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N°: WI-SSA-ICT-005-E
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SOFTWARE PRODUCTS
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WORK INSTRUCTION

VALIDATION AND MANAGEMENT OF

SOFTWARE PRODUCTS

WI-SSA-ICT-005-E

F. VIVIER J. MEDINA LUNA C. SEGUIN P. JEZEGOU

03/02/09 1 First issue
ICT QUAL ORGA ICT

Date Revision Description of Revision Prepared by Checked by Approved by

Only the electronic version is updated, before any use the current version of this document shall be verified on the INTRANET network

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REVISION RECORDING

Date Revision Description of Revision Prepared by Checked by Approved by

F. VIVIER J. MEDINA LUNA C. SEGUIN P. JEZEGOU

03/02/09 1 First issue
ICT QUAL ORGA ICT

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INDEX

1. SCOPE AND PURPOSE ............................................................................................................................4

2. REFERENCE DOCUMENTS......................................................................................................................4

3. DEFINITIONS .............................................................................................................................................4

4. ACTIVITIES DESCRIPTION.......................................................................................................................5
4.1 AIMS AND OBJECTIVES .........................................................................................................................5
4.2 CLASSIFICATION OF SOFTWARE............................................................................................................5
4.3 DESCRIPTION OF WORK PROCESS ........................................................................................................6
4.4 SOFTWARE VALIDATION .......................................................................................................................6
4.4.1 Software Level 1 ..................................................................................................................7
4.4.2 Software Level 2 ..................................................................................................................8
4.4.3 Software Level 3 ..................................................................................................................8
4.5 CONFIGURATION MANAGEMENT............................................................................................................8
4.6 RESPONSIBILITIES, DUTIES AND ORGANIZATION .....................................................................................9
4.6.1 User department ..................................................................................................................9
4.6.2 ICT department ..................................................................................................................10
4.7 VALIDATION DOCUMENTS ...................................................................................................................11
4.8 FILING AND ARCHIVING OF RECORDS ..................................................................................................11

5. FLOWCHART ...........................................................................................................................................13

ATTACHMENT A – CHECK LIST OF INFORMATION ON A SOFTWARE ..........................................1/2

ATTACHMENT B - SOFTWARE VALIDATION REPORT .....................................................................1/1

ATTACHMENT C - ENGINEERING DATA SHEET FOR THE QUALIFICATION OF SOFTWARE

USER (EXAMPLE) ..................................................................................................1/1

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1. SCOPE AND PURPOSE

This procedure describes the work process, operating practices, responsibilities and documents
produced for the validation and management of the configuration of software products used within
Saipem s.a. It applies to any software for which a RAU is assigned.
The procedure applies both to the software products owned by Saipem s.a. (developed especially for
Saipem s.a.) and to those acquired on the market.
The instructions given should also be considered as guidelines for the entire Saipem s.a. sector, with
exception in the local organizational structure.

2. REFERENCE DOCUMENTS

• "Quality Management Systems – Requirements" (ISO 9001:2008)

3. DEFINITIONS

Configuration Management Activities aimed at ensuring the mechanisms needed for identifying,
checking and following a Software by keeping a record of its history so
as to allow the correct version to be used.

IT Information Technology

RAU “Responsable d’Application Utilisateur”

For each software, the RAU is the focal point for the Software users
(inside or outside his own Department). He is in charge of the support
of the software use.
He is the focal point of ICT for the Software follow-up (new version
acceptance, validation of the Software installation, validation of the
Software itself, ...).

RDSI “Responsable Département Systèmes d’information”

He is the Sofware referent for all the IT purposes inside his own
Department. He is mainly in charge of the validation of access rights,
management of software requests, in coordination with the RAU.

Software documentation Documents (in paper or electronic file support) required for using and
implementing the Software (Installation manual…) and which form an
integral part of the software.

Software validation Process analysis and appraisal of Software aimed at ensuring its
conformity to specified or expected requirements.

For a better understanding and readiness of this document, the following abbreviations will be used:

ICT Information & Communication Technologies: Department in charge of

computer systems support within Saipem s.a. organization

Software products Software

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User Department Saipem s.a. Department which uses the Software for its activities and
which validates it for a specific use in coordination with its assigned
RAU for the software.

