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SHEET VALIDATION
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1. INTRODUCTION

Establish a framework of activities and approaches necessary to validate the spreadsheet "Income"
of [Link]" used in the FDA LAB E.U. laboratory. The validation will be carried out in accordance with
the GAMP 5 guidelines to ensure that the spreadsheet is fit for its purpose,
meets user requirements and applicable regulations, and operates reliably and
This validation process will ensure the integrity, accuracy, security, and traceability of
the data managed by the spreadsheet, as well as its compliance with standards
relevant regulations.

2. SCOPE

This validation plan applies to the spreadsheet 'Sample [Link]' and covers all its
features, including data entry, calculations, report generation, and macros
incorporated.

3. FREQUENCY

It is established that, in the absence of significant changes that may affect the validation, it
A validation review will be conducted every three (3) years to confirm its validity and compliance.
continue with the requirements and regulations. This periodic review will ensure that the spreadsheet
it remains appropriate for its purpose and meets the established quality standards

4. RESPONSIBILITIES

Department of Systems

Planning and Execution of Validation: Responsible for planning, coordination and

execution of all validation activities, including the development of plans for
validation, the execution of tests and the documentation of results.
Security and Access Control: Ensure and manage access controls and measures of
security to protect the integrity of the data.

Laboratory Coordinator

Test Supervision: Oversee the execution of validation tests,

ensuring that they are carried out in accordance with established procedures.
Data Management: Ensure that the data entered in the spreadsheet is accurate
and that the integrity of the data is maintained during daily use.
User Training: Coordinate and provide training to end users
about the proper use of the spreadsheet.

Quality Director

Quality Control: Ensure that all validation activities are carried out
in accordance with quality standards and applicable regulations.
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Documentation: Ensure that all documentation related to the validation is

complete, updated and properly archived.

Technical Director

General Supervision: Provide general supervision of the validation process.

ensuring that all technical aspects are considered and addressed
adequately.
Technical Review: Review the technical aspects of the spreadsheet, including the
accuracy of data entry and the functionality of macros.
Final Approval: Give final approval for the use of the spreadsheet after
the validation.

Users

Proper Use: Use the spreadsheet according to the operating procedures

standard and the provided instructions.
Feedback: Provide feedback on the performance of the sheet
calculate and report any problem or error found.
Participation in Tests: Participate in user acceptance tests and others
validation activities as needed.
Data Security: Ensure the integrity and security of the entered data,
following the access and usage policies.

5. USER REQUIREMENTS

The user requirements (URS) for the spreadsheet include, but are not limited to:

Precision and accuracy in sample entry.

Data input validations to ensure data integrity.
Report generation functionality.
Security and access control.
Registration and traceability of changes in the data.
Usability and ease of use for end users.

6. TEST PLAN

The test plan will include the following types of tests:

Design Testing (DQ)

Check that the spreadsheet has been designed according to the requirements of
user and functional specifications.
Review the interface design, the calculation logic, the functionalities of
data import/export and the security measures implemented.

Installation Qualification (IQ) Tests

Check that the spreadsheet has been installed correctly in the work environment.
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Document the installation steps and any problems encountered during the
installation.

Operational Qualification (OQ) Tests

Validate all the functionalities of the spreadsheet.

Data Entry: Verify that the data entries comply with the formats and
allowed ranges.
Calculations and Analysis: Verify the accuracy and precision of the calculations.
Report Generation: Verify that the generated reports contain the information
correct and are in the standard defined format.
Macros: Validate that the macros work correctly and safely.

Performance Tests (PQ)

Ensure that the spreadsheet meets user requirements under conditions

operational.
Performance: Verify that the spreadsheet works efficiently with large
data volumes.
Compatibility: Check that the spreadsheet is compatible with the versions of
Excel used in the laboratory.

7. EXECUTION OF TESTS

Document the test cases, including:

Test case description.

Steps to execute the test.
Expected results.
Results obtained.
Observations and comments
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7.1. DQ Test

Test Code RQU Code Action

Check that the processor has at least 2 cores and a
DQ-001 RQU-001
minimum speed of 1.6 GHz.
DQ-002 RQU-002 Check that the system has at least 4 GB of RAM.

DQ-003 RQU-003 Check that the operating system is compatible with Office 365.

DQ-004 RQU-004 Verify that the system is compatible with Office 365.

