GLP Support/Maintenance

Trade Agreement: NONE
Tendering Procedures: Generally only one firm has been invited
to bid
Attachment: None
Non-Competitive Procurement Strategy: Government Objectives
Representing Best Interests/Value to Govt
Comprehensive Land Claim Agreement: No
Vendor Name and Address: 
Brendan Hyland
204 11th Street SW
Medicine Hat Alberta
Canada
T1A4S4
Nature of Requirements: 
Title:	Development of Data Analysis Tools, Acquisition Processes
and Validation Routines for Good Laboratory Practice Systems and
Provision of GLP Engineering Support

1. Advance Contract Award Notice

An ACAN is a public notice indicating to the supplier community
that a department or agency intends to award a contract for
goods, services or construction to a pre-identified supplier,
thereby allowing other suppliers to signal their interest in
bidding, by submitting a statement of capabilities. If no
supplier submits a statement of capabilities that meets the
requirements set out in the ACAN, on or before the closing date
stated in the ACAN, the contracting officer may then proceed
with the award to the pre-identified supplier.

2. Definition of Requirement

The Department of National Defence, Defence Research
Establishment Suffield, Ralston, AB has a requirement for
engineering support. 

The Principles of Good Laboratory Practice (GLP) as governed by
the Organization for Economic Co-operation and Development
(OECD) and the United States Food and Drug Administration (FDA)
specify that maintaining the integrity of raw data is a critical
component to compliance with GLP. Both OECD and FDA provide
guidance on the validation, maintenance and use of computerized
systems, laboratory equipment and data analysis tools used in
GLP studies. In the case of FDA GLP studies, this includes the
requirements of 21  Code of Federal Regulations (CFR) Part 11
for electronic data.

Standard Operating Procedures (SOPs) have been put in place at
DRDC Suffield to address procedures around setting design
requirements for, acquiring, setting up and validating GLP
computer systems, and data analysis tools. These SOPs must meet
the evolving requirements of the GLPs for modern laboratory
environments such as auditing e-data and meeting 21 CFR Part 11
requirements in the networked environment. In addition to these
general procedures, detailed procedures and validation routines
for some specific systems must also be established, including a
protected GLP data network, e-data handling and backup, and the
upcoming implementation of the eNovator LIMS system for GLP data
and systems.

In addition to the hardware used in the GLP environment, the
data analysis tools used in GLP studies must be developed,
validated and maintained in a complex software lifecycle
approach. The procedures for this development and validation
lifecycle in the DRDC Suffield GLP environment have been
established during the first GLP study, and now must be applied
to data analysis tools being developed during the implementation
phases for upcoming GLP studies.

The GLP system at DRDC Suffield has been implemented through the
development of a SOP system that describes all facets required
for GLP and ongoing maintenance of the system is required. In
addition, the system will be spread to other parts of the
Section that have significant technical complexities that must
be addressed if these facilities are to be made GLP compliant
(e.g. Surgical Suite, Behavioural Laboratory). Engineering
support is required for these areas.

Due to the nature of this work it is expected that there will be
follow-on contracts.

3. Criteria for assessment of the Statement of Capabilities

Any interested supplier must demonstrate by way of a statement
of capabilities that it meets the following requirements:

a) Education:  Masters of Science or Engineering
b) Experience:  Implementation of Organization for Economic
Co-operation and Development (OECD) & Food and Drug
Administration Good Laboratory Practice (FDA GLP) compliant
programs; Writing of SOPs, methodology and user manuals; Project
management; Computer programming; GLP validation of computerised
systems and data systems.
c) The contractor must at all times during the performance of
the Contract, hold a valid Designated Organization
Screening(DOS), issued by the Canadian Industrial Security
Directorate (CISD), Public Works and Government Services Canada
(PWGSC).

