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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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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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

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

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User access levels are set and approved

during the process of creating a user. Only
Are user access levels approved by
an individual who has explicitly been given
9 11.10 (d) management or the system owner Yes
the privilege to create or alter a user
before assignment to a user?
account can change the access level for a
particular user.
Is there is a controlled,
User creation, modification and deletion are
documented process for granting
controlled through a software wizard, and is
10 11.10 (d) access to a new user, for changing Yes
only accessible to appropriately privileged
privileges for an existing user and
users.
for deleting user accounts?
Is there physical security and
Each organization must develop a
procedures to protect database
11 11.10 (d) NA controlled, documented procedure for
and system components from
managing system security and protection.
unauthorized access?
Is an electronic audit trail function All activities for all users in system will be
12 11.10 (e) automatically generated for all Yes audit trailed, with no user types or activities
operator entries? treated differently.
Is the audit trail completely A designated system administrator may
13 11.10 (e) outside the control and access of Yes configure audit trail settings, no other users
users? will have control over audit trails.
The system audit trail cannot be disabled.
Is it impossible to disable the audit Software data is stored in Projects and it is
14 11.10 (e) Yes
trail function? 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
Is the system date and time
to change the system date and time is a
15 11.10 (e) protected from unauthorized NA
privilege that is controlled through the
change?
computer operating system and not
through the Universal Software.
Audit trails are available in Universal
Can time stamped audit trail be Software that can be filtered by time and
16 11.10 (e) Yes
viewed and printed by inspectors? can be archived for storage or offsite
inspection.
Can time stamped audit trail be
extracted in a transportable The audit trail can be backed up to different
17 11.10 (e) Yes
electronic format that can be read file formats like pdf, doc, xls, rtf and rpt.
by regulatory agencies?
If no audit trail is available, can the Audit trails are available in the database.
18 11.10 (e) NA
system detect that a record was Alteration of information creates new

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altered since its last approval? 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.
Are operator name, date, time,
and indication of record (or file)
19 11.10 (e) Yes
creation, modification or deletion
recorded in audit trail?
If the system requires sequenced
steps, does it ensure that the Universal software uses Wizards to ensure
20 11.10 (f) Yes
actions are performed in the proper sequencing.
correct sequence?
In order to access the Universal Software,
Does the system ensure that only individuals must have a user account. This
21 11.10 (g) authorized individuals can use the Yes account will define the capabilities that user
system? will have on the system. Without an
account, no access to the system is allowed.
System designates appropriate input based
If it is a requirement of the system on user authentication, and not device
that data input or instructions can authentication. Raw data may only come
only come from specific input from a device on which System has been
22 11.10 (h) NA
devices (e.g. instruments, configured. Other instructions may only
terminals); does the system check come from devices on which system
for the correct device? database access has been configured and
enabled.
Persons who develop the system
have the education, training and UNITECH INSTRUMENTS has all information
23 11.10 (i) Yes
experience to perform their about development persons.
assigned tasks?
Is there documentation to show
that persons who maintain or use Each organization must develop controlled,
24 11.10 (i) the system have the education, NA documented procedures for compliance
training and experience to with this requirement.
perform their assigned tasks?
Is there a written policy in place
and enforced that holds Each organization must develop controlled,
25 11.10 (j) individuals fully accountable and NA documented procedures for compliance
responsible for actions initiated with this requirement.
under their electronic signatures?

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

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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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