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Food Safety & Quality Management
Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe
Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe
Sep 25, 2024
Food Safety & Quality Management
Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe
Sep 25, 2024
Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe
Food Safety & Quality Management
Sep 25, 2024
If you are an FDA-regulated industry, you must be familiar with one of the FDA’s key premises for operations; if you didn’t document it, you didn’t do it. This notion exemplifies the significance of maintaining compliant documentation based on the established FDA predicate rules.
A vital requirement in this context is the 21 CFR Part 11 regulation. It is a section of the Code of Federal Regulations (CFR) issued by the FDA outlining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
What is Meant By 21 CFR Part 11?
Breaking down the meaning of “21 CFR Part 11” involves:
- 21 refers to “Title 21,” which is the section of the Code of Federal Regulations (CFR) dedicated to regulations for food and drugs. The CFR itself is divided into 50 different titles.
- CFR stands for “Code of Federal Regulations,” a collection of laws organized by numbers and letters, published by the U.S. federal government.
- Part 11 focuses specifically on the regulations surrounding electronic records and electronic signatures, including those submitted electronically to the FDA.
Interpreting 21 CFR Part 11 Regulations
Specifically, 21 CFR Part 11 means: Title 21 > Chapter 1 > Subchapter A > Part 11. The 21 CFR Part 11 regulation is divided into three subparts:
SUBPART A – GENERAL PROVISIONS
11.1 – Scope
11.2 – Implementation
11.3 – Definitions
SUBPART B – ELECTRONIC RECORDS
11.10 – Controls for closed systems
11.30 – Controls for open systems
11.50 – Signature manifestations
11.70 – Signature/record linking
SUBPART C – ELECTRONIC SIGNATURES
11.100 – General requirements
11.200 – Electronic signature components and controls
11.300 – Controls for identification codes/passwords
Here’s a summarized interpretation encompassing the key takeaways from 21 CFR Part 11 Subparts and Sections:
Food Safety Management Software
Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.
Food Safety Management Software
Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.
SUBPART A – GENERAL PROVISIONS
-
Part 11 applies to all electronic records governed by FDA regulations.
-
If an organization proves to an auditor that its electronic records and signatures are as reliable as paper records and handwritten signatures, the FDA will accept electronic versions.
-
The FDA will accept electronic submissions instead of paper if:
- They comply with Part 11 requirements.
- They are among the document types the FDA allows for electronic submission.
SUBPART B – ELECTRONIC RECORDS
-
Organizations utilizing electronic records must establish and document procedures and controls to ensure the following attributes in their records:
- Authenticity
- Integrity
- Confidentiality (when applicable)
- Irrefutability (i.e., the record cannot be disputed as genuine) -
Documented procedures and controls must cover:
a. Computer Systems Validation (CSV)
b. Record Rendering
c. Document Storage and Retention
d. System Access
e. Audit Trails
f. Workflows
g. Authority Checks
h. Device Checks
i. Personnel Qualifications
j. Personnel Accountability
k. Document Control -
Additionally, systems categorized as “Open” (as defined in Subpart A) require further procedures and controls. Electronic signatures must include:
- The printed name of the signer
- The date and time of the signature
- The meaning of the signature -
Electronic signatures must remain permanently linked to their corresponding records.
SUBPART C – ELECTRONIC SIGNATURES
-
Organizations planning to implement electronic signatures must notify the FDA in writing before transitioning.
-
Each person using an electronic signature must 1) have their identity verified and 2) use a unique signature that is exclusive to them and will not be used by anyone else.
-
There are distinct design requirements for electronic signatures, whether they are biometric (e.g., fingerprint scans) or non-biometric (e.g., user IDs and passwords).
-
For electronic signatures based on user IDs and passwords or passcodes, there are specific requirements for the passwords and the devices used to generate passcodes.
