C-107

Redzone Reviewer Activities

Section C — Record Management Revision 0 8 pages

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1.0 Purpose

The purpose of this procedure is to define the review and signoff requirements for Redzone
data sheets and runs.

2.0 Scope

This procedure only applies to data sheets and runs associated with cGMP activities. This
procedure does not cover the review of paper documents or documents generated by systems

other than Redzone.

3.0 Responsibility

3.1 It is the responsibility of all employees engaged in RZ review and signoff activities (i.e.

people with “Quality Sign Off Permission” set to “Data Sheet” or “Run”) to comply
with this procedure.

3.2 ‘It is the responsibility of Quality Management to maintain this procedure to ensure that
it reflects current practices.

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

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application.

4.4 Backend Application — The backend application provides tools to set user permissions,

define locations to use RZ, define products and associated characteristics, define shifts,
define data sheets, 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 Data Sheet — Unless explicitly stated otherwise, a data sheet is an RZ component of the
RZ Compliance Module that is configured in RZ Admin and used in Redzone to collect

data.

4.7 SPC — Statistical Process Control; A method of measuring and controlling quality by
monitoring the manufacturing process. Quality measurements recorded in data sheets

are evaluated against statistical control rules to identify trends before data is out of
specified limits.

4.8 Handwritten Signature — Handwritten signature means the scripted name or legal
mark of an individual handwritten by that individual and executed or adopted with the

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.

4.9 Digital Signature — Digital signature means an electronic signature based upon

cryptographic methods originator authentication that is computed by using a set of rules
and a set of parameters such that the identity of the signer and the integrity of the data

can be verified.

4.10 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.

4.11 Electronic Signature — Electronic signature means a computer data compilation of any

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symbol or series of symbols executed, adopted, or authorized by an individual to be the
legally binding equivalent of the individual’s handwritten signature.

4.12 cGMP — Current Good Manufacturing Practices

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

4.14 SOP - Standard Operating Procedure

5.0 References

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

5.2 C-111, SOP, Redzone General Use

6.0 Procedure

6.1 Overview

6.1.1 Ion Labs uses RZ data sheets to replace logbooks and forms used by

conventional paper-based systems. RZ is capable of automating the initiation of

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

requirements.

6.1.2 This procedure covers the review and sign off process for RZ data sheets and

runs. RZ data sheets are initiated automatically or manually depending upon the
process. RZ data sheets may be associated with a production run (e.g. run

startup check, run process check, etc.) or may be independent of a specific

production run (e.g. scale daily check, environmental monitoring check, audit
check, etc.). most data sheets require authentication (i.e. digital signature) from

the user finalizing the data sheet. This is equivalent to a “done by” handwritten
signature. The design of some data sheets include the check of activities

performed previously. Authentication of these activities is equivalent to a
“verified by” handwritten signature. The design of some data sheets may

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require reviews and send out review notifications. This is equivalent to a
“reviewed by” handwritten signature. The RZ run sign off process also

documents reviews and review signatures.

6.1.3 Ion Labs uses RZ to track each production run. Operators start a RZ shift and, a

RZ run where they enter the production Batch Number as the RZ Run ID. Data

sheets initiated as applicable throughout the run are available for review and
signoff as defined in this procedure.

6.1.4 Standard Operating Procedures (SOPs) control the use of RZ data sheets.
Process specific SOPs may provide details about the use of RZ data sheets and

review requirements. Process specific SOPs override any general RZ SOP
requirements that conflict with those more specific SOPs. Use the frontend

Redzone application to complete activities associated with this procedure.

6.2 RZ Knowledge Base

6.2.1 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.

6.3 Review for Good Documentation Practices (GDP)

6.3.1 RZ data sheets used in cGMP runs are electronic records used to capture cGMP

activities. RZ provides the ability to correct, (i.e. “retest”) a data sheet to correct

entries. RZ also provides mechanisms to cancel a data sheet, and void a data
sheet. These activities require appropriate comments and/or corrective actions

unless the reason is obvious. If a RZ data sheet design includes a trigger to
initiate another data sheet to address one of these issues, that additional data

sheet may provide the necessary information and avoid the need for a comment.

6.4 Review Exceptions

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6.4.1 RZ graphical displays of data sheet status (i.e. Pass, Warn, Fail, Cancel, Miss,
and Void) makes it easy to identify data sheets with an exception that would

require a more critical review. Consider all data sheets with a status other than
“Pass” a data sheet that warrants a critical review unless the design of the data

sheet expects these status conditions as part of the process.

