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How to Maintain an Audit-Ready State…and the Tools that Help

October 5, 2016 / by Emily Ysaguirre

The goal of many companies involved in thMaintaining_an_audit_ready_state.jpge Life Sciences world is to reach and maintain compliance with regulations set forth by agencies such as the FDA. Automated solutions help to achieve these goals and track compliance from beginning to end, while enabling systematic and objective decisions to be made.  

Some tools that help include:

Document Control: Document Control helps create document records, assign users keywords to records so they are easier to locate and enables users to attach files and documents of any size or type to be routed through document review and approval phases.

This ensures that changes to documents follow change procedures and processes. A big part of the Life Sciences industry is maintaining regulation toward standards like ISO 13485. Document Control solutions offer traceability into processes and total control over compliance with regulatory standards.

Employee Training: Information or standards that are changed within a Document Control system can be automatically routed through an Employee Training system. When updated, a record is sent through the Employee Training database to update and allow employees to re-train on so they remain knowledgeable on all processes and responsibilities. Employee Training offers automated tests to verify that training requirements are completed with a pass or fail grade. This helps not only to track the current status, but enables managers to oversee what documents and elements may need additional training to prevent potential adverse events.

Risk Management: Risk Management software tools allow users to handle adverse events systematically. The best way to take care of non-routine events is to identify trends in risk and take the initiative to mitigate the risk of said event and its recurrence. Risk Management should be incorporated within all processes to ensure a high level of compliance. With risk templates, employees are able to build a history of events and generate reports by various risks from all areas of business. This helps to create a macro-level view of risk across all processes and to take action before it’s too late.

The ability to initiate improvement lies in Risk Management’s partner, Corrective Action.

Corrective Action: Corrective Actions stem from the inherence of risk information and are automatically linked to the original assessment for clarification. This means that once an adverse event is detected through risk management it finds out all necessary information to put a stop to it. Once completed, Corrective Action software conducts investigations to find the root cause. The root cause allows for the correction process to be truly corrective to the process. Corrective Action solutions provide the ability to inherit data from an adverse event such as a complaint, audit, nonconformity or any other type of event and escalate the process for each corrective action using an intuitive, rules-based workflow.

Audit Management: Audit Management solutions guide users through the process of managing and tracking audits.  With these automated solutions, users can create configured workflows and audit profiles, enabling them to have all the components of their audit management system in one centralized location. Users can conduct scheduled audits or ad-hoc audits, add questions or checklists, and choose from variable scoring options.  With these capabilities, users can build a comprehensive audit management plan that tracks the progress of their auditing program, from start to finish and provides complete visibility into the overall effectiveness of the compliance system.

Driving regulatory compliance is critical to businesses. The FDA has placed significant oversight on the Life Science industry, so compliance is crucial to success.

Automated software solutions help create a state of compliance and preparation, ensuring that companies are always audit-ready.

Your guide to better document control

Topics: Life Sciences, Topics: Quality