7.2. IQ Test

Test Code RQU Code Action

IQ-001 RQU-001 Verify that the processor has at least 2 cores and a
minimum speed of 1.6 GHz.
IQ-002 RQU-002 Check that the system has at least 4 GB of RAM.
IQ-003 RQU-003 Verify that the operating system is compatible with Office 365.

IQ-004 RQU-004 Verify that the system is compatible with Office 365.

7.3. OQ Test

Test Code RQU Code Action

OQ-001 RQU-005 Verify that the field allows entering a username.

Verify that the field allows entering a password and that

OQ-002 RQU-006
this is hidden with characters '*'

OQ-003 RQU-007 Verify that the Enter button verifies the user's credentials.

Verify that the Enter button allows access to the sheets of the
OQ-004 RQU-008
calculus book.
Verify that the form displays an error message when
OQ-005 RQU-009
Incorrect credentials entered.
Verify that the form displays an error message when
OQ-006 RQU-010
enter an incorrect username.
Verify that the form shows an error message when
OQ-007 RQU-011
enter an incorrect password.
Verify that the Change Password button allows access to the
OQ-008 RQU-012
password change form.
Verify that the system remembers the username if it
OQ-009 RQU-013
activate the Remember me option.
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OQ-010 RQU-014 Verify that the field allows entering a new password.

Verify that the field allows entering the confirmation of the

OQ-011 RQU-015
new password.
Check that the Accept button verifies that the passwords
OQ-012 RQU-016
match and are not empty.

OQ-013 RQU-017 Check that the form verifies if the passwords match.

Verify that the Accept button updates the password in the table.
OQ-014 RQU-018
of users.
Verify that the form displays an error message if the
OQ-015 RQU-019
Passwords do not match.
Verify that the Cancel button allows returning to the form of
OQ-016 RQU-020
login.
Verify that the buttons allow access to the functionalities
OQ-017 RQU-021
of the system.
Verify that the button allows access to the delivery form
OQ-018 RQU-022
of certificates.
Verify that the button allows access to the form of
OQ-019 RQU-023
sample modification.
Verify that the button allows access to the login form
OQ-020 RQU-024
of new samples.
Verify that the user can access the options of
OQ-021 RQU-025
system backup.
Verify that only authenticated users can access the
OQ-022 RQU-026
features.
Verify that the system logs each access with the name of
OQ-023 RQU-027
user and position.
Verify that the form allows data entry in the
OQ-024 RQU-028
corresponding fields.
Verify that the form allows selecting the Type of
OQ-025 RQU-029
Sample.
Verify that the form displays the sample type accordingly.
OQ-026 RQU-030
to the selection.
Check that the form enables or disables the boxes according to
OQ-027 RQU-031
the sample type.
Verify that the FDA number is unique, consecutive and follows the
OQ-028 RQU-032
correct format.

OQ-029 RQU-033 Verify that the date follows the correct format (DD/MM/YYYY).

Verify that the form allows selecting the type of sample.

OQ-030 RQU-034
and the corresponding area.
Verify that the button allows saving the entered data and
OQ-031 RQU-035
update the history.
Verify that the button allows to clear all fields of the
OQ-032 RQU-036
form.

OQ-033 RQU-037 Verify that the button allows returning to the main menu.
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Verify that the form allows entering the FDA number of the
OQ-034 RQU-038
show to modify.
Verify that the button loads the corresponding data if the
OQ-035 RQU-039
sample exists in the database.
Verify that the form displays the Modify Form
OQ-036 RQU-040
Check if the FDA number is valid.
Verify that the sheet allows the input of sample data in
OQ-037 RQU-041
the corresponding fields.
Check that the sheet includes specific columns for each type.
OQ-038 RQU-042
of analysis.
Verify that the cells with critical data are protected against
OQ-039 RQU-043
unauthorized modifications.
Verify that the sheet allows for the automatic insertion of new ones.
OQ-040 RQU-044
files for each sample record.
Verify that the sheet automatically calculates the lead time based on
OQ-041 RQU-045
in the entered data.

