CLEAN ROOM DATA SHEET

A document created by the manufacturer of a device that

provides detailed installation and operation instructions.

Unitech Instrument
Vadodara
Ph: 0265-66235
CLEAN ROOM DATA SHEET

Foods &
Power Plants
Beverages

Textile Plants Cold Storage

Report
Calibration

Validation

Testing

Pharmaceutical Steel Plants

Petrochemical

Main Features:-
 ONLINE & LOGGED DATA
 ALARM REPORT
 AUDIT TRAIL REPORT
 EASY AND INTUITIVE SUPERVISION SOFTWARE
 MULTIPLE INSTRUMENTS APPLICATION
 VARIOUS COMBINATION OF GRAPGS
 REPORT AND GRAPH CAN E-MAIL BY THE SOFTWARE

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Report, Graph and Channel Information:-

Classics Features:-
 Runs under all current Windows versions (XP/VISTA/Windows 7)
 Easy to set-up and use.
 Real time data collection, analysis and display.
 Programmable alarm limits can be set for each Channel.
 Data report can be exported to PDF format.
 Can be used with desktop computers or laptops.
 Supports multiple loggers/indicators on the same PC.
 Trends or graphs can be saved, printed and E-mail from your PC.
 Simultaneously 3-loops can run using Ethernet port, Serial port and USB.

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CLEAN ROOM DATA SHEET

Applications:-
 Pharmaceutical
 Formulations
 Clinical Trials
 Bulk Storage
 Green Houses

Channel View:-

It shows data which are coming from instruments. It shows peak value and set-point value and
alarms raised for particular instrument in the channel.

Report View:-

It shows the data report of instruments using data from database based on instruments
selection.

Graph View:-

It shows trends for logged data using data from database based on instrument selection and
also shows online trends for instruments which are connected to the software.

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CLEAN ROOM DATA SHEET

Connection Establishment and Monitoring Room:-

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Note: Information presented in this document assumes that the appropriate Universal Software
Policies have been configured for Electronic Record (ER) and Electronic Signature (ES) support.

Overview Yes/No/NA

Is the system a Closed System, where system access is controlled by the persons
who are responsible for the content of the electronic records that are on the Yes
system?
Is the system an Open System, where system access is not controlled by the
persons who are responsible for the content of the electronic records that are on No
the system?

Does the system use a username/ password combination? Yes

Does the system use biometrics? No

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21 CFR Parts 11 Requirements Followed in UNIVERSAL SOFTWARE

Ref. Yes/NA/No Explanation

Subpart B – Electronic Records 11.10 Controls for Closed Systems

1 11.10 (a) Is the system validated?
Does the validation
documentation show that Part 11
2 11.10 (a)
requirements have been met and
are functioning correctly?
Is the system able to detect invalid
records where applicable (e.g.
3 11.10 (a) invalid field entries, fields left
blank that should contain data,
values outside of limits)?
Is it possible to view the entire
4 11.10 (b)
contents of the records?
Is it possible to print the entire
5 11.10 (b)
contents of the records?
Is it possible to generate all the
records electronically in a format
6 11.10 (b) that can be put on a portable
medium (e.g. diskette or CD) or
transferred electronically?
Are records protected against
7 11.10 (c) intentional or accidental
modification or deletion?
Are there different levels of access
based on user responsibilities (e.g.
8 11.10 (d) user, administrator) (if
appropriate)? Is this documented
and controlled?
UNITECH INSTRUMENTS has structurally
Yes
validated Universal software.
Universal software allows users to be
Yes
compliant with 21 CFR Part 11.
Yes
Yes
Yes
Yes
The abilities to modify or delete data within
the Universal software application are
Yes specifically assigned privileges. All actions
involving a creation, deletion or
modification of data is audit trailed.
User access is based on the concept of
“User Types”. A user type defines a specific
level of access based on allowed
activities/responsibilities. Changes to user
Yes types are documented in the system audit
trail. The ability to create, modify or delete
user types are discrete privileges that may
be assigned to specific individuals.