How Smart Food Safe Can Be Your Tech-Enabler in Complying With 21 CFR Part 11
When it comes to ensuring your business’ regulatory requirements with regard to electronic systems meet 21 CFR Part 11 standards, it can seem overwhelming. But no worries, Smart Food Safe solutions demonstrate how to make compliance easy and effortless. This platform provides a streamlined, purpose-built solution designed to tackle common compliance issues, ensuring your electronic food safety systems are up to standard with the latest regulations and best practices.
Compliance Issues Faced
Smart Food Safe’s Solutions
SUBPART B – ELECTRONIC RECORDS
11.10 Controls for Closed Systems
-
Unauthorized Record Deletion/Tampering: Risk of records being deleted or altered without proper oversight.
-
Accurate and Complete Records: Records are exportable in PDF and Excel formats, maintaining data integrity for regulatory reviews.
-
Record Protection: Records cannot be deleted but only archived, ensuring they are accessible at any time while preserving their integrity.
-
Lack of Traceability: Difficulty in tracking changes or actions related to records.
-
Audit Trails: All record activities are logged in real-time, capturing user details and timestamps, ensuring accountability and compliance.
-
Inadequate User Access Controls: Unrestricted access leads to potential unauthorized actions or data breaches.
-
Limited Access: Only authorized users can access the platform, secured by unique credentials, with optional two-factor authentication and Single Sign-On.
-
Authority Checks: Access is role-based, with different permissions for operators and managers, and workflows control access to specific actions.
-
Controlled Accessibility: Access is limited based on user roles and workflows, ensuring proper access management and audit trail generation.
-
Insufficient Training on Usage: Users may not manage records correctly due to a lack of adequate training.
-
Training: Onboarding includes customized training and the Smart Training module, ensuring users can effectively manage electronic records.
-
Weak Accountability: Challenges in ensuring the integrity and authenticity of user actions on records.
-
Accountability: Role-based responsibilities and secure, unfalsifiable electronic signatures ensure traceability and integrity.
11.30 Controls for Open Systems
-
Data Leakage or Interception: Potential for data compromise or leakage.
-
Tenant Isolation: Segregation of tenants within the shared infrastructure to prevent data compromise.
-
Role Misalignment: Issues arising from allowing inappropriate access to critical environments.
-
Segregation of Duties: Restricted access to production environments based on job roles.
-
Downtime, Data Loss & Performance Concerns: Potential system downtime or decreased performance or availability of services risking data loss.
-
Serverless Architecture: High availability, seamless deployment, and monitoring across multiple zones.
-
Data Backup: Automated backups with fast recovery times, ensuring RTO and RPO compliance.
-
Security Compliance: Follows AWS security standards like SOC 2, and ISO 27001.
-
Technical Weaknesses: Unaddressed vulnerabilities leading to possible exposure to security threats
-
Vulnerability Management: Continuous network scans and vulnerability assessments along with regular security testing.
-
Product Roadmap & QA: Security fixes are reviewed periodically, and rigorous testing ensures stable and secure software updates.
11.50 Signature Manifestations
-
Integrity of Electronic Signatures: Informal sign-offs often lack essential details, resulting in confusion or compliance failures as there is no reliable verification of who approved what and when.
-
Digital Sign-offs: Digital sign-offs in Smart Food Safe include the meaning of the signature, the signer’s name, and the date/time. These elements are strictly controlled and appear in all forms of the record, whether electronic or printed.
-
Layered Security Measures: Security layers ensure the authenticity and security of electronic signatures.
11.70 Signature/Record Linking
-
Lack of Traceability Associated With Electronic Signatures: Inadequate controls over electronic signatures can result in unauthorized changes, tampering, or forgery of signatures on critical records.
-
Linkage of Electronic Signatures to Records: Electronic signatures are automatically linked to their records and cannot be removed, copied, or altered. Signatures are generated when users take action on records and are protected from modification.
-
Audit Logs: Audit logs capture these signatures and are safeguarded against deletion or tampering.
