A frequent and high-impact citation is around Document Control and Data Integrity. The FDA wants to see reliable and accurate records that haven't been manipulated or deleted. They look for audit trails that are computer-generated, time-stamped, and have no gaps in compliance with 21 CFR Part 11.
Paper records go missing. Spreadsheets proliferate, with no good way to track who’s making edits, and when. Shared drives are good for sharing, but not so good for controlling access and preventing deletions.
A centralized repository with controlled permissions gives you login-based access control. Automatic author-stamps and date-stamps are applied to records without human intervention, for data integrity compliance.
Another frequent citation: When things go wrong, such as deviations, complaints, recalls, or adverse events and the FDA expect to see rigorous tracking and response.
Most SME manufacturers struggle to establish robust systems for receiving, reviewing, and evaluating an issue when things go wrong. Collecting and tracking reports of issues on paper is an invitation for records to get misplaced. And manual methods don’t give you a mechanism to ensure consistent followup, escalation and resolution for every event.
Cost-effective and simple FDA software gives your team a way to directly report issues into a central repository, and automatically notify, escalate, and follow up on every issue. You’ll be able to generate reports for an FDA inspector on the fly, showing your response and progresson every incident and issue.
FDA inspectors also want to see that you have an effective CAPA System (Corrective Action/Preventive Action) system in place.
Inspectors won't just check for resolution of every issue and adverse event: they will look for proof that you performed a Root Cause Analysis and have a formal process to implement corrections and prevent recurrences. SME manufacturers try to cobble together a disparate patchwork of emails, Excel files, and calendar reminders, but this becomes unwieldy when an inspection team shows up.
Use a simple, user-friendly online system to handle all incidents, events and issues in one place. Follow them through with corrective and preventive action reminders, escalation, and reports, all triggered automatically. You'll have instant access to the CAPA records the FDA inspector wants to see.
Training records are among the most common FDA citations: you must prove that every production employee has received documented training on relevant and up to date SOPs and safety protocols. They’ll pull line workers off the line and check: do they know their CCPs, for example?
In high-turnover SME manufacturing facilities, maintaining detailed training records in real-time is a never-ending burden. The training content, scheduling, delivery, and testing all must be done on time, tracked, and audit-trailed.
You don’t need a 5-figure Learning Management System. You need a simple online, one-stop shop for your training records, courses, quizzes, and schedules, that makes sure all records are saved and tracked automatically. Add in automated reminders and prompts, and you’ll have FDA-ready proof that you’re on top of your training.
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