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LabWare
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H20 vl.O.1

Record Retention Policy

Effective: 15 May 2017

Issued by 7
President

Approved by: d- V
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Quality M a ~
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Contents
1 Scope..............................................................................................................................4
2 Purpose...........................................................................................................................4
3 Roles ..............................................................................................................................4
4 Referenced Documents..................................................................................................4
5 Retention Policy.............................................................................................................4
5.1 Audit Room Documentation ................................................................................4
5.2 Electronic Archive and Storage............................................................................ 4
5.3 Electronic Archive and Storage............................................................................ 5
6 Disposal Policy.............................................................................................................. 5
7 Definitions...................................................................................................................... 5

Document Name: SOP H20 Record Retention Policy vi .0.1 E

Last Modified: 1 May 2017
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Change Control

Issue Change Control Effective Date

v1.0 New document based on changes to SOP structure to be global or regional 15 May 2017
in NA. SOP H20 previously SOP 6 v3.1.
vl.0.1 Corrected typo. 15 May 2017

SOP Owner
Quality Manager

Document Name: SOP H20 Record Retention Policy vi .0.1 Effective Date: 15 May 2017
Last Modified: 1 May 2017
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All paper files maintained within the LabWare office are evaluated to determine their
applicability to LabWare’s quality procedures or services delivery. If it is determined
that the file contains such documents, it is to be clearly labeled Retention Reviewable,
otherwise Exempt.
The remainder of this policy applies to all documents that are collected and stored as part
of the Lab Ware quality procedures or service delivery. This document does not further
regulate documents that are not specifically referenced within the quality procedures or
this document.

Fgii=
;,

The purpose of this document is to define Lab Ware’s record retention policy.

3 Roles
All Team Members

4 Referenced Documents
None

5 Retention Policy

5.1 Audit Room Documentation

All documentation itemized within the Audit Room Document Inventory are designated
as Lifetime retention. That means that these documents are to be maintained in printed
form or electronic form for the lifetime of Lab Ware Holdings (as per ASME NQA-1-
2000.)
In addition, all binders recorded on the Audit Room Document Inventory must be labeled
as Quality Documentation and designated as Lifetime Retention.

5.2 Electronic Archive and Storage

All electronic storage and archive of LabWare documentation, Vendor documentation,
and Customer (e.g., invoicing and payment records) documentation that LabWare
maintains possession of are to be retained on servers and machines within direct
Lab Ware control.
This includes back up of laptops, document sharing tools, storage of project deliverables.
However, if a system can demonstrate satisfactory security compliance through testing or
certification, then that system may be used for these purposes with document agreement
from the President of Lab Ware Holdings.
Document Name: SOP H20 Record Retention Policy vi .0.1 Effective Date: 15 May 2017
Last Modified: 1 May 2017
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5.3 Electronic Archive and Storage

The following list describes the record types and maximum or minimum retention time
for the document type:
Prospect records are maintained up to five (5) years [max] from the conclusion of
their selection process.
Customer records are maintained up to five (5) years [max] after discontinuation of
the sale of the product/service to that customer.
Project records are kept up to five (5) years [max] after support has been
discontinued. Project records are any document that LabWare maintains possession
of in support of a customer project, including the following:
Process Flows
Gap Assessments
Project Plans
Design Documents
Functional Description
Acceptance Test Plans
User Documentation
Vendor information is kept at the discretion of Lab Ware.
Personnel records are kept for a minimum of seven (7) years after termination of
employment.
Business Partner information is kept for a minimum of seven (7) years after
termination of the partnership.
Public Health data, HIPAA related data, is not to be accepted by LabWare. All systems
that are related to public health are required to be masked before the material is provided
to Lab Ware.

6 Disposal Policy
All disposed confidential paper documents are shredded prior to removal from the office.

7 Definitions
Business Partners: Companies that provide product or services to LabWare in direct
support of our products or product development. In addition, companies Lab Ware
provides product or services with the intent of re-selling said product or services.
HIPAA: Health Insurance Portability and Accountability Act.
Lifetime Retention: All documents designated as having Lifetime Retention are to be
maintained for the lifetime of Lab Ware Holding. The retention may be in printed or
electronic form.
Personnel Records: Those documents that document compliance with quality
procedures.

Document Name: SOP H20 Record Retention Policy vi .0.1 Effective Date: 15 May 2017
Last Modified: 1 May 2017