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Are user access levels approved by
9 11.10 (d) management or the system owner
before assignment to a user?
Is there is a controlled,
documented process for granting
10 11.10 (d) access to a new user, for changing
privileges for an existing user and
for deleting user accounts?
Is there physical security and
procedures to protect database
11 11.10 (d)
and system components from
unauthorized access?
Is an electronic audit trail function
12 11.10 (e) automatically generated for all
operator entries?
Is the audit trail completely
13 11.10 (e) outside the control and access of
users?
Is it impossible to disable the audit
14 11.10 (e)
trail function?
Is the system date and time
15 11.10 (e) protected from unauthorized
change?
Can time stamped audit trail be
16 11.10 (e)
viewed and printed by inspectors?
Can time stamped audit trail be
extracted in a transportable
17 11.10 (e)
electronic format that can be read
by regulatory agencies?
If no audit trail is available, can the
18 11.10 (e)
system detect that a record was
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User access levels are set and approved
during the process of creating a user. Only
an individual who has explicitly been given
Yes
the privilege to create or alter a user
account can change the access level for a
particular user.
User creation, modification and deletion are
controlled through a software wizard, and is
Yes
only accessible to appropriately privileged
users.
Each organization must develop a
NA controlled, documented procedure for
managing system security and protection.
All activities for all users in system will be
Yes audit trailed, with no user types or activities
treated differently.
A designated system administrator may
Yes configure audit trail settings, no other users
will have control over audit trails.
The system audit trail cannot be disabled.
Software data is stored in Projects and it is
Yes
impossible to disable or modify audit trail
settings for a project after its creation.
The system date and time are taken from
the computer operating system. The ability
to change the system date and time is a
NA
privilege that is controlled through the
computer operating system and not
through the Universal Software.
Audit trails are available in Universal
Software that can be filtered by time and
Yes
can be archived for storage or offsite
inspection.
The audit trail can be backed up to different
Yes
file formats like pdf, doc, xls, rtf and rpt.
Audit trails are available in the database.
NA
Alteration of information creates new
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altered since its last approval?
Are operator name, date, time,
and indication of record (or file)
19 11.10 (e)
creation, modification or deletion
recorded in audit trail?
If the system requires sequenced
steps, does it ensure that the
20 11.10 (f)
actions are performed in the
correct sequence?
Does the system ensure that only
21 11.10 (g) authorized individuals can use the
system?
If it is a requirement of the system
that data input or instructions can
only come from specific input
22 11.10 (h)
devices (e.g. instruments,
terminals); does the system check
for the correct device?
Persons who develop the system
have the education, training and
23 11.10 (i)
experience to perform their
assigned tasks?
Is there documentation to show
that persons who maintain or use
24 11.10 (i) the system have the education,
training and experience to
perform their assigned tasks?
Is there a written policy in place
and enforced that holds
25 11.10 (j) individuals fully accountable and
responsible for actions initiated
under their electronic signatures?
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values that are stored in the database.
Records are not overwritten and full audit
trails are available to document changes.
This will require calling UNITECH
INSTRUMENTS and help from the UNITECH
INSTRUMENTS development team.
Yes
Universal software uses Wizards to ensure
Yes
proper sequencing.
In order to access the Universal Software,
individuals must have a user account. This
Yes account will define the capabilities that user
will have on the system. Without an
account, no access to the system is allowed.
System designates appropriate input based
on user authentication, and not device
authentication. Raw data may only come
from a device on which System has been
NA
configured. Other instructions may only
come from devices on which system
database access has been configured and
enabled.
UNITECH INSTRUMENTS has all information
Yes
about development persons.
Each organization must develop controlled,
NA documented procedures for compliance
with this requirement.
Each organization must develop controlled,
NA documented procedures for compliance
with this requirement.
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Is the distribution of, access to,

Each organization must develop controlled,
and use of systems operation and
26 11.10 (k) NA documented procedures for compliance
maintenance documentation
with this requirement.
controlled?
Is access to “sensitive” systems
Each organization must develop controlled,
documentation restricted e.g.,
27 11.10 (k) NA documented procedures for compliance
network security documentation,
with this requirement.
system access documentation?
Is there a Change Control SOP Each organization must develop controlled,
28 11.10 (k) governing revisions to system NA documented procedures for compliance
documentation? with this requirement.

11.30 Controls for Open Systems

What controls ensure record
29 11.30 authenticity, integrity, and NA Universal software is a closed system.
confidentiality?
30 11.30 Is data encrypted? NA Universal software is a closed system.
31 11.30 Are digital signatures used? NA Universal software is a closed system.

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11.50 Signature Manifestations

Do all electronically signed records
contain the following information
The user must configure the full name of
32 11.50 (a) associated with the signing: Full Yes
the signer for it to appear on the report.
printed name of the signer

Do all electronically signed records

contain the following information
33 11.50 (a) Yes
associated with the signing: Date
and time of signing
Are the date and time stamps
34 11.50 (a) applied automatically (vs. being Yes
keyed in by the user)?
Are date and time stamps derived
Date and time stamps are the local date and
in a consistent way in order to be
35 11.50 (a) Yes time at the location where the signature
able to reconstruct the sequence
was executed.
of events?
Is the above information subject
to the same controls as electronic The audit trail keeps track for this to occur
36 11.50 (b) Yes
records? (audit trails, access in the project.
control etc.)
Signatures may not be altered; new
Are changes to signatures included
37 11.50 (b) Yes signatures may be added to a record and
in the audit trail?
are fully audit trailed.
Do the printed name, date and Electronic records are shown in human
time appear in every human readable form in report section and in
38 11.50 (b) readable form of the electronic Yes printed reports. A table of electronic
record? (e.g. all screens and signatures can be placed on reports that are
printed reports) used to view electronic records.

