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21 CFR Part 11 System Assessment and Gap Analysis

Section 1: General Information


1
Response may be Yes (Y), No (N), or Not Applicable (N/A). All responses require some statement regarding the objective evidence or rationale for the
response, particularly answers marked N/A.
2
Control Type refers to the type of control that currently exists: Procedural (P), or Technical (T). Both may be checked if appropriate.

1. Date: 06 MAY 2010 2. Assessor Name(s):

3. System Name: Learning Management System (LMS) 4. System Owner:

5. System Version Number: Learner Web Enterprise (LWE) 6. Owner Department: WW Human Resources

7. Corp. System ID Number: Fixed Asset #_____ 8. IT Group Name: Information Services

9. Date Placed into Production: N/A – plan is October, 2010 10. IT Contact Name:

11. Previous Released Version(s)? Y N 12. If “Yes”, Version number(s) and date(s) released: N/A

13. Developed In-House Purchased Both 14. If “Purchased” or “Both”, Vendor’s Name: MaxIT

15. System Description / Comments 16. # of Users (Total): 500


LearnerWeb Enterprise features electronic signatures. It will facilitate
delivery of training and paperless retention of training records for all 17. # of Users (Simultaneous): 50
employees worldwide.

18. Departments / Areas Using System: All

19. (Server) Hardware Platform and Operating System: Windows 2003


Operating System, IIS v6 Web Server, SQL 2005 Database
20. Client Hardware and Operating System (if applicable): N/A – Application is
web-based.

Form GEN.164F2 GEN.164 Rev Rev 03/16/2009 Page 1 of 16


21 CFR Part 11 System Assessment and Gap Analysis

Section 2: General Questions Related to Applicability of 21 CFR Part 11

No. Question Response Instructions


1. What FDA regulation(s), i.e., Predicate Rule(s), apply to GMP GLP GCP QSR If “None” is checked then stop here, 21
this system? CFR Part 11 does not apply to this
Other: __________________ None system.
(specify)
If any other response is checked, then
respond to all remaining questions in
this section.
2. Does (for existing), or will (for new), the system contain Yes No Not Sure If “Yes” or “Not Sure” is checked
electronic records as defined in 11.3(b) (6)? complete Section 3 of this
questionnaire.

If “No” is checked then stop here, 21


CFR Part 11 does not apply to this
system.
3. Is the system (for existing), or will the system be (for new), Open Closed Not Sure If “Open” or “Not Sure” is checked
an Open or Closed system as defined in 11.3(b) (4) and complete Section 4 of this
(9)? questionnaire.

If “Closed” is checked, then continue.


4. Does (for existing), or will (for new), the system use Yes No Not Sure If “Yes” or “Not Sure” is checked
electronic signatures as defined in 11.3(b) (7)? complete Section 5 of this
questionnaire.

Form GEN.164F2 GEN.164 Rev Rev 03/16/2009 Page 2 of 16


21 CFR Part 11 System Assessment and Gap Analysis

Section 3: Questions Related to Electronic Records

Objective Evidence / Rationale


No. Question / Area of Analysis Part 11 Ref. Response1 Control Type2
/ Remediation Options
1. Has the system been validated “to 11.10(a) Y N N/A T P This requirement will be validated in
ensure accuracy, reliability, and accordance with SOP GEN.149 –
consistent intended performance, and Computer System Validation prior to
the ability to discern invalid or altered use.
records”?
2. Can the system generate accurate and 11.10(b) Y N N/A T P This requirement will be validated in
complete copies of records in human accordance with SOP GEN.149 –
readable form for FDA review? Computer System Validation prior to
use.
3. Can the system generate accurate and 11.10(b) Y N N/A T P This requirement will be validated in
complete copies of records in electronic accordance with SOP GEN.149 –
form for FDA review? Computer System Validation prior to
use.
4. If allowed by the Predicate Rule(s), are Y N N/A T P This requirement will be validated in
copies of records made by the system accordance with SOP GEN.149 –
accurate and complete copies of the Computer System Validation prior to
originals? use.
5. Is the retention period for records, or 11.10(c) Y N N/A T P
each type of record, in the system
defined?
6. Are records protected to enable their 11.10(c) Y N N/A T P
accurate and ready retrieval throughout
their retention period?
7. Does this system manage any data Y N N/A T P
defined as “raw data”, regardless of
whether that data is kept in paper or
electronic form?
8. If the answer to question 7. is “Yes”, is 11.10(c) Y N N/A T P
the raw data kept for the defined
retention period?

Form GEN.164F2 GEN.164 Rev Rev 03/16/2009 Page 3 of 16


21 CFR Part 11 System Assessment and Gap Analysis

Section 3: Questions Related to Electronic Records

Objective Evidence / Rationale


No. Question / Area of Analysis Part 11 Ref. Response1 Control Type2
/ Remediation Options
9. Is access to the system limited to 11.10(d) Y N N/A T P This requirement will be validated in
authorized individuals? accordance with SOP GEN.149 –
Computer System Validation prior to
use.
10. Is information on system security 11.10(d) Y N N/A T P
authorizations kept for the same
retention period required for the
electronic records to which those
authorizations apply?
11. Are controls in place for deactivating a 11.10(d) Y N N/A T P This requirement will be validated in
user’s access to the system, or accordance with SOP GEN.149 –
changing a user’s security level, for Computer System Validation prior to
circumstances such as: changing use.
responsibilities, changing departments,
termination (employees or contractors)?
12. Are controls in place for periodically 11.10(d) Y N N/A T P
reviewing (e.g., annually) who has
access to the system and what system
privileges they have?
13. Does the system documentation 11.10(d) Y N N/A T P This requirement will be validated in
describe the various levels of access accordance with SOP GEN.149 –
that can be given to each user? Computer System Validation prior to
use.
14. Are controls in place for re-issuing 11.10(d) Y N N/A T P Access will be controlled via Active
passwords (e.g., when a user has Directory (AD), so the control will be the
forgotten a password)? same as for the user’s network
password.
15. Are controls in place for locking and 11.10(d) Y N N/A T P
unlocking a user’s account?

Form GEN.164F2 GEN.164 Rev Rev 03/16/2009 Page 4 of 16

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