Electronic Records and Digital Signature Seminar

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Electronic records and Digital signature NBA(UG)
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A Seminar presented as a part of I year

M.Pharm II Semester requirement
ACY 2019 – 2020
By
S.Chandana priya
Regd.No: 19L81S402
Department of Pharmaceutical Quality Assurance

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Welcome SIRO -
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to the
World of Digital Technology

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“No product is made today, no person moves
today, nothing is collected, analyzed or
communicated without some digital
technology’ being an integral part of it. That,
in itself, speaks the overwhelming ‘value’ of
digital technology”
- Louis Rossetto

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Introduction OUS
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• All organizations involved in drug and device DSIR
distribution, approval, manufacturing and quality

assurance are aware of the Food and Drug
Administration's 21 CFR Part 11 (or more familiarly,
Part 11), but individuals within these organizations
frequently have trouble understanding its application.

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21 CFR Part 11 OUS
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• It is the part of Title 21 of the Code of Federal NBA(UG)
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Regulations that establishes the United States Food andDSIR
Drug Administration (FDA) regulations on Electronic
Records and Electronic Signatures (ERES).
• Part 11, as it is commonly called, defines the criteria
under which electronic records and electronic signatures
are considered trustworthy, reliable, and equivalent to
paper records .

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It is defined as any combination of text, graphics, NAAC &
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data, audio, pictorial or other information re – SIRO -
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presentation in digital form that is created, modified,

maintained, archived, retrieved or distributed by a computer
system, and is applicable to records required by any other
FDA regulation and applicable to records submitted to FDA
under the Food, Drug &Cosmetic Act or the Public Health
Service Act, even if not required by FDA.

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Documents management NAAC &
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Examples of Electronic records include: SIRO -
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• emails, websites, Ms-Office documents, digital
purchase receipts, databases, text messages, social
media postings, and information stored on
SharePoint sites and content management systems
(Catalyst, Slack, DropBox, etc.)

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• It also applies to electronic records submitted to the
agency under the requirements of the Federal Food,
Drug, and Cosmetic (FD&C) Act and the Pubic
Health Service Act, even if such records are not
specifically identified in agency regulations.

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• In addition to meeting the regulation's criteria, SIRO -
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official FDA submissions that consist of electronic
records are acceptable only if the type of record being
submitted has been identified in a public docket (No.
92S-0251) as one that FDA is ready to accept in
electronic form (62 FR:13465).

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• If the type of record has not been identified in the SIRO -
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public docket, official submissions must be on paper.
• For records that are maintained but not necessarily

submitted to FDA, electronic records can substitute for
paper records as long as they meet the criteria set forth in
the rule (62 FR:13435).

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• Individuals are also expected to consult the NAAC &
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appropriate FDA division before proceeding DSIR
with submission of records in electronic form (21

CFR 11.2(b)).
• Furthermore, the regulation stipulates that computer
systems (including hardware and software), controls,
and attendant documentation maintained under the
rule are subject to FDA inspection (21 CFR 11.1(e)).

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Specifically, FDA's concerns focused on the relative NBA(UG)
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ease with which electronic signatures and data sets can be
falsified or altered.
• For example, FDA expressed concern that: Database
elements can be changed at any time to misrepresent
information without evidence that a change was made
and in a manner that destroys the original.

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• More staff may have access to electronic records NBA(UG)
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than to paper records and can be falsified more
readily than traditional handwritten signatures.
• An electronic signature based on a combination with
an identification code can be loaned or lost.
• Falsification is easier to achieve and cannot be
detected (62 FR:13432—13433).

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Limiting FDA’s access to records NAAC &
proves challenging NBA(UG)
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• FDA's inspection authority includes the power to

inspect records that are kept in an electronic format;
• However, FDA does not have the right to inspect all
company records.

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• Providing access to electronic records will make it NBA(UG)
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more difficult to ensure that only required records
are turned over to FDA, as the scope of a request

based on the volume of paper.
• As a result, it may prove much easier to
inadvertently provide FDA with documents the
agency is not entitled to inspect.

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Requirements of 21 CFR part 11 OUS
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• All computerized systems must be validated. SIRO -
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• There needs to be secure retention of electronic records

and instant retrieval.
• User-independent computer-generated time-stamped audit
trails.
• System and data security, data integrity and confidentiality
through limited authorized access to systems and records.

