C-111

Redzone General Use

Section C — Record Management Revision 1 23 pages

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1.0 Purpose

The purpose of this procedure is to provide instructions for general operations within Redzone.

2.0 Scope

This procedure applies to the general use of Redzone. SOPs specific to particular functions or

tasks provide details for the use of Redzone as applicable.

3.0 Responsibility

al All employees that use Redzone (i.e. have a Redzone login profile) must understand the

basic Redzone principles outlined in this procedure.

Be It is the responsibility of Document Control to periodically review and provide updates

to this procedure.

4.0 Definitions

4.1 RZ — Redzone;, Mark Sutcliffe founded Redzone Production Systems in 2013. The

company website is https://rzsoftware.com/ and provides additional information about

the product.

4.2 RZ Admin — When written in bold and italic font, this is the Redzone backend

application used to configure the system.

4.3 Redzone — When written in bold and italic font, this is the Redzone frontend user

application.

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44 Backend Application — The backend application provides tools to set user permissions,
define locations to use RZ, define products and associated characteristics, define shifts,

define datasheets, and define triggers.

4.5 Frontend Application — The frontend application provides the interface for using the

RZ Software in the production environment. It is the end user interface.

4.6 Datasheet — Unless explicitly stated otherwise, a datasheet is an RZ component of the
RZ Compliance Module that is configured in RZ Admin and used in Redzone to collect

data.

4,7 Handwritten Signature — Handwritten signature means the scripted name or legal

mark of an individual handwritten by that individual and executed or adopted with the

present intention to authenticate writing in a permanent form. The act of signing with a
writing or marking instrument such as a pen or stylus is preserved. The scripted name or

legal mark, while conventionally applied to paper, may also be applied to other devices
that capture the name or mark.

4.8 Digital Signature — Digital signature means an electronic signature based upon
cryptographic methods of originator authentication that is computed by using a set of

tules and a set of parameters such that the identity of the signer and the integrity of the

data can be verified.

4.9 Electronic Record — Electronic record means any combination of text, graphics, data,

audio, pictorial, or other information representation in digital form that is created,
modified, maintained, archived, retrieved, or distributed by a computer system.

4.10 Electronic Signature — Electronic signature means a computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by an individual to be the

legally binding equivalent of the individual’s handwritten signature.

4.11 cGMP — Current Good Manufacturing Practices

4.12 Sign Off — Approval of quality checks conducted during a completed run

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4.13 Action Number (#) — a unique number assigned to each data sheet. Actions number are
available at the top of the data sheet on the action screen for data sheets that are not

completed and at the top of the data sheet for data sheets that are completed. The action
number is also visible in the comments section next to each linked data sheet.

4.14 Statistical Process Control (SPC) — a set of statistical rules to evaluate data from a

process as data is collected and indicate when adjustments are needed to maintain
control of that process. SPC configuration of data sheets identifies specific numerical

product characteristics (e.g. tablet or capsule weight, tablet thickness, etc.) to apply SPC
rules to.

5.0 References

5.1 A-106, SOP, Documentation Guidelines for cGMP Records

5.2 QS-116-F1, Form, Electronic Signature Acknowledgement and Consent

6.0 Overview

6.1 Ion Labs uses RZ for both non-GMP business functions as well as cGMP-regulated

functions. RZ utilizes “data sheets” to collect cGMP data and electronic signatures.

Ion Labs uses RZ data sheets to replace many conventional paper-based systems for
logbooks, forms, and batch data. RZ is capable of automating the initiation of data

sheets and is able to send out alerts based on various events, periods, or data sheet
status. This automation helps ensure compliance with SOP and regulatory

requirements.

6.2 This procedure provides general instructions for using RZ and RZ tools. Other

procedures specific to a particular task or function provide detailed direction for using

RZ in those activities

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7.0 RZ Knowledge Base

7.1 The Knowledge Base available in the Redzone application and the RZ Admin

application both accessed through the “More” tab provides detailed information about

navigating within the application and provides “how to” details to perform many of the
functions described by this procedure, which is not necessary to repeat here. Consult

the Knowledge Base as needed.

8.0 Main Screen

8.1 The following screen shot shows the main screen of the Redzone application with

“Chats” selected.

