Support
Have a question not answered here? Email us by filling out the form on our Contact
page.
|
| Training Tracker 5.0 and FDA Requirements
|
|
Training Tracker 5.0 has NOT been certified by the Food and
Drug Administration.
Computer Directions has never requested or attempted to obtain FDA certification.
If you are looking for a low cost, easy to use software that will assist
you in maintainig "printed paper" reports that CAN be used to
meet FDA regulations, then Training Tracker works well!
You can read below how Training Tracker 5.0 does meet many FDA Requirements.
Below we have quoted sections of federal documents and discus how Training
Tracker is designed to meet the requirements.
WAIS Document Retrieval[Code
of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.1]
[Page 119]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart A--General Provisions
Sec. 11.1 Scope.
(a) The regulations in this part set forth the criteria under
which the agency considers electronic records, electronic signatures,
and handwritten signatures executed to electronic records to be
trustworthy, reliable, and generally equivalent to paper records
and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted,
under any records requirements set forth in agency regulations.
This part also applies to electronic records submitted to the agency
under requirements of the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act, even if such records are not specifically
identified in agency regulations. However, this part does not apply
to paper records that are, or have been, transmitted by electronic
means.
(c) Where electronic signatures and their associated electronic
records meet the requirements of this part, the agency will consider
the electronic signatures to be equivalent to full handwritten signatures,
initials, and other general signings as required by agency regulations,
unless specifically excepted by regulation(s) effective on or after
August 20, 1997.
(d) Electronic records that meet the requirements of this part may
be used in lieu of paper records, in accordance with Sec. 11.2,
unless paper records are specifically required.
(e) Computer systems (including hardware and software), controls,
and attendant documentation maintained under this part shall be
readily available for, and subject to, FDA inspection.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.10]
[Page 120-121]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart B--Electronic Records
Sec. 11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate,
the confidentiality of electronic records, and to ensure that the
signer cannot readily repudiate the signed record as not genuine.
Such procedures and controls shall include the following:
(a) Validation of systems to ensure accuracy, reliability, consistent
intended performance, and the ability to discern invalid or altered
records.
(b) The ability to generate accurate and complete copies of records
in both human readable and electronic form suitable for inspection,
review, and copying by the agency. Persons should contact the agency
if there are any questions regarding the ability of the agency to
perform such review and copying of the electronic records. |
Training Tracker allows reports to be printed on paper and these reports
can be exported to multiple electronic formats including ASCII Text and
HTML formats.
(c) Protection of records to
enable their accurate and ready
retrieval throughout the records retention period |
Training Tracker stores records in a database. The database can be quickly
and easily backed up (unlike paper documents) providing "Protection
of records".
| (d) Limiting system access to
authorized individuals. |
Access is limited to persons with a valid, authorized user id and password.
Passwords can be set to expire - this forces password renewal.
| (e) Use of secure, computer-generated,
time-stamped audit trails to independently record the date and time
of operator entries and actions that create, modify, or delete electronic
records. |
Anytime a record is modified it is date and time stamped using the computer's
internal date and time. In addition the 254 character electronic signature
of the person making the change is attached to the record, along with
the person's printed name, and user id.
| Record changes shall not obscure
previously recorded information. |
When a record is changed in the database a corresponding entry is also
made in the Audit Log. This Audit Log entry records the "before"
and "after" entries of the training record and this Audit Log
entry is also date and time stamped, signed with the 254 character electronic
signature of the person making the change, the name of the person, and
the user id of the person.
| Such audit trail documentation
shall be retained for a period at least as long as that required for
the subject electronic records and shall be available for agency review
and copying. |
Training Tracker stores AUDIT records in a database. The database can
be quickly and easily backed up (unlike paper documents) providing "Protection
of records". Backups can be dated and retained on CD-Rom for long
periods of time.
| [[Page 121]]
(f) Use of operational system checks to enforce permitted sequencing
of steps and events, as appropriate. |
When a training record is changed the following steps occur: (1) First
the operator must click the "edit button" - this action records
the "before" value of the record (2) Next the operator changes
the training record (3) After the changes are made the operator's password
is requested. (4) A correct password must be entered (5) After the correct
password is entered the record is changed, the "after" vales
are recorded and the audit log is updated.
| (g) Use of authority checks
to ensure that only authorized individuals can use the system, electronically
sign a record, access the operation or computer system input or output
device, alter a record, or perform the operation at hand. |
Each user is assigned a "user level". The system can be set
so that only persons with a correct user level can do specific operations.