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• Use of secure electronic signatures for closed NBA(UG)
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and open systems. DSIR
• Use of digital signatures for open systems.
• Use of operational checks.

• Use of device checks.
• Educated persons for maintenance or use electronic
systems to perform their assigned task.

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Why computer systems are needed to be compliant to OUS
21CFR part 11 ? NAAC &
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• All computer systems which store data which is used
to make Quality decisions/data which will be reported
to the FDA must be compliant with 21 CFR 11.
• In laboratory situations, this includes any laboratory
results used to determine quality, safety, strength,
efficacy, or purity.

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• In clinical environments, this includes all data SIRO -
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to be reported as part of the clinical trial used to

determine quality, safety, or efficacy.
• In manufacturing environments, this includes all
decisions related to product release and product
quality.

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What is accurate record generation? NAAC &
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• It means that records entered into the system must be
completely retrievable without unexpected alteration
or unrecorded changes.
• This is generally tested by verifying that records
entered into the system must be accurately displayed
and accurately exported from the system.

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How records must be protected? NAAC &
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• Electronic records must not be corrupted and must be

readily accessible throughout the record retention
period.
• This is usually performed through a combination of
technological and procedural controls.

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Example for document is OUS
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created/encrypted NBA(UG)
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Why documentations are required for OUS
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21 CFR part 11 compliant programs? NBA(UG)
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 Documentation must exist which defines system

operations and maintenance.
 Typically these requirements are met by company
document control procedures.

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Requirements for Electronic records OUS

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• Include the printed name of the signer, the date/time
the signature was applied, and the meaning of the
electronic signature.
• Be included in human readable form of the record.
Electronic signatures must not be separable from their
record.

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• Must be unique to a single user and not used by SIRO -
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anyone else.
• Can use biometrics to uniquely identify the user. If
biometrics are not used, they need at least two distinct
identifiers (for example, the user ID and a secret
password).

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Advantages of Electronic Records OUS
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 Faster data transfer DSIR
 Instant data access

 Reduced queries
 Data can be categorized
 Ease in decision-making
 Savage of time and money

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Disadvantages of Electronic records NAAC &
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• Cost-effective in implementation
• Availability of internet connection

• Data security
• Regular validation of electronic devices
• Regulatory compliance

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Main reasons for choosing electronic AUTONOM
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records are: NAAC &
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 Fast and Easy retrieval (Easy access) DSIR
 Version control (previous versions are not valid)

 Security (encryption services)
 Legal compliance (provides information quickly and

efficiently)
 Disaster recovery (Cloud based backup and storage
systems)
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Electronic record provisions AUTONOM

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 Closed system - an environment in which system access is NBA(UG)
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controlled by persons who are responsible for the content of
electronic records that are on the system
 Open system - 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
 Hybrid system - a system for which handwritten signatures executed
on paper and paper-based records are maintained in addition to
electronic records

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Access criteria OUS
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• Policies stipulating who has access records DSIR
and on restricted records,

• Assurance that access and retrieval are timely,
• Assurance that records are retrievable by authorized
users only,
• Relevant metadata applicable to the captured record,
and
• Recognition on privacy issues.

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E-records infrastructure should consists OUS
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• wide awareness of the value of records; SIRO -
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• effective laws and policies;

• governance and accountability arrangements;
• consistent and effective standards and practices;
• influence and guide change;

• cost-effective computer-based systems; and
• adequate budget, space, and supplies.

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Control on records OUS
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• Measures to monitor who has access to records, DSIR
• Safeguard the records from unauthorized access to ensure

integrity of the records is maintained at all times,
• Audit trail of all records to capture all activity to ensure the
records are not compromised,
• Demonstration that migration, system malfunctions,
upgrades,

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• Regular maintenance of records systems will not SIRO -
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infringe upon the integrity of the records,
• Methodologies to protect the confidentiality, privacy,
and security of records from unauthorized access,
tampering, or disposal,
• Validation/verification techniques that ensure system
and functional compliance requirements are met,

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• Records protection and preservation requirements NBA(UG)
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also must be met,
• Ability of the records system to preserve records and
their associated metadata and be accessible throughout its
retention period, and
• Ability for long-term or archival storage, and ensure
these records and data remain accessible in the future.

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Digital Signatures

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What is a Digital signature? OUS
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• A digital signature is a mathematical technique DSIR
used to validate the authenticity and integrity of a
message, software or digital document.