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8.2 The main screen provides access to the key focus areas, seen across the bottom of the
screen with an overview of the functionality below.
8.2.1 Chats

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8.2.1.1 This area of RZ organizes communication between groups, as well as
automated alerts and comments. Personnel initiate chats as needed

much like texting on a phone. All forums create a chat group

automatically. Admins may create new chat groups in the RZ Admin
application.

8.2.1.2 Navigate to Chats as follows:

e Main Screen — Chats

8.2.2 Forums

8.2.2.1 The Forum is the basis for action cycles in Redzone. Use Forums to

organize and monitor meetings, huddles, or kaizen events. Forum
Types include Huddle, Daily, Weekly, or Custom. Open a forum by

selecting the forum and then selecting “Open Forum” in the upper right

corner of the screen. Begin the forum meeting by clicking the play
button in the top right of the screen. Admins may create new forums in

the RZ Admin application.

S.2dud Navigate to Forums as follows:

® Main Screen — Forums

8.2.3 Activities

8.2.3.1 Activities are a key concept in driving accountability and follow up in

Redzone. There are many different places that activities can be created.
This ensures that users can quickly and easily create them from

anywhere in the application, saving time and ensuring the information
is captured and enters the action cycle.

S232 There are four main components in Activities:

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® Actions

® Issues

° Ideas

e Work Requests

8.2.3.3 All activities can be found in one central location in the Redzone app,

under the Activities menu tab along the bottom of the screen. This
activities dashboard will default to showing only unassigned activities

and activities assigned to the logged in user. View activities in either a
List view or a Board view.

8.2.3.4 Navigate to Activities as follows:

C) Main Screen — Activities

8.2.4 Operations

8.2.4.1 The Operations Dashboard is key to getting information about
production activity in each area and location. The dashboard updates

automatically on a periodic basis. In the upper right corner of the
dashboard are options to manually update the dashboard, viewa list of

huddles, and filter the contents displayed.

8.2.4.2 Selecting an area displays locations in that area. Selecting a location

from there or directly from the main dashboard opens the dashboard

for that specific area. More information is available on this dashboard
by swiping left and right. From this location dashboard, there are

additional opportunities to navigate to detailed information about that
location by selecting from the options on the left which include the

following:

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e Data Center

Settings

Problems

Quality

e Log

8.2.4.3 Navigate to Operations as follows:

e¢ Main Screen > Operations

8.2.5 Quality

8.2.5.1 The quality dashboard provides an overview of all location similar to

the operations dashboard; however, the information summarized on

this dashboard focuses on data sheets rather than productivity metrics.
Each location displays colored tiles for each completed data sheet

indicating the status of the data sheet (Pass, Warn, Fail, Missed,
Cancelled, or Voided). Each location displays the number of pending

data sheets next to an ellipsis ®@@@ which if selected provides options

for more detailed views as follows:

e Pending Data Sheets (a shortcut to the pending data sheets for

that specific location)

e Run Quality Dashboard

e Operations Page (a shortcut to the Operations page for that

location)

Note: Viewing pending data sheets from the main screen Quality dashboard

will display all pending data sheets, while viewing the “Backlog Data

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Sheets” from the Operations Quality Screen does not display data
sheets that are not configured as “operation checks” and are instead

intended for Quality to complete

8.2.5.2 Navigate to Quality as follows:

e Main Screen — Quality

8.2.6 Kaizan

8.2.6.1 The Kaizen dashboard allows the creation, tracking, and reporting of

Kaizen events. This feature is currently not in use.

8.2.6.2 Navigate to Kaizan as follows:

° Main Screen — Kaizan

8.2.7. More

8.2.7.1 The “More” option on the main screen provides a number of
miscellaneous functions, many of which are available through other

dashboards and screens, but may present these items in a different

format. The list below provides available options with the most
frequently used in bold font.

e Profile — select preferred language, update use passwords and
signature pins, and adjust preference settings

e Knowledge Base — provides detailed information about

navigating within the application and provides “how to” details
to perform many RZ functions

e Create — allows the creation of actions, issues, and ideas; you
may also start a chat, quality check, production check, or audit

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Forums — lists available forums

Locations — lists locations

Fishbones — lists completed fishbone diagrams (this feature is

currently not in use)

