Compliance with regulations is paramount to reliable business, and scientific research in particular. Audits verify that compliance is maintained in facilities. The ideal scenario for an institution is to be as prepared as possible for an audit. This eliminates additional stress, and ensures a smooth audit.
Preparing for Audits
When preparing for an audit, there are steps that you can take to make the process easier for everyone: for the inspectors, for your business, and for your employees. The first step is to make sure that inspection procedures are clear and easily understood, to avoid any confusion or complication. Train staff members to answer only the questions inspectors ask them. Staff should feel comfortable either answering a question, or alerting the inspector that they can find out an answer. The goal is not to answer quickly, but accurately.
Second, be audit ready by making essential documents and records accessible to inspectors. Inspections can take considerable time, so having all documentation readily available, makes for a more timely and efficient audit. One commonly used method for storing documentation is to use a binder. Materials collected in such a binder might include procedures for comment and change controls, how to handle complaints, charts and tables, and a quality manual, among others. Know where documents are, so that you do not waste the inspector’s time or yours by trying to look them up. The more organized these documents are, the more prepared you will be. Disorganization helps no one, and certainly not your business.
Third, to streamline the audit, make sure products such as marketing materials are labeled and easily found. Make sure all staff members know how to answer questions about products and processes, and the expectations that investigatory agencies have of your institution.
Fourth, to manage any product complaints, be sure someone is in charge of complaints and how to explain them to an auditor. This can be tailored depending up on whether or not the complaints are electronic or otherwise communicated to your organization. You might be asked about quite specific details such as names, products, when the complaint was received, and other issues.
A fifth step for audit readiness is to report all corrections and recalls. Be prepared to present evidence that such events were completed, or have documentation to explain why they might not be resolved. This is all part of risk management, and is absolutely essential in compliance.
All of these steps must be addressed, but they make less impact if they are not practiced. Therefore the sixth step might be the most important for enabling audit readiness: roleplaying an inspection. You would not expect a surgeon to operate or a soldier to go onto the battlefield without having gone through scenarios and training again and again, so that those tasks are second nature. Likewise, you must ensure that you and your staff have played your own role as inspectors: asking questions, finding gaps in readiness, and so on. Once this has been done, it would be wise to enlist someone outside your department to run through the mock inspection with you and your staff as well. Practice may not make perfect, but practice makes things much better: practice makes you audit-prepared.
Using Technology for Audit Readiness
Given the volume of potential data an institution may have that an inspector may peruse, in this era it often makes more sense to store documentation digitally. Qualer’s Lab Management Software provides this powerful capability. The Asset Compliance capabilities of Qualer give you asset management control. Stakeholders can communicate under one platform, making sure the right people are involved at the right time.
Qualer’s Lab Management Software gives you a Compliance Dashboard, enabling asset management in one place. You can view the current status of assets and any deadlines related to them, across your organization. You can take action on upcoming items, and remain in command of your business.
Qualer also overs a validation package with its Lab Management Software. This gives you compliance with 21 CFR Part 11 as soon as you join. Additionally, you can set up the software with Real Time Alerts with three levels of notifications. Such alerts contact vendors, facilities, and team members to let them know about service event due dates as far in advance as you require.
The Asset Documentation feature of Qualer’s Lab Management Software keeps all your documentation in once database. Pre-loaded Users Manuals, Technical Specifications, Data Sheets, Brochures, and Installation and Operation Procedures documents are readily accessible when and where you need them. Qualer also offers Change Control Management, so asset owners can manage changes to service information about their assets.
With Qualer’s powerful platforms, you can be prepared for audits. Audits help businesses control the quality of their process and products. Preparation, practice, documentation, and education all play roles in audit readiness. Make the audit process easier and more efficient for you and for inspectors. See how Qualer gives you complete audit readiness today.
Software: Lab Management Software, Calibration Management Software, Maintenance Management Software Facility Management Software