Purpose
To define the procedure for archiving laboratory documents in the QA department to ensure
proper storage, easy retrieval, and compliance with regulatory requirements.
2. Scope
This SOP applies to all QA laboratory documents, including but not limited to test reports, raw
data, calibration records, training records, and investigation reports.
3. Responsibility
3.1 Laboratory Personnel
Ensure that documents are complete, accurate, and signed before submission for
archiving.
3.2 QA Manager
Review and approve documents for archiving.
3.3 Archivist/Designated Personnel
Maintain the archive room.
Ensure documents are correctly stored, labeled, and retrievable.
4. Definitions
Archiving: Systematic storage of records for long-term preservation and retrieval.
Retention Period: The minimum duration for keeping documents as per regulatory or
organizational requirements.
5. Procedure
5.1 Preparation for Archiving
1. Ensure all documents are complete, accurate, and authorized.
2. Verify that the document does not require further immediate use.
3. Group documents by category, such as:
o Test Records
o Calibration Reports
o Training Records
o Investigations
5.2 Archiving Process
1. Labeling
o Assign a unique identification code to each document.
o Include the document name, category, date, and retention period on the label.
2. Storage
o Store documents in fire-resistant cabinets or designated archive rooms.
o Maintain proper environmental conditions (temperature and humidity).
o Keep electronic records in a validated document management system (if
applicable).
3. Indexing
o Record each document in an archive register or software system.
o Include details such as document title, ID, category, date of archiving, and
retention period.
4. Access Control
o Restrict access to authorized personnel only.
o Maintain an access log for all retrieved documents.
5.3 Retention Period
Follow the organization's retention policy and relevant regulatory guidelines (e.g., FDA,
EMA).
Typical retention period: 5–10 years, depending on document type.
5.4 Document Disposal
1. Identify documents due for disposal after the retention period.
2. Obtain approval from QA management before disposal.
3. Dispose of documents securely (e.g., shredding, incineration).
4. Record the disposal in the archive register.
6. Records
Archive Register (Document Index)
Access Log
Disposal Record
7. References
[Relevant regulatory guidelines, e.g., 21 CFR Part 11, ICH Q7, ISO 9001]
Organization’s Retention Policy
8. Annexures
Annex 1: Archive Register Template
Annex 2: Document Label Format
Annex 3: Access Log Template
Annex 4: Disposal Approval Form