My Dashboard — displays the same dashboard by selecting

“Operations” at the bottom of the main screen

Sign Off Dashboard — displays a dashboard designed to sign off

runs if the use has appropriate permissions to do so

1 Panel View — uses filters to look at various information (e.g.

OEE Trend, Availability Trend, Quality Trend, etc.) across

specific areas over a specified period of time

2 Panel View — summarizes OEE and Problems for specific sites,

areas, or locations over a specified period

Historical Report Search — uses filters to view Shift Reports, Run

Report, or Quality Reports; allows the narrowing of results to

specific locations, products, periods, Run ID, or customer
reference parameters

Data Sheet History — uses filters to view data sheets; allows the
narrowing of results to specific data sheet type or template name,

as well as data sheets executed for specific locations, products,

results, product groups, manufacturing types, assets, asset types,
periods, etc.; allows for the search of specific results entered into

the data sheet

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SPC Report Search — uses filters to view data sheets; allows for
the narrowing of results to specific locations, products, and

product characteristics; also include a period for included data

8.2.7.2 Navigate to the “More” options as follows:

Main Screen — More

9.0 Operations Screen

9.1 Navigate to the Operations screen as follows:

9.1.1 Main Screen — Operations

9.2 Selection of the Operations tab on the Main screen displays a list of available sites,

areas, and locations. The image below shows the top portion of this list.

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9.3 Scrolling down on this screen allows view of individual locations. This screen provides

a summary of the subject site, area, or location. Selection of a specific Site or Area

provides a similar screen with locations associated for that selection. Selection of a
specific location provides a more detailed Location Screen.

9.4 Operations Location Screen

9.4.1 Main Screen — Operations = select a specific location

9.4.2 Main Screen > Operations — select a specific area — select a specific location

9.4.3 Main Screen — Operations — select a specific site > select a specific area >

select a specific location

9.4.4 Selection of a specific location from the Operations screen provides options to

view details about that location.

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9.4.5 Swipe left or right to see other summary views for this location. Select options
on the left of the screen to see other detail views. The image above displays a

red box around the “Quality” option, indicating that there are data sheets ready
for execution at this location.

9.5. Operations Quality Screen

9.5.1 Navigate to the Operations Quality Screen as follows:

9.5.1.1 Main Screen + Operations — select a specific location > Quality

9.5.2 The Operations Quality Screen is available by selecting the “Quality” option on
the left side of the Operations Location Screen. The image below shows the

default view after selecting this option.

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9.5.3. At the bottom of this screen are options for viewing data sheets and information

about data sheets.

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9.6 Backlog Screen

9.6.1 Navigate to the Backlog screen as follows:

9.6.1.1 Main Screen —> Operations — select a specific location > Quality >
Backlog

9.6.2 The default view is “Backlog”. At the top of this Backlog view are options to
search for and filter data sheets. This screen summarizes datasheets issued to the

location.

Note: Some datasheets associated with what is active in this location may not appear
here if they were not issued to the location and are intended for Quality to

complete. To see all associated datasheets, use the Quality Dashboard.

a Control State

9.7.1 Navigate to the Control State screen as follows:

9.7.1.1 Main Screen — Operations — select a specific location > Quality —

Control State

9.7.2 The Control State option in the Operations Quality screen allows the view of

SPC characteristics.

9.8 Quality Run Summary

9.8.1 Navigate to the Quality Run Summary as follows:

9.8.1.1 Main Screen — Operations — select a specific location > Quality >
Report

9.8.2 See discussion of “Understanding the Quality Run Summary Screen/Report” in
this procedure.

9.9 Operations Quality Dashboard

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9.9.1 Navigate to the operations Quality Dashboard as follows:

9.9.1.1 Main Screen Operations — select a specific location —> Quality >

Dashboard

9:43 AM Thu Mar3
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9.9.2 The Operations Quality Dashboard is similar to the Quality Dashboard accessed

from the main menu, with the exception of the fact that it only displays

information for the currently selected specific location. See the “Quality
Dashboard” discussion in this procedure for more details.

10.0 Quality Dashboard

10.1 Navigate to the Quality Dashboard as follows:

10.1.1 Main Screen — Quality

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9:36 AM Thu Mar 3
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10.2 The Quality Dashboard provides a summary of completed data sheets, indicating the

status of the data sheet (Pass, Warn, Fail, Missed, Cancelled, or Voided). Each location
displays the number of pending data sheets next to an ellipsis @@@ which, if selected,

provides options for more detailed views as follows:

10.2.1 Pending Data Sheets (a shortcut to the pending data sheets for that specific

location)

10.2.2 Run Quality Dashboard

10.2.3 Operations Page (a shortcut to the operations page for that location)

10.3 Each location line also displays a run sign off icon 0. that changes color based on sign

off status (see color picture below with color description if printed in black and white).