-
Secure User Signatures: Users sign records using unique credentials, ensuring that signatures cannot be forged or misused.
SUBPART C – ELECTRONIC SIGNATURES
11.200 Electronic Signature Components and Controls
-
Insecure Authentication Methods: Weak authentication practices can result in unauthorized access and data breaches, impacting the authenticity and integrity of electronic documents.
-
Unique Username & Password: Identity is verified through a unique username and password for actions like creating or modifying documents.
-
Strong Authentication Mechanisms: Additional security options include two-step authentication, strengthened password policies, and single sign-on.
11.300 Controls for Identification Codes/Passwords
-
Inefficient Authentication: Single-factor authentication is susceptible to security breaches.
-
Customizable Password Policies: Customizable password policies allow for flexibility, including password reset options.
-
Two-Step Authentication: Two-step authentication is available for added security, requiring a verification code sent to a registered email.
-
Poor Visibility of User Activities: Lack of visibility into user activities can delay the detection of suspicious behavior or security threats.
-
Real-Time Activity Monitoring: Real-time activity logs track login details, browser info, IP addresses, and more to detect anomalies.
If you are an FDA-regulated industry, you must be familiar with one of the FDA’s key premises for operations; if you didn’t document it, you didn’t do it. This notion exemplifies the significance of maintaining compliant documentation based on the established FDA predicate rules.
A vital requirement in this context is the 21 CFR Part 11 regulation. It is a section of the Code of Federal Regulations (CFR) issued by the FDA outlining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
What is Meant By 21 CFR Part 11?
Breaking down the meaning of “21 CFR Part 11” involves:
- 21 refers to “Title 21,” which is the section of the Code of Federal Regulations (CFR) dedicated to regulations for food and drugs. The CFR itself is divided into 50 different titles.
- CFR stands for “Code of Federal Regulations,” a collection of laws organized by numbers and letters, published by the U.S. federal government.
- Part 11 focuses specifically on the regulations surrounding electronic records and electronic signatures, including those submitted electronically to the FDA.
Interpreting 21 CFR Part 11 Regulations
Specifically, 21 CFR Part 11 means: Title 21 > Chapter 1 > Subchapter A > Part 11. The 21 CFR Part 11 regulation is divided into three subparts:
SUBPART A – GENERAL PROVISIONS
11.1 – Scope
11.2 – Implementation
11.3 – Definitions
SUBPART B – ELECTRONIC RECORDS
11.10 – Controls for closed systems
11.30 – Controls for open systems
11.50 – Signature manifestations
11.70 – Signature/record linking
SUBPART C – ELECTRONIC SIGNATURES
11.100 – General requirements
11.200 – Electronic signature components and controls
11.300 – Controls for identification codes/passwords
Here’s a summarized interpretation encompassing the key takeaways from 21 CFR Part 11 Subparts and Sections:
Food Safety Management Software
Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.
SUBPART A – GENERAL PROVISIONS
-
Part 11 applies to all electronic records governed by FDA regulations.
-
If an organization proves to an auditor that its electronic records and signatures are as reliable as paper records and handwritten signatures, the FDA will accept electronic versions.
-
The FDA will accept electronic submissions instead of paper if:
- They comply with Part 11 requirements.
- They are among the document types the FDA allows for electronic submission.
SUBPART B – ELECTRONIC RECORDS
-
Organizations utilizing electronic records must establish and document procedures and controls to ensure the following attributes in their records:
- Authenticity
- Integrity
- Confidentiality (when applicable)
- Irrefutability (i.e., the record cannot be disputed as genuine) -
Documented procedures and controls must cover:
a. Computer Systems Validation (CSV)
b. Record Rendering
c. Document Storage and Retention
d. System Access
e. Audit Trails
f. Workflows
g. Authority Checks
h. Device Checks
i. Personnel Qualifications
j. Personnel Accountability
k. Document Control -
Additionally, systems categorized as “Open” (as defined in Subpart A) require further procedures and controls. Electronic signatures must include:
- The printed name of the signer
- The date and time of the signature
- The meaning of the signature -
Electronic signatures must remain permanently linked to their corresponding records.