• it can offer far more inherent security, and is intended to
solve the problem of tampering and impersonation in
digital communications.

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• The FDA considers any organization that uses NAAC &
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electronic signatures to be an entity with an DSIR
electronic record system that must comply with the code in

its entirety and the systems of the aforementioned
organizations because they directly affect public safety.
• Part 11 relates data integrity to the reliability of the
electronic records created and managed by an
organization's critical operating systems.

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Classes of Digital signature based on OUS
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type of certificate NBA(UG)
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• Class 1 DSIR
• Class 1 signatures provide a basic level of security

and are used in environments with a low risk of data
compromise.
• It can’t be used for legal business documents as they
are validated based only on an email ID and
username.
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• Class 2 NAAC &
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• These used for e-filing of tax documents, including DSIR
income tax returns and Goods and Services Tax
(GST) returns.
• This type authenticates a signee’s identity against a
pre-verified database.
• These are used in environments where the risks and
consequences of data compromise are moderate.

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• Class 3 NAAC &
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• The highest level of digital signatures. SIRO -
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• This require a person or organization to present in front

of a certifying authority to prove their identity before
signing.
• These are used for e-auctions, e-tendering, e-ticketing,
court filings and in other environments where threats to
data or the consequences of a security failure are high.

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When are electrical signatures needed? NAAC &
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• There is (as yet) no obligation to create and deliver

documents in a digital format. However, there is
increasing pressure from the authorities and notified
bodies to do this.

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• Standardized electronic formats like CDISC NAAC &
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(Clinical Data Interchange Standards Consortium) InDSIR
the case of clinical trials are to some extent the single

most efficient form of communication.
• As soon as manufacturers create electronic
documents instead of paper documents, must replace
handwritten signatures with electronic or digital
signatures.

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Subpart A – General provisions OUS
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• Part 11 consists of three subparts. Subpart A DSIR
contains the general provisions and describes the code's

scope, implementation and definitions.
• Section 11.2 says that companies can maintain
documents in electronic form and use electronic
signatures in place of traditional signatures.
• Section 11.3 simply defines the terms used in Part 11.

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Subpart B – Electronic Records OUS

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• Subpart B focuses on electronic records and discusses
the applicable controls for closed and open systems
(sections 11.10 and 11.30, respectively), signature
manifestations (11.50) and processes for linking
signatures to documents (11.70).

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• The integrity of system operations and information NBA(UG)
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stored in a given system are protected by certain
measures for closed systems including:
 Validation
 The ability to generate accurate and complete copies of

the records
 Archival protection of the records

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 Use of computer-generated, time-stamped audit NAAC &
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trails DSIR
 Use of appropriate controls over systems

documentation
 Determine that persons who develop, maintain, or use
electronic records and signature systems have the
education, training and experience to perform their
assigned

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• Whether a system is closed or open depends on SIRO -
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the individuals who are responsible for the content of

the electronic records control access to the system
containing those records.
• If so, the system is closed; if not, it's open and requires
additional precautions.

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• These precautions include document encryption NBA(UG)
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and using appropriate digital signature standards to
ensure that entities maintain all records with
"authenticity, integrity and confidentiality."
• Open systems also require all the controls required
for closed systems.

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• Section 11.50 covers signature manifestations, NBA(UG)
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which must include: "the printed name of the signer, the
date and time when the signature was executed, and
the meaning associated with the signature.
• This states that signed electronic records shall contain
information and shall be included in any human-readable
form of the record.

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• Section 11.70 requires that a given system must OUS
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link a signature, whether electronic or handwritten, SIRO -
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to a particular electronic record in such a manner that
signatures are protected from excision, duplication or
transfer that could result in document falsification.
Note: The master record is still the electronic record, and
signing a printout of an electronic record doesn't exempt
the electronic record from Part 11 compliance.

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Subpart C – Electronic Signatures OUS
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• Section 11.100 says that electronic signatures are DSIR
legally binding and equivalent to handwritten

signatures.
• Only one individual verified by the issuing entity can
use a given electronic signature. Once assigned, an
organization must not reassign/reuse an electronic
signature other than the original assigned individual.

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• As with all best practices, enormous gains in SIRO -
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efficiency and productivity will ultimately result in
significant cost savings from implementation.
• Documentation and paper trail methodologies have
become so costly.
• Part 11 isn't just a cost of doing business; it's a trail of
forensic evidence testifying to the quality of products.