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Not Signed Off

Partial Sign Off

Production Sign Off

On Hold

Locked

10.3.1 Grey Sign Off icon: Not Signed Off

10.3.2 Yellow Sign Off icon: Partial Sign Off

10.3.3 Green Sign Off icon: Production Sign Off

10.3.4 Red Sign Off icon: On Hold

10.3.5 Black Padlock icon: Locked

10.4 Selection of the sign off icon displays screens to allow run sign off if the use has
privileges to do so.

11.0 Data Sheets

11.1 Data sheets provide a mechanism to record data. RZ administrative personnel configure
data sheets in the RZ Admin application. The behavior of a data sheet depends upon

configuration, but for most applications, data sheets require an electronic signature
upon completion. Configuration of data sheets often includes automatic initiation of a

data sheet based upon some event. Data sheets are often configured to initiate to a
specific area and are associated with a specific run. For example, a data sheet may

start when a production run starts. Data sheets may start at specific times or intervals

and may not be associated with a specific run. For example, a data sheet may be
initiated to record weekly checks. Operators may start data sheets manually as needed

by clicking the square pencil [/ where available.

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li Data sheets are visible and available in the following locations:

11.2.1 Main Screen > Activities

11.2.2 Main Screen > Operations — choose a specific location > Quality + Report

11.2.3 Main Screen Quality — Ellipsis e@e ona specific location > Pending

Data Sheets

11.2.4 See also “General Review Options” in this procedure for other ways to navigate

to a data sheet.

12.0 Data Sheet Types

12.1 There are three types of data sheets. The table below defines the behavior of each type.

Dats Shect Type Scori : ng method Qual I i n t c y l D u a de s d h b i o n ard | __ I O n f c f lu D d a e s d h i b n o a Si r g d n | M a u p s r t o d b u e c t l i in o k n e r d u t n o

Quality Check Pass / Fail Yes Yes Yes

Production Check Pass / Fail No No No

Audit Numeric Score No No No

12.2 Quality Check data sheets are associated with a production run and therefor a

production batch number. Quality Check data sheets include activities like a run startup
check, a run process check, etc.

12.3. Production Checks are not associated with a run. These checks are independent of a
specific production run or batch number and include activities like a scale daily check,

equipment calibration, or an environmental monitoring check.

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12.4 Audit data sheets are also independent of any specific production run or batch number.

The key difference for Audit data sheets compared to the other two data sheet types is

that Audit data sheets provide a score when completed.

13.0 Filters W

iis: bal RZ provides filters (see symbol in the title of this section) on many of the user interface

screens. The filter options vary depending upon the application; however, there are
common features across most applications of the filter icon.

13.2 After first selecting the filter icon:

13.2.1 A list of pre-defined and/or pre-saved filters is listed (as applicable)

13.2.2 A plus “+” sign in the top right provides the ability to add new filters

13.3.1 Set as default

13.3.2 Edit

13.3.3 Delete

13.3.4 Cancel (which backs out of the dialog brought up by selecting the ellipsis)

13.4 Selecting a pre-defined or pre-saved filter executes that filter,

13.5 Creating a new filter or editing an existing filter brings up a dialog with filter options.
Edit these options as needed. Pressing the play icon ( > ) in the upper right corner

allows for options like:

13.5.1 Save as Default and Run

13.5.2 Save and Run

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13.5.3 Run Only (which allows running without saving selected filter options)

13.5.4 Cancel (which backs out of the dialog brought up by selecting the play icon)

14.0 General Review Options

14.1 Under the “More” tab at the bottom of the main screen, RZ provides tools for searching

and reviewing data and data sheets collected in RZ. The sections below provide details

about these tools.

