Some areas of the laboratory (especially blood banking) may be required to meet 21 CFR Part 11 requirements regarding electronic signatures. Document Control from MediaLab can help your laboratory address 21 CFR Part 11 requirements.
Download a whitepaper on 21 CFR Part 11 + MediaLab Document Control
Subpart A General Provisions
This part lays out general definitions and terminology covered in 21 CFR Part 11, as well as the FDA’s powers and responsibilities in this area. No specific requirements applicable to Document Control are introduced here.
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:
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21 CFR
Part 11 Regulation
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MediaLab’s
Capability
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Subscriber’s
Steps to Address
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(a) Validation of systems
to ensure accuracy, reliability, consistent intended performance, and the
ability to discern invalid or altered records.
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Provides step-by-step validation plan to subscribers.
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Follow steps in validation plan and document their completion.
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(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.
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Displays documents in a human readable form on-screen. Provides
documents in electronic form for download to authorized users. Allows
authorized users to print controlled and uncontrolled paper copies.
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Automatic
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(c) Protection of records
to enable their accurate and ready retrieval throughout the records retention
period.
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Records are stored on redundant secure servers, backed up daily, and
backups are provided to subscribers for download
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Download backup file on a regular basis.
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(d) Limiting system
access to authorized individuals.
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Restricts access to users with established usernames and passwords
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Ensure that access to given only to appropriate individuals.
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(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 at
least as long as that required for the subject electronic records and shall
be available for agency review and copying.
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Automatically records all actions taken by users and by the system.
Actions are recorded in a permanent audit trail. Each action is time-stamped
and cannot be altered or removed. Full audit trail is available to authorized
users at any time.
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Automatic
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(f) Use of operational
system checks to enforce permitted sequencing of steps and events, as
appropriate.
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Requires documents to pass through appropriate stages (editing,
review, approval) before being made available to employees. Routes documents
through applicable approval processes.
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Automatic
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(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.
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Restricts access to documents and functions based on permissions
granted to a user. User must be identified by username and password upon
login; must identify with PIN prior to any signature.
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Establish appropriate permissions within the system. Add or remove
permissions as personnel and responsibilities change.
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(h) Use of device (e.g.,
terminal) checks to determine, as appropriate, the validity of the source of
data input or operational instruction.
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Requires username and password to authorize entry. Logs out users
after set period of inactivity.
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Complete validation plan. Ensure that users’ computers are free from
malware.
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(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.
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Provides CVs for key MediaLab personnel upon request. Provides user’s
guide, “Get started” wizard, training documents, and system help to guide
users.
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Evaluate employees’ education, training, and experience.
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(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.
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n/a
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Develop policies and procedures that reflect user responsibilities
and requirements. Store these documents within Document Control.
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(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.
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Provides updated user’s guide and release notes for system updates.
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Review documentation and release notes for updates.
Repeat validation after system updates to ensure proper operation.
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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 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.
MediaLab Document Control is considered a closed system. This section is not applicable.
Sec. 11.50 Signature manifestations.
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21 CFR
Part 11 Regulation
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MediaLab’s
Capability
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Steps to
Address
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(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;
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Included
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Automatic
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(2) The date and time
when the signature was executed; and
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Included
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Automatic
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(3) The meaning (such as
review, approval, responsibility, or authorship) associated with the
signature.
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Included
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Automatic
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(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).
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Included
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Automatic
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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.
Signatures executed in MediaLab are permanently linked to the document and version that has been signed. The signatures cannot be edited, duplicated, or removed in any way.
Subpart C Electronic Signatures
Sec. 11.100 General requirements.
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21 CFR
Part 11 Regulation
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MediaLab’s
Capability
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Steps to
Address
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(a) Each electronic
signature shall be unique to one individual and shall not be reused by, or
reassigned to, anyone else.
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Ensures uniqueness of signatures by irrevocably linking them to
unique usernames, passwords, and PINs
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Automatic
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(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.
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n/a
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Verify employee identity before distributing system credentials
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(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.
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n/a
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Develop organizational policy / procedure and collect certifications
as needed.
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(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.
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n/a
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Mail certification in paper form to specified address.
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(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.
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n/a
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Develop organizational policy / procedure and collect certifications
as needed.
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Sec. 11.200 Electronic signature components and controls.
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21 CFR
Part 11 Regulation
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MediaLab’s
Capability
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Steps to
Address
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(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.
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Requires three distinct components: username, password, and PIN.
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Require each signer to create PIN (under “Home” tab).
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(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.
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Requires user to identify himself with username and password upon
logging in to the system and after period of inactivity.
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Automatic
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(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.
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Requires user to identify himself using PIN number before executing
each signature.
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Automatic
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(2) Be used only by their
genuine owners; and
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Enforces uniqueness of username and ensures identity of genuine user
by verifying password and PIN
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Automatic
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(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.
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Does not permit an electronic signature to be used by anyone other
than the genuine owner under any circumstance.
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Automatic
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(b) Electronic signatures
based upon biometrics shall be designed to ensure that they cannot be used by
anyone other than their genuine owners.
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Does not use electronic signatures based on biometrics
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n/a
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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:
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21 CFR
Part 11 Regulation
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MediaLab’s
Capability
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Steps to
Address
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(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.
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Ensures that usernames are unique to individuals and
cannot be repeated. No two individuals can have duplicated identification
codes.
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Automatic
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(b) Ensuring that identification code and
password issuances are periodically checked, recalled, or revised (e.g., to
cover such events as password aging).
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Provides mechanism for periodic password expiration.
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Establish time period for password expiration (under “Users”
tab).
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(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.
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Provide mechanism to partially to completely revoke access
for individual users.
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Partially or completely revoke access for users when
necessary.
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(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.
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Reports failed login attempts to genuine account holder, administrative
users in the subscription, and MediaLab system support staff.
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Automatic
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(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.
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Does not use these devices.
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n/a
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Download a whitepaper on 21 CFR Part 11 + MediaLab Document Control