SUBPART C – ELECTRONIC SIGNATURES
-
Organizations planning to implement electronic signatures must notify the FDA in writing before transitioning.
-
Each person using an electronic signature must 1) have their identity verified and 2) use a unique signature that is exclusive to them and will not be used by anyone else.
-
There are distinct design requirements for electronic signatures, whether they are biometric (e.g., fingerprint scans) or non-biometric (e.g., user IDs and passwords).
-
For electronic signatures based on user IDs and passwords or passcodes, there are specific requirements for the passwords and the devices used to generate passcodes.
How Smart Food Safe Can Be Your Tech-Enabler in Complying With 21 CFR Part 11
When it comes to ensuring your business’ regulatory requirements with regard to electronic systems meet 21 CFR Part 11 standards, it can seem overwhelming. But no worries, Smart Food Safe solutions demonstrate how to make compliance easy and effortless. This platform provides a streamlined, purpose-built solution designed to tackle common compliance issues, ensuring your electronic food safety systems are up to standard with the latest regulations and best practices.
Compliance Issues Faced
Smart Food Safe’s Solutions
SUBPART B – ELECTRONIC RECORDS
11.10 Controls for Closed Systems
-
Unauthorized Record Deletion/Tampering: Risk of records being deleted or altered without proper oversight.
-
Accurate and Complete Records: Records are exportable in PDF and Excel formats, maintaining data integrity for regulatory reviews.
-
Record Protection: Records cannot be deleted but only archived, ensuring they are accessible at any time while preserving their integrity.
-
Lack of Traceability: Difficulty in tracking changes or actions related to records.
-
Audit Trails: All record activities are logged in real-time, capturing user details and timestamps, ensuring accountability and compliance.
-
Inadequate User Access Controls: Unrestricted access leads to potential unauthorized actions or data breaches.
-
Limited Access: Only authorized users can access the platform, secured by unique credentials, with optional two-factor authentication and Single Sign-On.
-
Authority Checks: Access is role-based, with different permissions for operators and managers, and workflows control access to specific actions.
-
Controlled Accessibility: Access is limited based on user roles and workflows, ensuring proper access management and audit trail generation.
-
Insufficient Training on Usage: Users may not manage records correctly due to a lack of adequate training.
-
Training: Onboarding includes customized training and the Smart Training module, ensuring users can effectively manage electronic records.
-
Weak Accountability: Challenges in ensuring the integrity and authenticity of user actions on records.
-
Accountability: Role-based responsibilities and secure, unfalsifiable electronic signatures ensure traceability and integrity.
11.30 Controls for Open Systems
-
Data Leakage or Interception: Potential for data compromise or leakage.
-
Tenant Isolation: Segregation of tenants within the shared infrastructure to prevent data compromise.
-
Role Misalignment: Issues arising from allowing inappropriate access to critical environments.
-
Segregation of Duties: Restricted access to production environments based on job roles.
-
Downtime, Data Loss & Performance Concerns: Potential system downtime or decreased performance or availability of services risking data loss.
-
Serverless Architecture: High availability, seamless deployment, and monitoring across multiple zones.
-
Data Backup: Automated backups with fast recovery times, ensuring RTO and RPO compliance.
-
Security Compliance: Follows AWS security standards like SOC 2, and ISO 27001.
-
Technical Weaknesses: Unaddressed vulnerabilities leading to possible exposure to security threats
-
Vulnerability Management: Continuous network scans and vulnerability assessments along with regular security testing.
-
Product Roadmap & QA: Security fixes are reviewed periodically, and rigorous testing ensures stable and secure software updates.
