software; it also means ensuring your scanners, printers, and other integrated hardware are functioning correctly to prevent data gaps and operational delays.
Invest in Ongoing Team Training
Compliance is a team sport, and every person who handles products has a role to play. It’s not enough for leadership to understand the rules; your staff on the warehouse floor, in accounting, and in quality control need to be just as knowledgeable. Investing in ongoing training empowers your team to meet complex requirements with confidence. Create a regular training schedule that covers DSCSA fundamentals, your specific SOPs, and any recent changes in procedure or regulation. When your team understands the why behind the rules—protecting patients from counterfeit drugs—they become your most valuable compliance asset. Modern tools with intuitive interfaces and AI chat features can also support day-to-day operations, making it easier for everyone to do their part correctly.
Related Articles
- Drug Supply Chain Security Act – Understanding DSCSA Compliance
- What Is DSCSA? – Drug Supply Chain Security Act (DSCSA)?
Frequently Asked Questions
What’s the most important part of the DSCSA documentation I need to get right? The most critical elements are what we call the “3Ts”—Transaction Information, Transaction History, and a Transaction Statement. Think of this as a product’s passport. It proves the product’s identity, shows every stop it has made on its journey, and includes a formal declaration that you and your partners are authorized to handle it. Getting this information right for every single transaction is the foundation of a compliant and defensible chain of custody.
How do I handle documentation if my trading partners all use different software? This is one of the most common hurdles, and it’s why interoperability is a core part of the DSCSA. When systems can’t communicate, you risk creating gaps in the product’s history. The solution is to use a platform designed to exchange data seamlessly with other systems in the supply chain. A purpose-built ERP acts as a universal translator, ensuring that the critical transaction data you send is the same data your partner receives, maintaining an unbroken and verifiable electronic record.
What does “one-up, one-back” mean in practice for my team? In simple terms, it means you are responsible for your link in the chain. For every product you receive, you must be able to verify it came from an authorized partner (“one-up”). For every product you send out, you must provide complete and accurate documentation to the next partner (“one-back”). In your daily operations, this means your team must have a reliable process for checking incoming shipments against their electronic data and for generating the correct documentation for outgoing orders.
We’re a smaller company. Do we really need a big, complex system for this? Compliance requirements are the same regardless of your company’s size, and the risks of non-compliance are just as serious. The goal isn’t to get a “big” system, but the right system. Trying to manage serialization data with spreadsheets or a generic ERP that isn’t built for pharmaceutical regulations often creates more work and a higher risk of error. A specialized platform automates these complex tasks, which can actually save a smaller team significant time and prevent costly mistakes.
How can I prepare my team for an audit without causing a panic? The best way to handle an audit is to make it a non-event. If you have strong daily processes, an audit is simply a chance to demonstrate your good work. This starts with having clear Standard Operating Procedures (SOPs) that everyone follows. It also means using a system where all your transaction records are organized, secure, and easily retrievable. When your team knows exactly where to find any piece of information an auditor asks for, it builds confidence and turns a stressful situation into a routine check-in.