7.4. PQ Tests

Test Code RQU code Action

PQ-001 RQU-005 Verify that the field allows entering a username
during the actual operation.
PQ-002 RQU-006 Verify that the field allows entering a password and that
this is hidden with characters '*' during the actual operation.
PQ-003 RQU-007 Verify that the Enter button verifies the user's credentials
during the actual operation.
PQ-004 RQU-008 Verify that the Enter button allows access to the sheets of the
calculation book during the actual operation.
PQ-005 RQU-009 Verify that the form displays an error message when
incorrect credentials entered during the actual operation.
PQ-006 RQU-010 Verify that the form displays an error message when
enter an incorrect username during the operation
real.
PQ-007 RQU-011 Verify that the form displays an error message when
enter an incorrect password during the actual operation.
PQ-008 RQU-012 Verify that the Change Password button allows access to the
password change form during the actual operation.
PQ-009 RQU-013 Verify that the system remembers the username if it
activate the Remember me option during the actual operation.
PQ-010 RQU-014 Verify that the field allows entering a new password
during the actual operation.
PQ-011 RQU-015 Check that the field allows entering the confirmation of the
new password during the actual operation.
PQ-012 RQU-016 Verify that the Accept button verifies that the passwords
they match and are not empty during the actual operation.
PQ-013 RQU-017 Check that the form verifies if the passwords match.
during the actual operation.
PQ-014 RQU-018 Verify that the Accept button updates the password in the table
of users during the actual operation.
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PQ-015 RQU-019 Verify that the form displays an error message if the
passwords do not match during the actual operation.
PQ-016 RQU-020 Check that the Cancel button allows returning to the form of
login during the actual operation.
PQ-017 RQU-021 Verify that the buttons allow access to the functionalities
of the system during the actual operation.
PQ-018 RQU-022 Verify that the button allows access to the delivery form.
of certificates during the actual operation.
PQ-019 RQU-023 Verify that the button allows access to the form of
modification of samples during actual operation.
PQ-020 RQU-024 Verify that the button allows access to the login form
of new samples during the actual operation.
PQ-021 RQU-025 Verify that the user can access the options of
System backup during the actual operation.
PQ-022 RQU-026 Verify that only authenticated users can access the
functions during the actual operation.
PQ-023 RQU-027 Verify that the system registers each access with the name of
user and position during the actual operation.
PQ-024 RQU-028 Verify that the form allows data entry in the
corresponding fields during the actual operation.
PQ-025 RQU-029 Verify that the form allows selecting the Type of
Show during actual operation.
PQ-026 RQU-030 Verify that the form shows the sample type of
agreement to the selection during the actual operation.
PQ-027 RQU-031 Verify that the form enables or disables the boxes according to
the sample time during the actual operation.
PQ-028 RQU-032 Verify that the FDA number is unique, consecutive, and follows the
correct format during the actual operation.
PQ-029 RQU-033 Verify that the date follows the correct format (DD/MM/YYYY)
during the actual operation.
PQ-030 RQU-034 Verify that the form allows selecting the type of sample
and the corresponding area during the actual operation.
PQ-031 RQU-035 Verify that the button allows saving the entered data and
update the history during the actual operation.
PQ-032 RQU-036 Check that the button allows to clear all fields of the
form during the actual operation.
PQ-033 RQU-037 Check that the button allows returning to the main menu during
the real operation.
PQ-034 RQU-038 Verify that the form allows entering the FDA number of the
show to modify during the real operation.
PQ-035 RQU-039 Verify that the button loads the corresponding data if the
Sample exists in the database during the actual operation.
PQ-036 RQU-040 Check that the form displays the Edit Form
Register if the FDA number is valid during the real operation.
PQ-037 RQU-041 Verify that the sheet allows the input of sample data in
the corresponding fields during the actual operation.
PQ-038 RQU-042 Verify that the sheet includes specific columns for each type
analysis during the actual operation.
PQ-039 RQU-043 Verify that the cells with critical data are protected against
unauthorized modifications during actual operation.
PQ-040 RQU-044 Verify that the sheet allows the automatic insertion of new ones
Files for each sample record during the actual operation.
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PQ-041 RQU-045 Verify that the sheet automatically calculates the lead time
based on the data entered during the actual operation.
PQ-042 RQU-046 Verify that the sheet "CHANGE_HISTORY" records
automatically each modification made during the
real operation.

8. DOCUMENTATION AND RECORDING OF RESULTS

Record all test results, including any deviations and actions

corrective actions taken. Maintain complete and detailed documentation that supports the
validation process.

The deliverable documentation regarding the spreadsheet MATRIX INCOME OF

SAMPLES FOR ANALYSIS IN FDA LAB U.S. are available:

Validation Plan
User Requirements
Functional Specifications
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ) Rating
Performance Rating (PQ)
Report and Tracking

9. CONCLUSION AND APPROVAL

Prepare a final validation report that summarizes the test results and confirms
that the spreadsheet meets user requirements and applicable regulations.
Obtain the approval of the validation report from the stakeholders.