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| 21 CFR Part 11 System Assessment |
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| Procedures and Controls for Closed Systems |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.10(a) |
Such procedures and controls shall include the following:
(a) Validation of system to ensure accuracy, reliability, consistent intended performance,
and the ability to discern invalid or altered records. |
Is the system validated? |
n.a. |
The software development life cycle of ARGUS/Dissolution follows the GAMP4 Guide.
Functionality of ARGUS/Dissolution complies with all requirements imposed by the regulatory authorities.
Together with its high standard of quality this makes validation of the system in the operating environment
of the customer very easy. |
| Is it possible to discern invalid or altered records? |
yes |
Electronic records created by the integrated electronic document management system of
ARGUS/Dissolution are cryptographically protected. |
| §11.10(b) |
(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. |
Is the system capable of producing accurate and complete copies of electronic records on paper? |
yes |
Printed copies of electronic records may be reproduced at any time. |
| Is the system capable of producing accurate and complete copies of records in electronic form for
inspection, review, and copying by the FDA? |
yes |
Copies of electronic records can be provided at any time in the standard electronic file formats XML and PDF. |
| §11.10(c) |
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. |
Are the records readily retrievable throughout their retention period? |
yes |
ARGUS/Dissolution gives the customer all the flexibility needed to keep and maintain electronic records according to
a predicate rule requirement. Records can be retrieved at any time
- in paper format
- electronically, by the integrated document management system
- electronically, as PDF or XML documents
|
| §11.10(d) |
(d) Limiting system access to authorized individuals. |
Is system access limited to authorized individuals? |
yes |
The user management system of ARGUS/Dissolution makes sure that only registered individuals have access to
the system and its functionality according to their level of authorization. |
| §11.10(e) |
(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.
Record changes shall not obscure previously recorded information.
Such audit trail documentation shall be retained for a period as least as long as that required for the subject
electronic records and shall be available for agency review and copying. |
Is there a secure, computer generated, time stamped audit trail that records the date and time of operator
entries and actions that create, modify, or delete electronic records? |
yes |
ARGUS/Dissolution ensures trustworthiness and reliability of electronic records through a highly detailed audit trail tightly linked to each record. |
| Upon making a change to an electronic record, is previously recorded information still
available (i.e., not obscured by the change)? |
yes |
ARGUS/Dissolution allows for a full traceability of the document life cycle.
The version numbering mechanism for electronic records prevents obscuring changes to electronic records by previous entries.
All changes are documented in the audit trail.
With each change the version number of the electronic record is increased. |
| Is an electronic record's audit trail retrievable throughout the record's retention period? |
yes |
ARGUS/Dissolution allows to retrieve an audit trail throughout the whole retention period imposed by a predicate rule. |
| Is the audit trail available for review and copying by the FDA? |
yes |
At any time, ARGUS/Dissolution is capable to make an audit trail available for agency review and copying. |
| §11.10(f) |
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. |
If the sequence of system steps or events is important, is this enforced by the system
(e.g., as would be the case in a process control system)? |
yes |
Argus/Dissolution enforces sequencing of steps by means of a several wizards,
e.g. for analysis, method creation and system configuration. |
| §11.10(g) |
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record,
access the operation or computer input or output device, alter a record, or perform the operation at hand. |
Does the system ensure that only authorized individuals can use the system, electronically sign records,
access the operation, or computer system input or output device, alter a record, or perform other operations? |
yes |
ARGUS/Dissolution allows for a highly sophisticated user authorization management including roles with different levels
of authorization. The user authorization management makes sure that only registered and authorized individuals have access
to the system and can make use of electronic signatures. |
| §11.10(h) |
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or
operational instruction. |
If it is a requirement of the system that input data or instructions can only come from certain input devices
(e.g., terminals) does the system check the validity of the source of any data or instructions received?
(Note: This applies where data or instructions can come from more than one device, and therefore the system must verify
the integrity of its source, such as a network of weigh scales, or remote, radio controlled terminals) |
yes |
ARGUS/Dissolution controls and identifies all hardware devices being part of the system. |
| §11.10(i) |
(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. |
Is there documented training, including on the job training for system users, developers, IT support staff? |
n.a. |
Customers responsibility |
| §11.10(j) |
(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. |
Is there a written policy that makes individuals fully accountable and responsible for actions initiated under their
electronic signatures? |
n.a. |
Customers responsibility |
| §11.10(k) |
Use of appropriate controls over systems documentation: |
Is the distribution of, access to, and use of systems operation and maintenance documentation controlled? |
n.a. |
Customers responsibility |
| Is there a formal change control procedure for system documentation that maintains a time sequenced audit trail for
those changes made by the pharmaceutical organization? |
n.a. |
Customers responsibility |
| Additional Procedures and Controls for Open Systems |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.30 |
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 their receipt. Such procedures and controls shall include those
identified in §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. |
Is data encrypted? |
No |
ARGUS/Dissolution is not intended for use as an open system. Therefore electronic records created by ARGUS/Dissolution
are not encrypted. |
| Are digital signatures used? |
yes |
Electronic signatures applied with ARGUS/Dissolution are based on a cryptographic method of originator authentication. |
| Signed Electronic Records |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.50 |
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the
following:
- The printed name of the signer
- The date and time when the signature was executed; and
- The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
(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 human readable form of the electronic record (such as electronic
display or printout).
|
Do signed electronic records contain the following related information?
