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Final Draft Data Management and Record Keeping Standard Operating Procedure

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40 views5 pages

Final Draft Data Management and Record Keeping Standard Operating Procedure

Uploaded by

anisamaponga
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Data Management and

Record Keeping
Doc. No.: Rev. No.:
Effective Date: Page: 1 of 5

Written by: A. Maponga Approved by:

1.0 TITLE
Data Management and Record Keeping Standard Operating Procedure

2.0 PURPOSE
2.1 To establish a standardized procedure for the accurate and secure management of
laboratory data, test results, and related records.
2.2 To ensure compliance with the requirements of the ISO 17025 standard for quality
management in testing and calibration laboratories.
2.3 To support;
 Records Management;
 Data Protection;
 Information Security;
 Protection of Vulnerable Groups

3.0 RESPONSIBILITIES
Medical Research Officer
Medical Laboratory Technologist/Scientist
Medical Laboratory Technician
Environmental Health Officer/Technician

4.0 EQUIPMENT AND SUPPLIES


4.1 Computers and software for data entry, analysis, and storage
4.2 Secure data storage devices (e.g., servers, external hard drives)
4.3 Logbooks, forms, and other physical record-keeping materials

5.0 PROCEDURE
5.1 Data Recording
5.1.1 All laboratory data, test results, and observations shall be recorded in a timely and
accurate manner in a designated Logbook.
Data Management and
Record Keeping
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5.1.2 Handwritten records must be legible, with any corrections made by drawing a single
line through the original entry and initialling and dating the change.
5.1.3 Electronic data shall be backed up regularly and stored in a secure location.
For Handwritten Records:

For Logbooks:
Each logbook should have a unique identifier (e.g., Logbook #001, Logbook #002).
Each page or entry should be sequentially numbered.
The logbook should have a table of contents or index at the beginning, listing the page
numbers and a brief description of the contents.
Entries should be dated, and the author should initial or sign each page.
Sample/Experiment Records:
Each sample or experiment should be assigned a unique identifier (e.g., Sample ID,
Experiment #).
A sample/experiment record form should be used to document all relevant information, such
as date, personnel, methods, observations, and results.
The sample/experiment records should be organized in chronological order or by the unique
identifier in a dedicated filing system.
An index or catalog should be maintained, listing the unique identifiers and corresponding
location of the physical records.
For Electronic Data:

File Naming Convention:


Files should be named using a standardized convention that includes relevant information,
such as the date, experiment/sample ID, and a brief description.
Example: "2024-05-07_Exp123_Protein_Assay.xlsx"
Directory Structure:
Electronic data should be organized in a hierarchical directory structure, with top-level
folders for broad categories (e.g., Experiments, Analyses, Instrumentation) and subfolders for
more specific data types or projects.
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Record Keeping
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An index or catalog of the directory structure should be maintained, either in a spreadsheet or


a dedicated document management system.
Metadata:
Electronic files should include relevant metadata, such as file creation and modification dates,
author/owner, and a brief description of the contents.
Metadata can be included in the file properties or recorded in a separate catalog or database.
Database or Document Management System:
For large or complex datasets, a database or document management system can be used to
centralize and index the electronic records.
These systems often provide advanced search and retrieval capabilities, version control, and
access management features.

5.2 Data Storage and Archiving


5.2.1 All records, both physical and electronic, shall be stored in a secure and organized
manner to prevent unauthorized access, damage, or loss.
5.2.2 Physical records shall be maintained in designated filing cabinets or storage areas.
5.2.3 Electronic data shall be stored on secured servers or other approved storage devices
with appropriate access controls.
5.2.4 Records shall be archived for a minimum of 5 years, or as required by regulatory or
accreditation bodies.

5.3 Data Retrieval and Review


5.3.1 A system for indexing and cataloguing records shall be maintained to facilitate the easy
retrieval of information.
5.3.2 Periodic reviews of the data management system shall be conducted to ensure the
integrity and completeness of the records.
5.3.3 Any issues or discrepancies identified during the review process shall be addressed and
documented.

5.4 Confidentiality and Security


Data Management and
Record Keeping
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5.4.1 Access to laboratory records, both physical and electronic, shall be restricted to
authorized personnel only.
5.4.2 Appropriate measures, such as password protection and data encryption, shall be
implemented to protect the confidentiality of the information.
5.4.3 Procedures for the secure disposal of confidential records shall be established and
followed.

6.0 TRAINING
6.1 All laboratory personnel shall receive training on this SOP and the data management and
record-keeping requirements.
6.2 Refresher training shall be provided periodically to ensure continued compliance with the
established procedures.

7.0 QUALITY ASSURANCE


7.1 The data management and record-keeping system shall be regularly audited to verify its
effectiveness and compliance with the ISO 17025 standard.
7.2 Any non-conformities or opportunities for improvement identified during the audit
process shall be addressed and documented.

8.0 RELATED DOCUMENTS


8.1 ISO 17025 Standard
8.2 Laboratory Quality Assurance Manual
8.3 Information Technology Security Policy

9.0 APPENDICES
9.1 Data Management and Record Keeping Audit Checklist

This SOP outlines the key elements of a comprehensive data management and record-keeping
system for a laboratory, aligning with the requirements of the ISO 17025 standard. It covers
the procedures for data recording, storage, retrieval, and security, as well as the roles and
Data Management and
Record Keeping
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responsibilities of laboratory personnel. The appendix includes a sample audit checklist to


verify the effectiveness of the implemented system. Let me know if you have any further
questions or need additional modifications.

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