4. ACTIVITIES DESCRIPTION

4.1 AIMS AND OBJECTIVES

The aims and objectives of the software validation and management process are as follows:
• ensuring that reliable Software are used,
• unequivocally identifying the available official versions of the Software,
• ensuring that Software documents are updated and coherent (user manuals, installation
manuals…),
• ensuring the managing of the configuration and the controlled distribution of Software,
• ensuring that Software are used in compliance with the intended application, prior to initial
use.

4.2 CLASSIFICATION OF SOFTWARE

Software used within Saipem s.a. are classified in accordance with these following three levels in
relation to their criticality:
• Level 1
This level includes Software whose output is critical in terms of design, engineering, safety
and environment or that are, in any case, critical to Saipem s.a.. In particular, this level
includes all Software which use calculations, rules, and simulations, in order to provide
results to be used for design and construction activities.
(Examples: CAESAR, OLGA, ROBOBAT…)

• Level 2
This group of Software plays is used in the execution of planning and control activities. It has
a limited impact on design results and on the technical solutions used at engineering level
with regard to safety and environmental aspects. Generally this software utilizes data
provided by the Engineer or outputs from other programs and produces drawing, sketches,
reports, lists….
This level includes management programs.
(Examples: PRIMAVERA, material management, CAD….)

• Level 3
This group of Software is made up of standard work tools of large-scale international
diffusion, such as word-processing, spreadsheet, plotting programs or similar, general
estimating programs, etc.
These Software have no effects on the quality of design.
It is not mandatory to assign a RAU for this level of Software.

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Nota: In-house Software must be classified following the same rules by the user Department
with the support of ICT.

4.3 DESCRIPTION OF WORK PROCESS

The work process described in this procedure is made of the following phases:
• Software validation
• Configuration management
All major release of an existing Software, level 1 or level 2, must follow the entire work process
described in this document.

4.4 SOFTWARE VALIDATION

The validation of Software is carried out by analyzing and reviewing existing documentation as
per the following matrix.

User
ICT RAU
Department
Verify the correctness, clearness and completeness of the
X
Software documentation

Make sure that, wherever necessary, the results arising from the
use of the Software comply with the development hypotheses and
algorithms of the products themselves and that any documents X
produced (printouts, drawing, etc) respect the necessary
requirements of being clear and complete

Assign a RAU for the Software X

There is a CD/DVD with the data-processing sources of the
X
software and installation information
Verify that a copy of software resources is stored on the network X

Ensure that an installation notice, including hardware requirements

X
if any, is stored on the network

Make sure that Editor and license documentation is clear and

complete (purchase information, editor information’s, nature of X
license, technology license control…)
Update the existing list of Engineering software available in ICT X

Validate (or not) the installation of patches provided by the supplier

X
or Saipem s.a. (in house Software)

The validation of Software differs depending on the Software classification level.

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4.4.1 Software Level 1

User
ICT RAU
Department
VALIDATION PROCESSING

a) Check to ensure that there is a user manual (paper or

electronic file included in the Software itself) which defines
the application limits of the Software and that it is accurate X
as well as complies with the current version of the Software
itself

b) Check to ensure that the appropriate documents on the

logic used for developing the product, are available and that
the theoretical principles, equations, technical-scientific X
articles, design codes, etc. used are included or indicated in
one of the reference documents of the product

c) Appraisal of the reliability of products on the basis of

X
references (practical use, previous projects, etc)

d) Presence of number of tests when either a new product

or a new version of previously validated software needs to
be validated. Tests chosen must be such as to cover the
X
fields in which the product is used for standard activities.
The tests, the checking and appraisal of the results must be
carried out and documented with the necessary experience

e) In case of a Software elaborated by Saipem s.a. (in-

house software), results can be checked by comparing
them with:
- Manually calculated data
- The results of other programs of known reliability X
- Data and results given in literature
- Experimental data
- Practical experience (evaluation based on past
experience, previous projects….)

f) In the case of market-place products, the documentation

regarding the product and the supplier (if not well
established) must be examined before the above detailed
checks a) b) c) d) e) f), as well as the product references X X
and any certificates presented, requesting clarifications.
The amount and extent of the detailed checks to be made
will be established also in consideration of these elements.