11.50 Signature Manifestations
-
Integrity of Electronic Signatures: Informal sign-offs often lack essential details, resulting in confusion or compliance failures as there is no reliable verification of who approved what and when.
-
Digital Sign-offs: Digital sign-offs in Smart Food Safe include the meaning of the signature, the signer’s name, and the date/time. These elements are strictly controlled and appear in all forms of the record, whether electronic or printed.
-
Layered Security Measures: Security layers ensure the authenticity and security of electronic signatures.
11.70 Signature/Record Linking
-
Lack of Traceability Associated With Electronic Signatures: Inadequate controls over electronic signatures can result in unauthorized changes, tampering, or forgery of signatures on critical records.
-
Linkage of Electronic Signatures to Records: Electronic signatures are automatically linked to their records and cannot be removed, copied, or altered. Signatures are generated when users take action on records and are protected from modification.
-
Audit Logs: Audit logs capture these signatures and are safeguarded against deletion or tampering.
-
Secure User Signatures: Users sign records using unique credentials, ensuring that signatures cannot be forged or misused.
SUBPART C – ELECTRONIC SIGNATURES
11.200 Electronic Signature Components and Controls
-
Insecure Authentication Methods: Weak authentication practices can result in unauthorized access and data breaches, impacting the authenticity and integrity of electronic documents.
-
Unique Username & Password: Identity is verified through a unique username and password for actions like creating or modifying documents.
-
Strong Authentication Mechanisms: Additional security options include two-step authentication, strengthened password policies, and single sign-on.
11.300 Controls for Identification Codes/Passwords
-
Inefficient Authentication: Single-factor authentication is susceptible to security breaches.
-
Customizable Password Policies: Customizable password policies allow for flexibility, including password reset options.
-
Two-Step Authentication: Two-step authentication is available for added security, requiring a verification code sent to a registered email.
-
Poor Visibility of User Activities: Lack of visibility into user activities can delay the detection of suspicious behavior or security threats.
-
Real-Time Activity Monitoring: Real-time activity logs track login details, browser info, IP addresses, and more to detect anomalies.
If you are an FDA-regulated industry, you must be familiar with one of the FDA’s key premises for operations; if you didn’t document it, you didn’t do it. This notion exemplifies the significance of maintaining compliant documentation based on the established FDA predicate rules.
A vital requirement in this context is the 21 CFR Part 11 regulation. It is a section of the Code of Federal Regulations (CFR) issued by the FDA outlining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
What is Meant By 21 CFR Part 11?
Breaking down the meaning of “21 CFR Part 11” involves:
- 21 refers to “Title 21,” which is the section of the Code of Federal Regulations (CFR) dedicated to regulations for food and drugs. The CFR itself is divided into 50 different titles.
- CFR stands for “Code of Federal Regulations,” a collection of laws organized by numbers and letters, published by the U.S. federal government.
- Part 11 focuses specifically on the regulations surrounding electronic records and electronic signatures, including those submitted electronically to the FDA.
Interpreting 21 CFR Part 11 Regulations
Specifically, 21 CFR Part 11 means: Title 21 > Chapter 1 > Subchapter A > Part 11. The 21 CFR Part 11 regulation is divided into three subparts:
SUBPART A – GENERAL PROVISIONS
11.1 – Scope
11.2 – Implementation
11.3 – Definitions
SUBPART B – ELECTRONIC RECORDS
11.10 – Controls for closed systems
11.30 – Controls for open systems
11.50 – Signature manifestations
11.70 – Signature/record linking
SUBPART C – ELECTRONIC SIGNATURES
11.100 – General requirements
11.200 – Electronic signature components and controls
11.300 – Controls for identification codes/passwords
Here’s a summarized interpretation encompassing the key takeaways from 21 CFR Part 11 Subparts and Sections:
Food Safety Management Software
Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.
Food Safety Management Software
Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.