CAUTION - There is no control over the use of the use of input output
devices such as keyboard, disk drive or printer.
| (h) Use of device (e.g., terminal)
checks to determine, as appropriate, the validity of the source of
data input or operational instruction. |
Training Tracker can be run on a network. The network can allow only
specific terminals to access the data stored on a server.
| (i) Determination that persons
who develop, maintain, or use electronic record/electronic signature
systems have the education, training, and experience to perform their
assigned tasks. |
Only persons with assigned User IDs and Passwords can access Training
Tracker records.
(j) The establishment of, and
adherence to, written policies that hold individuals accountable and
responsible for actions initiated under their electronic signatures,
in order to deter record and signature falsification.
(k) Use of appropriate controls over systems documentation, including:
(1) Adequate controls over the distribution of, access to, and use
of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail
that documents time-sequenced development and modification of systems
documentation.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.100]
[Page 121]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart C--Electronic Signatures
Sec. 11.100 General requirements.
(a) Each electronic signature shall be unique to one individual
and shall not be reused by, or reassigned to, anyone else.
Each user is assigned a unique 254 character electronic signature
by Training Tracker. Training Tracker assigns this signature when
a record is changed and recorded in the audit log. "Before"
and "after" information is stored in the audit log along
with date and time stamp.
(b) Before an organization establishes, assigns, certifies, or
otherwise sanctions an individual's electronic signature, or any
element of such electronic signature, the organization shall verify
the identity of the individual.
(c) Persons using electronic signatures shall, prior to or at the
time of such use, certify to the agency that the electronic signatures
in their system, used on or after August 20, 1997, are intended
to be the legally binding equivalent of traditional handwritten
signatures.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of Regional
Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific electronic
signature is the legally binding equivalent of the signer's handwritten
signature.
[[Page 122]]
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.2]
[Page 119-120]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart A--General Provisions
Sec. 11.2 Implementation.
(a) For records required to be maintained but not submitted to
the agency, persons may use electronic records in lieu of paper
records or electronic signatures in lieu of traditional signatures,
in whole or in part, provided that the requirements of this part
are met.
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu
of traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S-0251 as being the type of submission
the agency accepts in electronic form. This docket will identify
specifically what types of documents or parts of documents are acceptable
for submission in electronic form without paper records and the
agency receiving unit(s) (e.g., specific center, office, division,
branch) to which such submissions may be made. Documents to agency
receiving unit(s) not specified in the public docket will not be
considered as official if they are submitted in electronic form;
paper forms of such documents will be
[[Page 120]]
considered as official and must accompany any electronic records.
Persons are expected to consult with the intended agency receiving
unit for details on how (e.g., method of transmission, media, file
formats, and technical protocols) and whether to proceed with the
electronic submission.
AIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.200]
[Page 122]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart C--Electronic Signatures
Sec. 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such
as an identification code and password. |
Each user is assigned a user id and an associated password
| (i) When an individual executes
a series of signings during a single, continuous period of controlled
system access, the first signing shall be executed using all electronic
signature components; subsequent signings shall be executed using
at least one electronic signature component that is only executable
by, and designed to be used only by the individual. |
In order for the individual to log in to the software both the user id
and password are required. Also, during login the expiration date is checked
to be sure it has not expired.
| (ii) When an individual executes
one or more signings not performed during a single, continuous period
of controlled system access, each signing shall be executed using
all of the electronic signature components. |
The only way that Training Tracker allows access to records is during
a single period of controlled access. The operator logs in, makes changes
and then quits the program. During each "signing" the operator's
password is requested each time.
| (2) Be used only by their genuine
owners; and |
During each "signing" the operator's password is requested
each time. This assures that if the operator logs in but walks away from
the terminal for a brief period without quitting the program, an unauthorized
operator cannot make a change.
| (3) Be administered and executed
to ensure that attempted use of an individual's electronic signature
by anyone other than its genuine owner requires collaboration of two
or more individuals. |
CAUTION - One person - the system administrator - can log on as any other
user and make changes that will appear to be made by that user. Other
than that only the logged on operator can make changes to a training record
because a password is required for each "signing".
| (b) Electronic signatures based
upon biometrics shall be designed to ensure that they cannot be used
by anyone other than their genuine owners.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.3]
[Page 120]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart A--General Provisions
Sec. 11.3 Definitions.
