What are the best practices for managing and storing quality records electronically?

1 Define your quality records

The first step is to define what constitutes a quality record in your organization, and how it differs from other types of documents or data. A quality record is any evidence that shows the results of a quality-related activity, such as an audit, a test, a corrective action, or a customer feedback. A quality record should be identifiable, traceable, and verifiable, and should comply with the requirements of your QMS and any applicable regulations or standards. You should also establish a list or a matrix of your quality records, indicating their origin, format, owner, location, and retention period.

2 Choose a suitable electronic system

Choosing an electronic system to support your quality record management and storage needs is the next step. This can be a dedicated software, a cloud-based service, or a combination. The system should have secure access and encryption for confidentiality and integrity, backup and recovery options, search and retrieval functions, metadata and indexing capabilities, version control and audit trail functions, and retention and disposal policies to ensure compliance with legal and regulatory obligations. These features will help you easily access your quality records and track changes and history.

3 Implement a quality record control procedure

Implementing a quality record control procedure is the third step, which should define the roles and responsibilities, the processes, and the rules for managing and storing quality records electronically. This procedure should include how to create, capture, and classify quality records; store, protect, and preserve them; access, distribute, and share them; modify, update, and delete them; archive, retain, and dispose of them; as well as monitor, measure, and improve the quality record management and storage system.

4 Train and communicate with your staff

The fourth step is to train and communicate with your staff on the importance, benefits, and best practices of managing and storing quality records electronically. Make sure they are aware of the definition and scope of your records, the system and tools used, the procedure and guidelines followed, their roles and responsibilities, and the risks and consequences of not managing them properly. It is essential that they understand all these elements to ensure successful management and storage of your quality records.

5 Review and update your quality records regularly

The fifth step is to review and update your quality records regularly to ensure that they are accurate, complete, relevant, and current. You should also check that your quality records are consistent with your QMS objectives, policies, and procedures, and that they reflect the actual performance and improvement of your processes and products. You should also verify that your quality records are compliant with the applicable regulations and standards, and that they meet the expectations and needs of your customers and other stakeholders.

6 Audit and improve your quality record management and storage system

The sixth step is to audit and improve your quality record management and storage system periodically to evaluate its effectiveness, efficiency, and suitability. You should use internal and external audits, feedback, and metrics to identify the strengths and weaknesses of your system, and to determine the opportunities and actions for improvement. You should also implement corrective and preventive actions, and monitor their results and impacts on your system. You should also document and communicate your findings, recommendations, and improvements to your staff and other relevant parties.