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Who issues Digital signatures? NAAC &
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• A licensed Certifying Authority(CA) issues the digital
signature. Certifying Authority means a person who
has been granted a license to issue a digital signature
certificate under section 24 of the IT-Act-2000.
• Controller, appointed by Central govt. of India is the
Head of Certifying Authorities.

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• A Digital signature Certificate is a secure digital NBA(UG)
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key that is issued by the certifying authorities for
the validating and certifying the identity of the person.
• A Digital signature certificate contains information
about the user’s name, pin code, country, mail address,
date of insurance of the certificate and name of
certifying authority.

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Difference between Electronic signature OUS
Vs Digital signature? NAAC &
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Electronic signature Digital signature DSIR
• An electronic signature is • A Digital signature is a

an electronic symbol guarantee that an electronic
attached to a contract or document is authentic.
other record, used by a
person with an intent to
sign.

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DocuSign’s advanced digital transaction OUS
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platform. NBA(UG)
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 Is used by many of the world’s largest enterprises
 Implements stringent standards for security and

compliance, including Public Key Infrastructure (PKI)
 Automates document flow
 Increases transaction speed

 Reduces operational costs

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Features of Digital signature

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• Authentication – They authenticate the source
of messages. Since digital certificate is bound to a
specific user, the signature shows that the user sent it.
• Integrity – Sometimes, the sender and receiver of a
message need an assurance that the message was not
altered during transmission.
• Non-Repudiation – A sender cannot deny sending a
message which has a digital signature.

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Digital signatures are time-bound OUS
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• They are eligible for a medium(long) or even DSIR
permanent retention period.

• This technique is designed for the short-term
validation of digital documents and are validated
immediately after the transfer.
• The authentication function of this is a short-life
cycle.

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• The validation of the document after a certain NAAC &
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time has elapsed since receipt, forms a problem DSIR
i.e., preservation period of records can’t exceed this

validity period of several years or less.
• Migration is at present the most widely applied
preservation strategy.
• The digital documents are migrated to a suitable
archiving format.

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Validation chain must be available OUS

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• To continue using digital signatures for the
authentication of digital documents in the future, as it is
not sufficient to preserve the records.
• For verification, an external PKI structure is required.
• The complete 'validation chain' including the digital

certificates and root certificates must remain available

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PKI(Public Key Infrastructure) OUS

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• It is the basis for digital signature today.
• Public Key Infrastructure (PKI) is a set of

requirements that allow (among other things) the
creation of digital signatures.
• It provides user with a pair of keys, private key and a
public key used in all signed transactions.

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PKI components….. OUS
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• A certificate authority(CA) DSIR
• A Registration authority(RA)
• A Central directory
• Validation authority(VA)
• A Certificate management system
• A Certificate policy

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• Certification authorities are usually commercial DSIR
organizations and distribute the digital certificates.

• For the verification of digital signatures, these
certificates must remain available.
• One has no guarantee that digital certificates will be
preserved in the long term.

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• The relatively short lifespan of software SIRO -
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applications for authentication, there is no evidence
that the technology will remain.
• The reconstruction of the necessary software in the
future on the basis of documented algorithms is indeed
possible, but that would be a fairly expensive and
complex issue.

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• The maintenance of such an external validation NAAC &
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structure also conflicts with the archival principle DSIR
as self-sufficient as possible.
• All essential elements of the 'validation chain' must be
present in the digital repository itself.
• A certificate archive would have to be set up and
secured very well, so certificates could not be changed
or added.

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An example for easy understanding NAAC &
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DSIR

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NAAC &
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Security
solutions

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Registration Validation AUTONOM

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• Immediately after receipt, the validity of the DSIR
digitally signed document is checked by means of the

digital signature.
• The result of this validation is registered by the receiver in
the metadata of the document.
• These metadata must be archived together with the record
and must be protected against any changes.

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• This approach is that the authentication SIRO -
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technology of a digital signature is predominantly
a technological solution and does not escape

technological obsolescence.
• Furthermore, the complete validation chain must be
archived.

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• An alternative is being sought in the embedding SIRO -
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measures for establishing the authenticity and
integrity in a procedure that is transferable.
• This approach also corresponds with the archival
view that documents used within a work process are
authentic though changes are made.