OUTPUT DOCUMENTS

- A “Check list of information on the Software” X X

- A “Software Validation Report” is issued on the basis of

reference documents produced and on completion of the
X
above activities; the purpose of the report is to validate the
Software and allow it to be used.

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4.4.2 Software Level 2

User
ICT RAU
Department
VALIDATION PROCESSING

a) Check to ensure that there is a user manual (paper or

electronic file included in the Software itself) which defines
the application limits of the Software and that it is accurate X
as well as complies with the current version of the Software
itself

b) Check to ensure that the appropriate documents on the

logic used for developing the product, are available and that
the theoretical principles, equations, technical-scientific X
articles, design codes, etc. used are included or indicated in
one of the reference documents of the product

c) Check to ensure that main functions and references, if

X
any, have been verified

d) In the case of market-place products, the documentation

regarding the product and the supplier (if not well
established) must be examined before the above detailed
checks a) b) c), as well as the product references and any X X
certificates presented, requesting clarifications. The amount
and extent of the detailed checks to be made will be
established also in consideration of these elements.

OUTPUT DOCUMENTS

- A “Check list of information on the Software” X X

- A “Software Validation Report” is issued on the basis of

reference documents produced and on completion of the
X
above activities; the purpose of the report is to validate the
Software and allow it to be used.

4.4.3 Software Level 3

No validation activities are required for the Software of level 3. Consequently, no
documents are issued.

4.5 CONFIGURATION MANAGEMENT

The process of configuration management of the Software is essentially distinguished by the
controlled distribution of the products themselves and is carried out by identifying and cataloguing
the characteristic elements, the reference documents and the User departments of each product.
This management is supported by appropriate data-processing instruments.
The following takes place for all Software:
• Certification, marking and protection of original copies of the Software (sources modules,
compiled modules and executable modules) and of associated reference documents
• Elimination of all other copies of the program and documents or keeping them on a history file

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• Installation only of copies of Software that have been certified and checked and of associated
reference documents, keeping a suitable record.

4.6 RESPONSIBILITIES, DUTIES AND ORGANIZATION

The main responsibilities are shared between ICT Department and the User Department
according to the following principles:
• The User Department is responsible for validating (reliability of output) and classifying the
Software
• ICT uses and controls outsourcers of an appropriate level, so as to ensure compliance of the
Software specifically developed to meet the user’s requirements
• ICT is responsible for installing and managing the configuration of the Software of Saipem
s.a.
• ICT checks the classification assignment of the Software.
The duties and responsibilities of the various Saipem s.a. Departments for the above activities
are as follows:

4.6.1 User department

For each software, the User Department assigns a RAU who is the unique focal point to
ICT and who is responsible for:
a) Assisting the RDSI during the validation of the Software request
b) Classifying the Software and checking, defining and documenting associated limits
and fields of use in coordination with ICT Department
c) Arranging the tests to be carried out in order to verify the Software, with the
contribution of ICT Department if required, carrying them out, assessing them and
documenting the results where necessary
d) Assessing the information and the certificates received from the suppliers using the
general check-list FORM-SSA-ICT-001-E given in Attachment A for all software level
1 and level 2.
e) Preparing and issuing the FORM-SSA-ICT-002-E “Software Validation Report”, given
in Attachment B, with the contribution of ICT Department if required, with regard to
the architectural configuration of software.
f) Proposing the FORM-SSA-ICT-002-E “Software Validation Report”, to the validation
of the User Department manager.
g) Delivering the original and certified copy of the respective reference documentation
(including Software Validation Report) to the ICT Department on completion of the
validation process.
h) Requesting the ICT Department to install Software, both for those products acquired
from outside Saipem s.a., and for those belonging to Saipem s.a.
i) Assessing the Software users of the department and keeping the authorized users list
up-to-date. An example of a user assessment form is given in Attachment C.

Nota: Numbering system for the Check-list of information and the validation report for
Software must initiate with Revision 01.

