For researchers working in a regulated laboratory environment, preparing for an audit can be a daunting task. This is especially true if your records, staff training and SOPs have been neglected for a long period of time. Trying to play “catch up” once you learn about an impending audit will almost always be a losing proposition. Once you learn about an upcoming audit it will help to first understand the scope and depth of the audit. This will help you prepare your materials and allocate time and resources. However, the best way to prepare for a lab audit is to always be ready for an audit.
Tips for the “audit-ready” laboratory:
- Make sure your Standard Operating Procedures are up-to-date.
In order to understand how your lab is processing samples or collecting data, the auditor will be looking for clear SOPs that accurately describe the work in the lab. In general, once SOPs are created, they should be reviewed each year by people doing the work – and edited and versioned appropriately. Keeping your SOPs accessible and accurate will make preparing for an audit less stressful. If you have created corresponding lab workflows, you should also make sure that these accurately reflect your documented procedures.
- Ensure staff training records are up-to-date, complete and easily accessible. Auditors will check that the staff performing work in the lab are competently trained in the work they are performing. Keep accurate records of staff training and make sure that staff are getting regular refreshers as lab processes are updated.
- Have audit-ready sample records.
This can be challenging if your lab doesn’t follow standard procedures for record-keeping, or if your sample management software isn’t already doing this for you. If you’re not sure if your sample management system keeps audit-ready records, start by asking yourself- “If I picked a sample at random, would I be able to identify everything that happened to this sample?” Follow the “Who/What/When” approach – who performed that on what sample when? Sometimes the answer may be yes, but it could be a jumble of assorted records spread between notebooks and electronic systems. If you can’t establish the chain of custody easily and quickly, it may be time to reconsider your sample management system.
LabKey Sample Manager makes complete sample records and chain-of-custody easy to access with our Timeline feature. Timeline shows the complete chain of events for an individual sample from initial registration, to metadata/status updates, all storage events, related assay data and addition of samples to a workflow job.