Record Management

Important

This section should be included in SOPs where records are generated during the procedure.

The ‘Record management’ section of an SOP should detail the process for reviewing and authorising records produced as part of the procedure. Example records may include: audit logs, training logs, approval forms etc.

This section may include:

  • Record procedure: Outline the steps for preparing and authorising new records, including required documentation, approval processes, and communication channels.

  • Reporting format: Define the standard format for the record.

  • Responsibilities: Define who is responsible for each step of record management.

Example content:

🧬 Bioinformatics QC Procedure

Example content from a bioinformatics SOP outlining the procedure for assessing the quality of Illumina sequencing data prior to downstream bioinformatics analyses.

Record Management

For each sample included in a sequencing run, the bioinformatics QC pipeline automatically generates an entry in the AutoQC database. This database captures both run level and sample level QC metrics, along with each sample’s QC status (QC Pass or QC Fail) and its organism/workstream assignment (e.g. HIV, SARS CoV 2, TB, C. difficile etc.).

Initially, records are accessible only to bioinformaticians until authorised by the duty bioinformatician. During the authorisation process, duty bioinformaticians must document the reason for any samples failing QC.

Following authorisation, records are viewable to other users e.g. technical staff within the laboratory.

👩‍🔬 Staff Training Procedure

Example content from an SOP outlining a training procedure

Record Management

Training generates the following records:

  • Attendance list

  • Completed Training Form (Tell–Show–Do–Apply sections)

  • Competency assessment results

  • Feedback forms

  • Any supporting materials (e.g., screenshots from trainee outputs, if relevant)

Storage:

ISO-in-a-Box SharePoint → Training Records → [Training Topic Folder]

Retention:

Minimum of 2 years or per institutional policy.

🌌 Galaxy Training Procedure

Example content from a training SOP detailing the standardised procedure for training on the Galaxy platform

Record Management

The following record are generated as part of this procedure:

  1. Attendance list (signed or digital)

  2. Completed assessment results

  3. Certificates of completion

  4. Feedback summary report

All records must be stored on the advISO SharePoint → Training Records → Galaxy_TB_Workflow directory, with access restricted to the Training Coordinator, and Project Lead. All records must be retained for X years.

🧪 Laboratory Procedure
💻 Code Update & Review Procedure

This section is not relevant for a code update and review procedure as this procedure does not generate new records.

✅ Validation Procedure