4. Applicability of Trade Agreements

This procurement is subject to the following trade agreements:
Agreement on Internal Trade (AIT), 
World Trade Organization - Agreement on Government Procurement,
(WTO-AGP) North American Free Trade Agreement (NAFTA)

5.  Justification for Pre-Identified Supplier

The proposed contract is a direct continuation of the previously
competitively tendered  requirement.  (Contract Number:
W7702-09P382/001/EDM).  There was no approved strategy so DRDC
Suffield implemented Good Laboratory Practice (GLP) from 2005 to
2007 and a contractor is required for the ongoing maintenance of
the GLP System, whether a study is being run or between studies.
The personnel that maintain this capability must be fully
conversant in the Principles of GLP.  The complexity of the GLP
System and the processes in place to: maintain and validate GLP
equipment systems; put in place and maintain GLP data analysis
tools and procedures; sustain the GLP System using an electronic
notebook system; and keep the GLP Standard Operating Procedure
(SOP) system compliant would require, at minimum, twelve months
of full time workup for another professional coming in at ground
zero.  This would be required to understand the GLP System put
in place at DRDC Suffield and understand the complexities of the
data analysis validations required, furthermore this would push
GLP Studies back by the period spent learning by a new
contractor.

6.  Government Contracts Regulations Exception

The following exception to the Government Contracts Regulations
is invoked for this procurement under subsection 6(d) - "only
one person is capable of performing the work".

7  Exclusions and/or Limited Tendering Reasons

The following exclusions and/or limited tendering reasons are
invoked under the section of the trade agreement specified:

Agreement on Internal Trade (AIT) - Limited Tendering under
Article 506, #12 b
North Ameriican Free Trade Agreement (NAFTA) - Limited Tendering
- Article 1016: b.
WTO-AGP not applicable, as per Services in Appendix I, Canada -
Annex 4.

8.  Ownership of Intellectual Property

Defence Research and Development Canada (DRDC) has determined
that any intellectual property arising from the performance of
the Work under the Contract will vest in Canada. DRDC is
exempted from the Treasury Board "Policy on Title to
Intellectual Property Arising Under Crown Procurement Contracts"
approved 1 June 2000.

9.  The Period of the Proposed Contract

The proposed contract is for a period of approximately 2 years,
from May 1, 2012 to March 31, 2014, with an option to extend for
an additional two, one year periods ending on March 31, 2016.

10.  The Estimated Cost of the Proposed Contract

The estimated value of the contract, including options is
$470,000.00, GST extra for the 4 year period.


11.  Name and Address of the Pre-Identified Supplier:

Brendan Hyland Quality Systems
221 - 5th Street SE
Medicine Hat, AB    T1A 0M5

12.  Suppliers' Right to Submit a Statement of Capabilities

Suppliers who consider themselves fully qualified and available
to provide the goods, services or construction services
described in the ACAN, may submit a statement of capabilities in
writing to the contact person identified in this notice on or
before the closing date of this notice. The statement of
capabilities must clearly demonstrate how the supplier meets the
advertised
requirement.

13.  The Closing Date and Time for Accepting Statements of
Capabilities

April 5, 2:00 pm (MDST)

14.  Inquiries and Submission of Statement of Capabilities

Inquiries and statements of capabilities are to be directed to:

Elaine Barton, Supply Specialist
Public Works and Government Services Canada
Telus Plaza North
5th Floor 10025 Jasper Avenue
Edmonton, AB   T1J 1S5

Telephone:780-497-3519
Facsimile: 780-497-3510
E-mail: elaine.barton@pwgsc-tpsgc.gc.ca

Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate
with one firm only as identified above. Should you have any
questions concerning this requirement, contact the contracting
officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and
agencies to post a notice, for no less than fifteen (15)
calendar days, indicating to the supplier community that it
intends to award a good, service or construction contract to a
pre-identified contractor. If no other supplier submits, on or
before the closing date, a Statement of Capabilities that meets
the requirements set out in the ACAN, the contracting authority
may then proceed with the award.  However, should a Statement of
Capabilities be found to meet the requirements set out in the
ACAN, then the contracting authority will proceed to a full
tendering process.

Suppliers who consider themselves fully qualified and available
to provide the services/goods described herein, may submit a
statement of capabilities in writing to the contact person
identified in this Notice on or before the closing date of this
Notice. The statement of capabilities must clearly demonstrate
how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the
closing date of the ACAN must appear on the outside of the
envelope in block letters or, in the case of a facsimile
transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any
procurement.

Documents may be submitted in either official language of Canada.