6.5 Review Corrective Actions

6.5.1 Review of exceptions may identify the need for corrective actions. Review

corrective actions and ensure that actions taken are appropriate.

6.6 Run sign off process §

6.6.1 The remainder of this procedure provides sections that describe specific aspects

of the run signoff process. Each run requires sign off before release of product
associated with that run or before release of the associated activity (e.g. a

cleaning run). Before signing off on a run, ensure that associated data sheets are
reviewed and compliant. If necessary, have corrections or comments added

before completing final signoff.

6.7 Run sign off options and status §

6.7.1 RZ provides three levels of Sign Off described here:

6.7.1.1 Sign Off - This option can apply to portions of the run or the entire
run. It indicates that review is complete and acceptable for data sheets

with this status. It is possible to change this status to either “On Hold”
or “Lock”

6.7.1.2 On Hold - This option can only apply to the entire run. It indicates that
the run is not suitable for release until additional action is completed.

It is possible to change the status to Lock, but it is not possible to

change the status back to Sign Off

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6.7.1.3 Lock - This option can only apply to the entire run. The system does
not allow further sign off status changes once a run is “locked”

6.7.2 Redzone changes the color of the Run Sign Off icon (see symbol in the title of
this section) displayed next to any given run based on the sign off status (see

color picture below with color description if printed in black and white).

6.7.2.1 Grey Sign Off Icon: Not Signed Off

6.7.2.2 Yellow Sign Off Icon: Partial Sign Off

6.7.2.3. Green Sign Off Icon: Production Sign Off

6.7.2.4 Red Sign Off Icon: On Hold

6.7.2.5 Black Padlock Icon: Locked

Not Signed Off

Partial Sign Off

Production Sign Off

On Hold

Locked

Note: Comments are available for addition to the run or individual data sheets

regardless of run signoff status.

6.8 Access to the “Sign Off Dashboard” and “Run Sign Off’ Screens

6.8.1 The “Sign Off Dashboard” provides a list of all runs yet to be “locked.” The

“Run Sign Off’ screen provides sign off options for specific runs. The
following steps provide access to these screens:

6.8.1.1 Access the “Quality Dashboard” from the “Quality” tab at the bottom
of the main screen.

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6.8.1.2 Select the Run Sign Off icon ( 4 ) form the Quality dashboard. Select

a specific run or multiple runs to access the “Run Sign Off” screen.

6.8.1.3 Select the “More” tab at the bottom of the main screen and then select

“Sign Off Dashboard.” Select a specific run or multiple runs to access

the “Run Sign Off” screen.

6.8.1.4 Select the “More” tab at the bottom of the main screen and then select

“Historical Report Search.” Apply an appropriate filter and navigate to
the run of interest. If the run is not already “locked,” the Quality Run

Summary screen provides a “Sign Off” option at the top of the screen.

This method does not provide access to the Sign Off Dashboard, but
does navigate to the “Run Sign Off” screen for a specific run.

6.9 Run Sign Off Steps

6.9.1] After selecting a run or multiple runs to sign off, proceed to review the data

sheets associated with the run. See other sections of this procedure for details
and requirements for reviewing data sheets. Select one or more data sheets to

sign off and select the appropriate sign off option (i.e. Sign Off, Hold, or Lock)
and then choose “Sign Off’ to complete the process. The system will ask for

“Sign Off Authentication” for you to provide your username and Pin or

Password. After authentication, the selected data sheets and runs contain the
updated sign off status and identifies the user completing the signoff function.

6.10 Export ch

6.10.1 RZ provides export capabilities (see export icon in the title of this section) on
many of the user interface screens. After selecting the export icon a dialog

screen appears with export options. These options may vary depending upon
applications installed on the device, but should include Copy, Markup, Print,

and Save to Files among other options. Choose the appropriate tool and follow

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additional prompts as applicable. Other Ion Labs SOPs may require export or
printing of RZ reports or data sheets in specific formats or using specific tools.

Note: It is possible to configure one or more email address to receive a “Quality Run
Summary” report after a Run Sign Off “Lock” activity is complete. This is the

same as exporting the report to an email.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 03/14/22 | New procedure. N/A K. Burris | - | - |