(a) The definitions and interpretations of terms contained in
section 201 of the act apply to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-
903 (21 U.S.C. 321-393)).
(2) Agency means the Food and Drug Administration.
(3) Biometrics means a method of verifying an individual's identity
based on measurement of the individual's physical feature(s) or
repeatable action(s) where those features and/or actions are both
unique to that individual and measurable. |
TT5.0 does NOT use biometrics
| (4) Closed system means an environment
in which system access is controlled by persons who are responsible
for the content of electronic records that are on the system. TT5.0
does NOT use biometrics
(5) Digital signature means an electronic signature based upon
cryptographic methods of originator authentication, 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. TT5.0
assigns a random 254 character signature when a new user is added.
The signature is tested against every other signature in the system
to assure that it is unique. The signature is not computed by a
set of rules but generated randomly. Once assigned when a new user
is added to the system, the 254 character signature is not changed.
(6) 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.
(7) Electronic signature means a computer data compilation of
any symbol or series of symbols executed, adopted, or uthorized
by an individual to be the legally binding equivalent of the individual's
handwritten signature.
(8) Handwritten signature means the scripted name or legal mark
of an individual handwritten by that individual and xecuted or adopted
with the present intention to authenticate a 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.
(9) Open system means an environment in which system access is
not controlled by persons who are responsible for the content of
electronic records that are on the system. TT5.0 depends on "raw"
access to the data files being controlled by the system administrator
setting "permissions" for access to files on the network.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.30]
[Page 121]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart B--Electronic Records
Sec. 11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or transmit
electronic records shall employ procedures and controls designed
to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation
to the point of their receipt. Such procedures and controls shall
include those identified in Sec. 11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital
signature standards to ensure, as necessary under the circumstances,
record authenticity, integrity, and confidentiality. |
TT5.0 depends on "raw" access to the data files being controlled
by the system administrator setting "permissions" for access
to files. This means that TT5.0 should not be used on an open system.
WAIS Document Retrieval[Code
of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.300]
[Page 122]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart C--Electronic Signatures
Sec. 11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of identification
codes in combination with passwords shall employ controls to ensure
their security and integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code
and password, such that no two individuals have the same combination
of identification code and password. TT5.0 does this. No two persons
can be assigned the same combination of user id and password.
(b) Ensuring that identification code and password issuances are
periodically checked, recalled, or revised (e.g., to cover such
events as password aging). TT5.0 allows expiration dates to be set
on passwords to allow or force periodic recall.
(c) Following loss management procedures to electronically deauthorize
lost, stolen, missing, or otherwise potentially compromised tokens,
cards, and other devices that bear or generate identification code
or password information, and to issue temporary or permanent replacements
using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use
of passwords and/or identification codes, and to detect and report
in an immediate and urgent manner any attempts at their unauthorized
use to the system security unit, and, as appropriate, to organizational
management.
(e) Initial and periodic testing of devices, such as tokens or
cards, that bear or generate identification code or password information
to ensure that they function properly and have not been altered
in an unauthorized manner.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.50]
[Page 121]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart B--Electronic Records
Sec. 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated
with the signing that clearly indicates all of the following:
(1) The printed name of the signer; TT5.0 adds the printed name
of the signer to each modified record and to the audit log.
(2) The date and time when the signature was executed; and TT5.0
adds a date and time stamp to each modified record and the audit
log.
(3) The meaning (such as review, approval, responsibility, or
authorship) associated with the signature. CAUTION - TT5.0 only
tracks changes. In other words if a change is made it is considered
to be reviewed and approved all at the same time. Approval is implied
by the person logging on having the authority to log on in the first
place.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3)
of this section shall be subject to the same controls as for electronic
records and shall be included as part of any human readable form
of the electronic record (such as electronic display or printout).
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.70]
[Page 121]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart B--Electronic Records
Sec. 11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to electronic
records shall be linked to their respective electronic records to
ensure that the signatures cannot be excised, copied, or otherwise
transferred to falsify an electronic record by ordinary means. |
|
