IVYAudit Questionnaire For Consulting Services Vendors

Audit Questionnaire for Consulting Service Vendor
DEPARTMENT: FORMAT NO.:
REF SOP NO.: PAGE:
1 GENERAL INFORMATION
QUESTION RESPONSE COMMENTS
1.1 Company Name
1.2 Year of establishment
1.3 Location/Address in current city
1.4 Does the Company have other locations? If response is

“Yes” then list the relevant locations with brief function
of each in the Comments section.
_________ (all locations)

1.5 No. of employees
_________ (this location)
1.6 Is the company currently involved in any litigation?

REF SOP NO.: PAGE:

1.7 Does the Company have any kind of certification (e.g. Certification:_____________________
ISO, etc.)? If response is “Yes” then list the certification. (Yes / No) _____________________________________
If “Yes” provide details of your most recent Certification _________________________
audit by your certification body (bodies).
1.8 How long has the company been involved with the Life
sciences Industry?
----------- years
1.9 What percentage of the company sales is attributed to

the Life sciences Industry?
----------- %
1.10 Does the Company have other locations? If response
is “Yes” then list the relevant locations with brief
function of each in the Comments section.
1.11 Is the company willing to sign a non-disclosure
agreement for the protection of Clients proprietary
information?
1.12 Have all persons who are/will be involved in the
software development, and having access to Clients
proprietary information, signed non-disclosure
agreements?
REF SOP NO.: PAGE:

1.13 Can you describe the measures that will be taken to
ensure the security and confidentiality of Client
proprietary information?
1.14 Can you supply a list of people who will have access to
client proprietary information including, documentation
and information located on servers/clients?
1.15 What is the protection against bankruptcy or the

discontinuance of any product? Do you supply source
code or is it through an escrow?
COMPLIANCE SUMMARY (TO BE COMPLETED BY AUDIT TEAM)

ACCEPTED (A) / CONDITIONAL ACCEPTANCE (CA) / FAILED (F)
COMMENTS / OBSERVATIONS
REF SOP NO.: PAGE:
2 ORGANIZATION AND PERSONNEL

2.1 Does the Company have a well-defined Management
structure where roles and responsibilities are clearly
defined and understood?
2.2 Provide organizational chart(s) giving the Company
structure, organization, and the responsibilities of key
individuals within the structure (from Managing Director
to personnel responsible for the delivery of the required
product/project).
2.3 Are new employees recruited according to job
descriptions and job specifications?
2.4 Is there an employee training procedure? Are all

employees trained in accordance with this procedure?
2.5 Are training records readily available? If so, are they up

to date for all employees?
2.6 Does the training include 21 CFR Part 11 and other
relevant industry standards? Does this training include
technical training, awareness training, and application
specific and regulatory training at a minimum?
REF SOP NO.: PAGE:

2.7 Does the Company have a mechanism in place to keep
abreast with changes in industry standards and
developments in technology sectors?
2.8 Does the Company conduct employee performance

evaluation and appraisal at regular intervals?
2.9 Does the training program enforce retraining at regular

intervals?
2.10 Does the Company use sub-contractors? (If the

response to this question is “Yes” respond to questions
2.10.1 to 2.10.3)
2.10.1 Does the company have a policy or procedure,
which they follow when they sub-contract work?
2.10.2 Does the company audit the subcontractor to
ensure that they meet the company’s technical
and quality requirements?
2.10.3 Are contractors trained on company’s policies
and procedures in accordance with training
guidelines?
REF SOP NO.: PAGE:

REF SOP NO.: PAGE:
3 INFRASTRUCTURE
3.1 Are the facilities maintained properly?
3.2 Does the facility have reliable power supply?
3.3 Does the facility have alternate power supply in case of

a power loss?
3.4 Are all systems connected to UPSes and/or Emergency

Power?
3.5 Is there a Fire Alarm and Extinguishing System in

place?
3.6 Are critical systems located in secure locations with

controlled access?
REF SOP NO.: PAGE:
3.7 Does the facility have the necessary licensed operating

system and application software?
3.8 Are all critical equipment covered under a maintenance

contract?
3.9 Does the facility have the necessary communication

infrastructure (phone, network, internet connections,
etc.)?

