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Using Laserfiche for CAPA Compliance (Part Two)

In a previous post, we discussed how Laserfiche could be used for CAPA compliance. Hold onto your hats because we've got a few more methods that we explore below:

  • Use Laserfiche to support the investigation of the root causes of quality problems- It's not enough to identify problems; the actual investigation must be detailed in search of root causes. The organizations' SOPs (which should be stored in Laserfiche) include a systemic, documented methodology to implement when issues occur. A typical CAPA investigation could be automated using Laserfiche Workflow and Forms to ensure procedures are followed precisely. Adding some flexibility as to assigning a close date considers risk. The audit trail can be used to detail complex processes.

A CAPA investigation is composed of the following steps:

  • Writing a descriptive problem statement.

  • Implement the documented investigation procedure and conduct a thorough evaluation

  • Create documentation during the investigation

  • Uncover and analyze root cause(s). Identify the actions needed to correct and prevent a recurrence.

  • Validate CAPAs for effectiveness and prevent possible adverse impacts on the products- When the CAPA investigation is finished, any corrective or preventive actions in question should be tested to ensure the problems are solved. No new issues arise as a result of the action. In particular, changes to product production should be carefully investigated. Documentation of the validation should be stored in Laserfiche.

  • Implement and note changes in SOPs as a part of the Actions Taken. These changes must be distributed to Records Management and QA teams. Additionally, changes to procedures need to be reviewed by QA and management before adding to your SOPs. The review process can be automated with Laserfiche Workflow. If leadership is unaware of quality issues, it's a clear indicator to investigators that quality control is not being reviewed as frequently as it should. Regulators underscore the importance of management review by instructing investigators to look at the review schedule to determine if management reviews are sufficiently frequent enough to keep management "informed of ongoing quality issues and problems." However, periodic management reviews are not enough to be considered compliant; The CAPA follow-up report should document the investigations, list the actions taken, and validate these actions. These activities exist in a folder in Laserfiche for easy collaboration and versioning.

Overall, a CAPA system is effective when it includes procedures for analyzing quality data, offers a thorough investigatory procedure, validates the effectiveness of actions taken, records changes in methods and practices, and communicates that information to those involved in maintaining a compliant state. Compliance is too essential to exist in shared drives, emails, and desktops. A robust system, purpose-built to track activities and versions, automate collaboration and approvals, and provide an audit trail, is necessary for achieving and maintaining compliant status.



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