7.11 Control of Data and Information Management

The laboratory shall establish and maintain control over data and information management systems, ensuring data integrity, protection, validation, and compliance with applicable requirements.

7.11.1 Access to Data and Information

The laboratory shall have access to the data and information needed to perform laboratory activities.

7.11.2 Validation of Laboratory Information Management System(s)

The laboratory information management system(s) used for the collection, processing, recording, reporting, storage, or retrieval of data shall be validated for functionality, including the proper functioning of interfaces within the system, by the laboratory before introduction.

Whenever there are any changes, including laboratory software configuration or modifications to commercial off-the-shelf software, they shall be authorized, documented, and validated before implementation.

Note:

In this document, “laboratory information management system(s)” includes the management of data and information contained in both computerized and non-computerized systems. Some of the requirements may be more applicable to computerized systems than to non-computerized systems.

Note:

Commercial off-the-shelf software, in general use within its designed application range, can be considered to be sufficiently validated.

7.11.3 Requirements for Laboratory Information Management System(s)

The laboratory information management system(s) shall:

  1. be protected from unauthorized access;
  2. be safeguarded against tampering and loss;
  3. be operated in an environment that complies with provider or laboratory specifications or, in the case of non-computerized systems, provides conditions that safeguard the accuracy of manual recording and transcription;
  4. be maintained in a manner that ensures the integrity of the data and information;
  5. include recording system failures and the appropriate immediate and corrective actions.

7.11.4 External Management of Laboratory Information Systems

When a laboratory information management system is managed and maintained off-site or through an external provider, the laboratory shall ensure that the provider or operator of the system complies with all applicable requirements of this document.

7.11.5 Availability of System Instructions and Manuals

The laboratory shall ensure that instructions, manuals, and reference data relevant to the **laboratory information management system(s) are readily available** to personnel.

7.11.6 Checking of Calculations and Data Transfers

Calculations and data transfers shall be checked in an appropriate and systematic manner.