SUBPART A – GENERAL PROVISIONS
-
Part 11 applies to all electronic records governed by FDA regulations.
-
If an organization proves to an auditor that its electronic records and signatures are as reliable as paper records and handwritten signatures, the FDA will accept electronic versions.
-
The FDA will accept electronic submissions instead of paper if:
- They comply with Part 11 requirements.
- They are among the document types the FDA allows for electronic submission.
SUBPART B – ELECTRONIC RECORDS
-
Organizations utilizing electronic records must establish and document procedures and controls to ensure the following attributes in their records:
- Authenticity
- Integrity
- Confidentiality (when applicable)
- Irrefutability (i.e., the record cannot be disputed as genuine) -
Documented procedures and controls must cover:
a. Computer Systems Validation (CSV)
b. Record Rendering
c. Document Storage and Retention
d. System Access
e. Audit Trails
f. Workflows
g. Authority Checks
h. Device Checks
i. Personnel Qualifications
j. Personnel Accountability
k. Document Control -
Additionally, systems categorized as “Open” (as defined in Subpart A) require further procedures and controls. Electronic signatures must include:
- The printed name of the signer
- The date and time of the signature
- The meaning of the signature -
Electronic signatures must remain permanently linked to their corresponding records.
SUBPART C – ELECTRONIC SIGNATURES
-
Organizations planning to implement electronic signatures must notify the FDA in writing before transitioning.
-
Each person using an electronic signature must 1) have their identity verified and 2) use a unique signature that is exclusive to them and will not be used by anyone else.
-
There are distinct design requirements for electronic signatures, whether they are biometric (e.g., fingerprint scans) or non-biometric (e.g., user IDs and passwords).
-
For electronic signatures based on user IDs and passwords or passcodes, there are specific requirements for the passwords and the devices used to generate passcodes.
How Smart Food Safe Can Be Your Tech-Enabler in Complying With 21 CFR Part 11
When it comes to ensuring your business’ regulatory requirements with regard to electronic systems meet 21 CFR Part 11 standards, it can seem overwhelming. But no worries, Smart Food Safe solutions demonstrate how to make compliance easy and effortless. This platform provides a streamlined, purpose-built solution designed to tackle common compliance issues, ensuring your electronic food safety systems are up to standard with the latest regulations and best practices.
SUBPART B – ELECTRONIC RECORDS
11.10 Controls for Closed Systems
Compliance Issues Faced
-
Unauthorized Record Deletion/Tampering: Risk of records being deleted or altered without proper oversight.
Smart Food Safe’s Solutions
-
Accurate and Complete Records: Records are exportable in PDF and Excel formats, maintaining data integrity for regulatory reviews.
-
Record Protection: Records cannot be deleted but only archived, ensuring they are accessible at any time while preserving their integrity.
Compliance Issues Faced
-
Lack of Traceability: Difficulty in tracking changes or actions related to records.
Smart Food Safe’s Solutions
-
Audit Trails: All record activities are logged in real-time, capturing user details and timestamps, ensuring accountability and compliance.
Compliance Issues Faced
-
Inadequate User Access Controls: Unrestricted access leads to potential unauthorized actions or data breaches.
Smart Food Safe’s Solutions
-
Limited Access: Only authorized users can access the platform, secured by unique credentials, with optional two-factor authentication and Single Sign-On.
-
Authority Checks: Access is role-based, with different permissions for operators and managers, and workflows control access to specific actions.
-
Controlled Accessibility: Access is limited based on user roles and workflows, ensuring proper access management and audit trail generation.
Compliance Issues Faced
-
Insufficient Training on Usage: Users may not manage records correctly due to a lack of adequate training.
Smart Food Safe’s Solutions
-
Training: Onboarding includes customized training and the Smart Training module, ensuring users can effectively manage electronic records.
Compliance Issues Faced
-
Weak Accountability: Challenges in ensuring the integrity and authenticity of user actions on records.