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Conclusion AUTONOM
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• The use of an advanced digital signature as a proof SIRO -
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of authenticity and integrity for electronic records raises
several questions and problems.
• They result in particular from the fact that the whole
concept of the digital signature is based on a digital object.
• In addition to the dependence on a 'validation chain', there
is also a huge dependence on technology.

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• Technology becomes obsolete quickly and there- SIRO -
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fore may not be the exclusive basis for assurance of
reliability.
• Therefore Technological solutions must be replaceable
and must be embedded in an overall management

procedure.

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• Furthermore, reliability includes more than NBA(UG)
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authenticity and integrity alone.
• Accuracy and trust also play an important role in the
archiving of reliable records.
• Assurance of reliability is a never ending process that
starts on creation or receipt, and must be maintained
during the entire life cycle.

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References……….

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• https://en.wikipedia.org/wiki/Title_21_CFR_Part_11 NAAC &
NBA(UG)
• https://www.qualityze.com/blogs/electronic-signatures-new-prot
SIRO -
ocol-verification-quality-records documents/#:~:text=Any%20d
DSIR
ocuments%20signed%20electronically%20need,sense%20of%2
0authorization%20as%20well
.
• http://www.presentationeze.com/blog/electronic-signatures-requ
irements-medical-device-manufacturing/
• https://www.qualitydigest.com/july05/articles/02_article.shtml
• https://www.contractpharma.com/issues/2002-11/view_features/
electronic-records-amp-electronic-signatures/
• https://www.mfiles.com/Content/documents/en/res/inthenews/Q
uality_Progress_article_May_2013_avoiding_avalanche.pdf

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• https://www.recordnations.com/articles/whats-best-paper-dig
NAAC &
ital-record management/#:~:text=Digital%20records%20giv NBA(UG)
e%20you%20the,and%20while%20it's%20being%20transmi SIRO -
tted DSIR
.
• https://www.mddionline.com/understanding-fdas-electronic-
records-and-signatures-regulation#:~:text=electronic%20rec
ords%20and%20signatures%E2%80%94a,records%20and%
20traditional%20handwritten%20signatures
.
• http://www.expertisecentrumdavid.be/docs/digitalsignatures.
pdf
• https://www.sciencedirect.com/topics/psychology/electronic-
record

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OUS
• https://www.toppr.com/guides/business-laws-cs/cyber-laws/d
NAAC &
igital-signature/ NBA(UG)
SIRO -
• https://www.fda.gov/regulatory-information/search-fda-guida
DSIR
nce-documents/part-11-electronic-records-electronic-signatur
es-scope-and-application
• https://www.cognidox.com/blog/what-is-fda-21-cfr-part-11
• https://www.slideshare.net/atuljaybhaye/digital-signatures-10
8792026
• https://www.icsi.edu/media/portals/86/Geeta_Saar_71_Maint
enance_and_inspection_of_documents_in_ele.pdf
• https://innovareacademics.in/journal/ajpcr/Vol6Suppl2/178
2.pdf

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Electronic Records and Digital Signature Seminar

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A Seminar presented as a part of I year

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

distribution, approval, manufacturing and quality

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

presentation in digital form that is created, modified,

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

public docket, official submissions must be on paper.

• For records that are maintained but not necessarily

Department of Pharmaceutical Quality Assurance

with submission of records in electronic form (21

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

• FDA's inspection authority includes the power to

Department of Pharmaceutical Quality Assurance

are turned over to FDA, as the scope of a request

Department of Pharmaceutical Quality Assurance

• There needs to be secure retention of electronic records

Department of Pharmaceutical Quality Assurance

• Use of digital signatures for open systems.

• Use of operational checks.

systems to perform their assigned task.

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

to be reported as part of the clinical trial used to

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

• Electronic records must not be corrupted and must be

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

 Documentation must exist which defines system

Department of Pharmaceutical Quality Assurance

Requirements for Electronic records OUS

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

 Instant data access

Department of Pharmaceutical Quality Assurance

• Availability of internet connection

Department of Pharmaceutical Quality Assurance

 Version control (previous versions are not valid)

 Legal compliance (provides information quickly and

Electronic record provisions AUTONOM

Department of Pharmaceutical Quality Assurance

and on restricted records,

Department of Pharmaceutical Quality Assurance

• effective laws and policies;

• influence and guide change;

• adequate budget, space, and supplies.

• Safeguard the records from unauthorized access to ensure

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

Department of Pharmaceutical Quality Assurance

used to validate the authenticity and integrity of a