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4.6.2 ICT department

Is responsible for:
a) Asking the supplier for product documentation and available certificates, as well as
for also requesting any additional information deemed necessary by the User
Department
b) When asked to, lending its own contribution to define the check tests of the Software
c) When asked to, lending its own contribution to the preparation of the “Software
Validation Report”, with regard to the architecture configuration of the software,
requesting the involvement of the ICT Department if necessary
d) Making sure that there is appropriate documentation for the controlled installation of
the Software.
e) Managing all the Saipem s.a. Software developed by Outsourcers and/or acquired
outside and, in particular, ensuring that files and registers of Software and associated
documents (user and theory manuals, etc.) are kept and updated.
As a guide, the elements, items and functions that take place and are managed, are
as follows:
− Identification of products using the following data:
− Name
− Title
− Version and release
− date of issue
− code, if any
− classification level
− product status with regard to validation activities
− Updating the Register of Software, user and maintenance manuals, …
− Management of files relating to:
− original copies of the Software, of the user manuals (or indication of
the place in which they are kept) and of the maintenance manuals
− main information of the supplier
− Software Review Reports
− Software Validation Certificates
f) Installing Software for Departments requesting their installation, issuing authorized
and controlled copies of Software and associated documents.
Software from third parties may only be installed after having ascertained that
installation is permitted by the respective license contract. Software Level 1 and 2, if
not validated, may be installed, for example, for personnel test or training needs, only
with the express authorization of the responsible person of the user department, who
will ensure their correct use.
g) Placing the necessary information regarding the existence or new version of the
Saipem s.a. Software at the disposal of the Saipem s.a. Departments.
h) Managing the software configuration
i) Defining, documenting and applying the operation procedures with regard to the
protection of Software (infringement, safety, security…)
j) Maintaining the software validated list updated, specifying for each software the

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corresponding RAU
k) Maintaining the RDSI list updated
l) Ensuring that related licence are available and meet all the users Department needs.

4.7 VALIDATION DOCUMENTS

The validation of a Saipem s.a. Software is documented by the documents described in the
following chapters, for the preparation of which suitable forms in Word are available.
• Check list of information on the software
Refer to FORM-SSA-ICT-001-E given in Attachment A.
This general check list may be useful for identifying the Suppliers' information. It applies only
for Software level 1 and level 2.
The RAU is in charge of filling this document.

• Software Validation Report

Refer to FORM-SSA-ICT-002-E given in Attachment B.
This report describes the status of the Software and contains information needed to:
− unequivocally identify the Software
− define the product classification level
− identify reference documents associated to the Software and of which they form an
integral part
− identify documents describing the check and validation tests
− check the reliability of results on the basis of practical use, previous projects, etc.
This certifies the completion of checks and validation tests on the Software; it allows the
Software to be used by the Departments involved in the respective fields of application.

4.8 FILING AND ARCHIVING OF RECORDS

IT department is responsible for safeguarding and archiving all documents relating to software in
use within Saipem s.a. (paper or electronic file included in the Software itself). It concerns
software validation documents, old versions…
The conservation of original documents of the current version (with signature) is on electronic or
paper support. Out-of-date versions are conserved in the ICT Department and then archived in
electronic support according to the following rules.

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Archive
Type of Responsible Conservation Archiving retention time
document of archiving Medium Medium (from the
Archiving date)
ICT current version : paper electronic
Purchase order 3-5 years
Department and electronic version version
Electronic file :
ICT Current version : network and
source of 3-5 years
Department electronic version CD Rom
software
ICT Current version : network and
Installation notice 3 years
Department electronic version CD Rom
Check list of Current version : paper
ICT network and
information on the and/or electronic 3-5 years
Department CD Rom
Software version
Current version : paper
Software ICT electronic
and/or electronic 3-5 years
validation Report Department version
version
Engineering Data
Current version : paper paper and/or
Sheet for User
and/or electronic electronic 3-5 years
qualification of Department
version version
software user

IT Department makes accessible validated documentation to RDSI, User Department's

Responsible person and process owners.

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5. FLOWCHART

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ATTACHMENT A – CHECK LIST OF INFORMATION ON A SOFTWARE

FORM-SSA-ICT-001-E

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ATTACHMENT B - SOFTWARE VALIDATION REPORT

FORM-SSA-ICT-002-E

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ATTACHMENT C - ENGINEERING DATA SHEET FOR THE QUALIFICATION OF SOFTWARE USER

(EXAMPLE)

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