REF SOP NO.: PAGE:
4 SECURITY
4.1 Do you have written standards and procedures for

physical and logical system security?
4.2 Does the Company have a policy for assigning User

IDs and passwords, which defines procedure for
assigning passwords, assigning access levels,
changing passwords and retiring users?
4.3 Does the Company have a software anti-virus policy?
4.4 Is this policy properly communicated to the

employees?
4.5 Is anti-virus software installed on all servers and

workstations in the facility?
4.6 Is anti-virus software regularly updated for new virus

protection?
REF SOP NO.: PAGE:
4.7 Does the Company network have a firewall?
4.8 Is the firewall configured according to Company

security policy?
4.9 Are there internal security audit procedures to

ensure compliance?
4.10 Are there procedures to handle intrusion attempts
and security violations?

REF SOP NO.: PAGE:
5 DOCUMENT MANAGEMENT

5.1 Does the Company have a document management
policy?
5.2 Are all documents developed according to

documentation standards?
5.3 Are all documents indexed and organized?
5.4 Are all documents reviewed prior to approval and

issue?
5.5 Is access to documents and distributions of

documents controlled?
5.6 Are document histories maintained?
5.7 Are documents archived for future reference?

REF SOP NO.: PAGE:
5.8 Do all required documents have the appropriate

reviews and approvals?

REF SOP NO.: PAGE:
6 PROJECT PLANNING AND MANAGEMENT

6.1 Does the company use quality and project plans (plan
detail activities, responsibilities, processes, procedures
and timelines) for projects? If “Yes” provide a sample of a
recent project plan / quality plan.
6.2 Are these plans reviewed and updated regularly?
6.3 Is the project structure defined with responsibilities

identified?
6.4 Is there a list of deliverables that will be produced for each
project?

Completed By (Auditor 1)
REF SOP NO.: PAGE:
Name: Signature: Date:
Completed By (Auditor 2)
Name: Signature: Date:
Remarks:_____________________________________________________________________________________________________________
_____________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
Prepared By (IT): Reviewed by (QA): Reviewed By (CQA): Approved By (QA):
Name: Name: Name: Name:
Signature: Signature: Signature: Signature:
Date: Date: Date: Date:

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IVYAudit Questionnaire For Consulting Services Vendors

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Audit Questionnaire for Consulting Service Vendor

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

1.1 Company Name

1.2 Year of establishment

1.3 Location/Address in current city

1.4 Does the Company have other locations? If response is

_________ (all locations)

1.6 Is the company currently involved in any litigation?

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

1.9 What percentage of the company sales is attributed to

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

1.15 What is the protection against bankruptcy or the

COMPLIANCE SUMMARY (TO BE COMPLETED BY AUDIT TEAM)

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

2 ORGANIZATION AND PERSONNEL

QUESTION RESPONSE COMMENTS

2.4 Is there an employee training procedure? Are all

2.5 Are training records readily available? If so, are they up

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

2.8 Does the Company conduct employee performance

2.9 Does the training program enforce retraining at regular

2.10 Does the Company use sub-contractors? (If the

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

COMPLIANCE SUMMARY (TO BE COMPLETED BY AUDIT TEAM)

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

3.1 Are the facilities maintained properly?

3.2 Does the facility have reliable power supply?

3.3 Does the facility have alternate power supply in case of

3.4 Are all systems connected to UPSes and/or Emergency

3.5 Is there a Fire Alarm and Extinguishing System in

3.6 Are critical systems located in secure locations with

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

3.7 Does the facility have the necessary licensed operating

3.8 Are all critical equipment covered under a maintenance

3.9 Does the facility have the necessary communication

COMPLIANCE SUMMARY (TO BE COMPLETED BY AUDIT TEAM)

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS

4.1 Do you have written standards and procedures for

4.2 Does the Company have a policy for assigning User

4.3 Does the Company have a software anti-virus policy?

4.4 Is this policy properly communicated to the

4.5 Is anti-virus software installed on all servers and

4.6 Is anti-virus software regularly updated for new virus

DEPARTMENT: FORMAT NO.:

REF SOP NO.: PAGE:

QUESTION RESPONSE COMMENTS