14.2 Historical Report Search

14.2.1 The historical report search tool allows the use of Filters to find and review Shift
Reports, Run Reports, and Quality Run Reports. This tool is available from the

following screen selection steps:

14.2.1.1 Main Screen — More — Historical Report Search

14.3. Data Sheet History

14.3.1 The data sheet history tool allows the use of Filters to look at historical data

across runs and based on specific data sheet templates. This tool is available

from the following screen selection steps:

14.3.1.1 Main Screen + More — Data Sheet History

14.4 SPC Report Search

14.4.1 The SPC report search tool allows the review of SPC data across runs in a

specific location for a specific product, and a specific characteristic. This tool is
useful for tracking performance of these parameters. This tool is available from

the following screen selection steps:

14.4.1.1 Main Screen + More — Data Sheet History

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15.0 Understanding the Data Sheet “Action” screen

15.1 The data sheet action screen is available as described for “Data Sheets” in this

procedure and is only available for unexecuted data sheets. Each data sheet has an

action screen before execution. At the top of the screen is a unique action number
assigned to that data sheet. The action number will remain with the data sheet after

execution and is a unique identifier. At the top of the action screen is a “Continue”
option. Selection of the continue option opens the data sheet for execution and allows

the user to enter data. The action screen summarizes details about the data sheet,
including:

15.1.1 Data sheet name

15.1.2 Data sheet due date (all data sheets have a due date and will close as “missed” if
not executed before that due date. The time frame given to complete a data

sheet is set up during data sheet configuration by an RZ admin)

15.1.3 Product Name and SKU (if applicable)

15.1.4 Run ID / Batch Number (if applicable)

15.1.5 Run Location (if applicable)

15.1.6 Comments, including references to linked datasheets (if applicable)

16.0 Understanding the “Data Sheet Results” screen and reports

16.1 The data sheet results screen is available as described for “Data Sheets” in this

procedure and is only available for fully executed data sheets. Each data sheet
generates a “Data Sheet Results” report after execution. The data sheet action number

is available in small print at the top of the data sheet. At the top of the screen are
options to “Retest” or “Void” the data sheet. This report summarizes details about the

data sheet, including:

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16.1.1 Product Name and SKU (if applicable)

16.1.2 Run ID / Batch Number (if applicable)

16.1.3 Run Location (if applicable)

16.1.4 Dates, times, and user associated with initiating, executing, authenticating, and

signing the data sheet

16.1.5 Data sheet results

16.1.6 Overall data sheet status (i.e. Pass, Warn, Fail, Cancel, Miss, and Void)

16.1.7 Comments and attachments along with the date, time, and user that added them

16.1.8 Links to other data sheets as applicable are included in the comments section.
RZ adds Links when one data sheet initiates another data sheet (e.g. a retest, ora

data sheet initiated by a trigger). These links are auto generated in the

comments section of the data sheet.

16.2 This screen is interactive, providing more detail and other screens upon selection of a

selection in the report screen.

17.0 Understanding the “Quality Run Summary” screen and reports

17.1 The quality run summary report is available from the following screen selection steps:

17.1.1 Main Screen — Operations > Operations Location > Quality — Report

17.1.2 Main Screen > Quality > Ellipsis ®@® on specific location > Quality Run

Summary

17.1.3 Main Screen — More — Historical Report Search — filter with “Quality Run

Report” option selected — select specific run

17.2 The top of the report identifies:

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17.2.1 The location that the run occurred in

17.2.2 The product name

17.2.3 The SKU for the product

17.2.4 The Run ID (i.e. batch number)

17.3. The beginning of the report summarizes (both graphically and in table format) the

number of each data sheet template started for the run in the following groupings:

17.3.1 Total

17.3.2 Pass — Green in graphical display

17.3.3 Warn — Orange in Graphical display

17.3.4 Fail — Red in graphical display

17.3.5 Cancel — Gray in graphical display

17.3.6 Void — Gray in graphical display

17.3.7 Miss — Black in graphical display

17.4 The rest of the report contains detail information for the run and data sheets initiated in

the run. This screen is interactive providing more detail and other screens upon
selection of a section in the report screen. For example, selection of s specific data sheet

will open the “Data Sheet Results” screen for that data sheet.

18.0 Electronic Signature

18.1 Before getting an RZ profile, you must complete form QS-116-F1 Electronic Signature

Acknowledgement and Consent by providing a handwritten signature on that form.

[SOP

Standard Operating Procedure SOP No | Rev Pusan
Redzone General Use c-111 i :

19.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 03/07/22 | New procedure. N/A K. Burris | - | - |
| 1 | 03/06/24 | Corrected typographical errors (OOE) in section 8.2.7.1. CC- | 24-0109 | K. Burris |