- The printed name of the signer
- The date and time of signing
- The meaning of the signing (such as approval, review, responsibility)
|
yes |
|
| Is the above information shown on displayed and printed copies of the electronic record? |
yes |
|
| §11.70 |
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. |
Are signatures linked to their respective electronic records to ensure that they cannot be cut, copied, or otherwise transferred
by ordinary means for the purpose of falsification? |
Yes |
Using a Global Unique Identification Code (GUID) ARGUS/Dissolution makes sure that an Electronic Signature is inseparably
linked to its respective Electronic Record. |
| Electronic Signatures (General) |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.100(a) |
(a) Each electronic signature shall be unique to the one individual and shall not be reused by,
or reassigned to, anyone else. |
Are electronic signatures unique to an individual? |
yes |
Handling of electronic signatures as implemented in ARGUS/Dissolution guarantees that each signature is unique. |
| Are electronic signatures ever reused by, or reassigned to, anyone else? |
no |
Handling of electronic signatures in ARGUS/Dissolution guarantees that a signature can never be reused or reassigned. |
| §11.100(b) |
(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. |
Is the identity of an individual verified before an electronic signature is allocated? |
n.a. |
Customers responsibility. |
| Electronic Signatures (Non-biometric) |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.200(a)(1) |
(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. |
Is the signature made up of at least two components, such as an identification code and password,
or an id card and password? |
Yes |
Password construction in ARGUS/Dissolution implies using username and password. |
| §11.200(a)(1)(i) |
(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. |
When several signings are made during a continuous session, is the password executed at each singing?
(Note: both components must be executed at the first signing of a session). |
Yes |
During a continuous session ARGUS/Dissolution asks for the password at each signing. |
| §11.200(a)(1)(ii) |
(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. |
If signings are not done in a continuous session, are both components of the electronic signature executed with each signing? |
yes |
During a non-continuous session ARGUS/Dissolution asks for the username and password at each signing. |
| §11.200(a)(2) |
(2) Be used only by their genuine owners; and |
Are non-biometric signatures only used by their genuine owners? |
n.a. |
Customers responsibility. |
| §11.200(a)(3) |
(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. |
Would an attempt to falsify an electronic signature require the collaboration of at least two individuals? |
yes |
User data can only be altered by the system administrator. |
| Electronic Signatures (Biometric) |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.200(b) |
(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other
than their genuine owners. |
Has it been shown that biometric electronic signatures can be used only by their genuine owner? |
n.a. |
ARGUS/Dissolution does not support the use of biometric electronic signatures. |
| Controls for Identification Codes and Passwords |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.300(a) |
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. |
Are controls in place to maintain the uniqueness of each combined identification code and password,
such that no individual can have the same combination of identification code and password? |
yes |
|
| §11.300(b) |
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised
(e.g., to cover such events as password aging). |
Are procedures in place to ensure that the validity of identification codes is periodically checked? |
yes |
ARGUS/Dissolution checks the validity of the identification code during the login procedure. |
| Do passwords periodically expire and need to be revised? |
yes |
ARGUS/Dissolution allows for setting of a password expiration period. |
| Is there a procedure for recalling identification codes and passwords if a person leaves or transfers? |
yes |
ARGUS/Dissolution provides a user management system which allows to recall identification codes and
reassign passwords by the system administrator. |
| §11.300(c) |
(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 and password information,
and to issue temporary or permanent replacements using suitable rigorous controls. |
Is there a procedure for electronically disabling an identification code or password if it is potentially compromised or lost? |
yes |
ARGUS/Dissolution provides a user management system which allows to disable an identification code or a passwords by
the system administrator. |
| §11.300(d) |
(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. |
Is there a procedure for detecting attempts at unauthorized use and for informing security? |
yes |
ARGUS/Dissolution records any attempt of unauthorized use in the system log file. |
| Is there a procedure for reporting repeated or serious attempts at unauthorized use to management? |
n.a. |
Customers responsibility |
| Controls for Tokens, Cards and other Devices bearing or generating Identification Code or Password Information |
| Section |
Text in Part 11 |
Question |
Answer |
Comments |
| §11.300(c) |
(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 and
password information, and to issue temporary or permanent replacements using suitable rigorous controls. |
Is there a loss management procedure to be followed if a device is lost or stolen? |
n.a. |
No tokens, cards or similar in use |
| Is there a procedure for electronically disabling a device if it is lost, stolen, or potentially compromised? |
n.a. |
No tokens, cards or similar in use |
| Are there controls over the issuance of temporary and permanent replacements? |
n.a. |
No tokens, cards or similar in use |
| §11.300(e) |
(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. |
Is there initial and periodic testing of tokens and cards? |
n.a. |
No tokens, cards or similar in use |
| Does this testing check that there have been no unauthorized alterations? |
n.a. |
No tokens, cards or similar in use |
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