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11.70 Signature/Record Linking

Handwritten signatures are not executed to
If handwritten signatures are
electronic records. Handwritten signatures
executed to electronic records, are
39 11.70 NA may be executed to a printed report, and
the handwritten signatures linked
such a report may include information
to the electronic record(s)?
identifying the original electronic record.
If the electronic record is changed,
All changes to an electronic record are audit
is the signer prompted to re-sign
40 11.70 Yes trailed in the universal software in which
(via either manual procedures
the record is stored.
(SOP) or technical means)?
Are the E-signatures linked to their
corresponding electronic records
to ensure that the signature
41 11.70 Yes
cannot be copied, or otherwise
transferred to falsify an electronic
record by ordinary means?

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Subpart C – Electronic Signatures 11.100 General Requirements

Is each E-signature unique to one
42 11.100(a) Yes
individual?
Are E-signatures ever reused by,
43 11.100(a) or reassigned to, anyone other No
than the original owner?
Is the individual identified
Each organization must develop controlled,
adequately verified prior to
44 11.100(b) NA documented procedures for compliance
issuance of an electronic
with this requirement.
signature?
Is there a procedure for reissuing Each organization must develop controlled,
45 11.100(b) forgotten passwords that verifies NA documented procedures for compliance
the requestor's identity? with this requirement.
Has certification of the intent to
use electronic signatures been Each organization must submit their written
46 11.100(c) submitted to the agency in paper NA intent for compliance with this
form with a traditional requirement.
handwritten signature?
Can additional certification or
testimony be supplied to show Each organization must develop their
47 11.100(c) that an electronic signature is the NA controlled, documented procedure for
legally binding equivalent of the compliance with this requirement.
signers handwritten signature?

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11.200 Electronic Signature Components and Controls

Is the signature made up of at
least two distinct identification
48 11.200(a)
components, such as an
identification code and password?
If continuous signing sessions are
used, are two (or more) E-
49 11.200(a)
signature components required
for the initial signing?
Are non-biometric signatures only
50 11.200(a)
used by their genuine owners?
Are non-biometric signatures
administered and executed so that
51 11.200(a) unauthorized use requires the
collaboration of two or more
individuals?
Are biometric E-signatures
designed to ensure that they can
52 11.200(b)
be used only by their genuine
owners?
A signature comprises a user name and a
Yes
password.
The user name and password are required
Yes
for the initial signing.
Each organization must develop its own
NA controlled, documented procedure for
compliance with this requirement.
Each organization must develop their
NA controlled, documented procedure for
compliance with this requirement.
Universal software does not use biometric
NA
E-signatures.

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11.300 Controls for Identification Codes/Passwords

Are controls in place to maintain
the uniqueness of each combined Universal Software Policies can be set to
identification code and password, ensure that there must be unique
53 11.300(a) Yes
such that no two individuals can combination of user names and passwords
have the same combination of used on the system.
identification code and password?
Universal Software Policies can be used to
Are controls (procedural or ensure that passwords may not be reused
54 11.300(a) technical) in place to prevent the Yes
for individual user accounts, and that user
re-use of identification codes?
names cannot be reused for multiple users.
System allows a user account to be
Is there a procedure for recalling removed from active use. Each organization
identification codes and
55 11.300(b) Yes must develop controlled, documented
passwords if a person leaves or is
procedures to ensure proper notification of
transferred?
user status changes.
Is a SOP in place directing action to
be taken to electronically
deauthorize lost, stolen, missing,
or otherwise potentially System does not use tokens, cards or other
56 11.300(c) NA
compromised tokens, cards, and devices to carry E-signature components.
other devices used to carry or
generate E-signature
components?
Does this SOP contain procedures
for managing and controlling System does not use tokens, cards or other
57 11.300(c) NA
temporary or permanent token/ devices to carry E-signature components.
card replacements?
When an invalid login attempt is made, an
Are any attempts to unauthorized
58 11.300(d) Yes immediate notification is displayed on the
use detected?
consoles of the system
Are there procedures covering the
initial and periodic testing of
devices, such as tokens or cards System does not use tokens, cards or other
59 11.300(e) NA
that bear or generate devices to carry e-signature components.
identification code or password
information?
Does the testing include checks for
proper functioning, performance System does not use tokens, cards or other
60 11.300(e) NA
degradation, and possible devices to carry e-signature components.
unauthorized alteration?

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