Standard Operating Procedure- SOP

Name of institution

Short Term Archiving ID Code:

Ap 23

Topic & Purpose: Review Period:

This procedure explains how to archive 1 year
documents for a short term

Location: Distribution:

Version number: Annex:

V 1.0 None

Written by:

Name(s), Date(s) and Signature(s) of the Author(s)

Reviewed by:

Name(s), Date(s) and Signature(s)

Authorized by:

Name, Date and Signature

Replaces the version:

Not applicable (1st version)

Changes to the last authorized version:

Not applicable (1st version)
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 23
3 procedure: Short
Term Archiving QM chapter: 13
Procedure

Short Term Archiving Procedure

Application...............................................................................................................2
Objective.................................................................................................................2
Definitions...............................................................................................................2
References..............................................................................................................2
Responsibilities.......................................................................................................2
Operating mode......................................................................................................2
Related documents.................................................................................................3

Application
This procedure ensures correct archiving of laboratory documents.

Objective
This procedure explains how to archive documents for a short term. It applies to
all documents and records, generated by the laboratory staff, the Quality
Committee, the Biosafety Committee and the Management Branch.

Definitions
Document: Information and its supporting medium; digital or physical.

Record: Document stating results achieved or providing evidence of activities

performed. Information captured on worksheets, forms and charts.

References
To be filled in if necessary

Responsibilities
The Quality Manager is responsible for overseeing the proper archiving of
documents and records.

Operating mode
1. The Quality Manager will be in charge of archiving. He will verify legal or
normative requirements for which documents and records are required to be kept
and retention time.

2. All logbooks and records should be placed into specific folders or binders and
archived every XXX time.
 The request forms must be stored for a minimum of XXX months (country
specific).
 The laboratory reports must be stored for a minimum of XXX years
(country specific).

3. All archived documents should:

2
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 23
3 procedure: Short
Term Archiving QM chapter: 13
Procedure

 be labeled with the date of archiving;

 remain legible, readily identifiable and retrievable.

4. A file system should be started to store and archive data in different

appropriate folders. Each folder will contain all documents and records of its
category.

5. Data will be referenced in the corresponding archiving logbook, and labeled

with appropriate structural and data collection information.

6. Invalid or obsolete documents and data may be archived separately for

historical reference or background knowledge preservation.

7. When an archived document is to be retrieved, the date and person retrieving

it will be noted in the archiving logbook. The replacement of the document will
also be logged.

8. After XXX years of short term archiving, documents with no legal value can be
discarded; the documents of legal value will be transported to XXX for long term
archiving (refer to SOP Long Term Archiving).

Related documents
SOP Long Term Archiving Ref XXX