Smart Food Safe’s Solutions
-
Accountability: Role-based responsibilities and secure, unfalsifiable electronic signatures ensure traceability and integrity.
11.30 Controls for Open Systems
Compliance Issues Faced
-
Data Leakage or Interception: Potential for data compromise or leakage.
Smart Food Safe’s Solutions
-
Tenant Isolation: Segregation of tenants within the shared infrastructure to prevent data compromise.
Compliance Issues Faced
-
Role Misalignment: Issues arising from allowing inappropriate access to critical environments.
Smart Food Safe’s Solutions
-
Segregation of Duties: Restricted access to production environments based on job roles.
Compliance Issues Faced
-
Downtime, Data Loss & Performance Concerns: Potential system downtime or decreased performance or availability of services risking data loss.
Smart Food Safe’s Solutions
-
Serverless Architecture: High availability, seamless deployment, and monitoring across multiple zones.
-
Data Backup: Automated backups with fast recovery times, ensuring RTO and RPO compliance.
-
Security Compliance: Follows AWS security standards like SOC 2, and ISO 27001.
Compliance Issues Faced
-
Technical Weaknesses: Unaddressed vulnerabilities leading to possible exposure to security threats
Smart Food Safe’s Solutions
-
Vulnerability Management: Continuous network scans and vulnerability assessments along with regular security testing.
-
Product Roadmap & QA: Security fixes are reviewed periodically, and rigorous testing ensures stable and secure software updates.
11.50 Signature Manifestations
Compliance Issues Faced
-
Integrity of Electronic Signatures: Informal sign-offs often lack essential details, resulting in confusion or compliance failures as there is no reliable verification of who approved what and when.
Smart Food Safe’s Solutions
-
Digital Sign-offs: Digital sign-offs in Smart Food Safe include the meaning of the signature, the signer’s name, and the date/time. These elements are strictly controlled and appear in all forms of the record, whether electronic or printed.
-
Layered Security Measures: Security layers ensure the authenticity and security of electronic signatures.
11.70 Signature/Record Linking
Compliance Issues Faced
-
Lack of Traceability Associated With Electronic Signatures: Inadequate controls over electronic signatures can result in unauthorized changes, tampering, or forgery of signatures on critical records.
Smart Food Safe’s Solutions
-
Linkage of Electronic Signatures to Records: Electronic signatures are automatically linked to their records and cannot be removed, copied, or altered. Signatures are generated when users take action on records and are protected from modification.
-
Audit Logs: Audit logs capture these signatures and are safeguarded against deletion or tampering.
-
Secure User Signatures: Users sign records using unique credentials, ensuring that signatures cannot be forged or misused.
SUBPART C – ELECTRONIC SIGNATURES
11.200 Electronic Signature Components and Controls
Compliance Issues Faced
-
Insecure Authentication Methods: Weak authentication practices can result in unauthorized access and data breaches, impacting the authenticity and integrity of electronic documents.
Smart Food Safe’s Solutions
-
Unique Username & Password: Identity is verified through a unique username and password for actions like creating or modifying documents.
-
Strong Authentication Mechanisms: Additional security options include two-step authentication, strengthened password policies, and single sign-on.
11.300 Controls for Identification Codes/Passwords
Compliance Issues Faced
-
Inefficient Authentication: Single-factor authentication is susceptible to security breaches.
Smart Food Safe’s Solutions
-
Customizable Password Policies: Customizable password policies allow for flexibility, including password reset options.
-
Two-Step Authentication: Two-step authentication is available for added security, requiring a verification code sent to a registered email.
Compliance Issues Faced
-
Poor Visibility of User Activities: Lack of visibility into user activities can delay the detection of suspicious behavior or security threats.
Smart Food Safe’s Solutions
-
Real-Time Activity Monitoring: Real-time activity logs track login details, browser info, IP addresses, and more to detect anomalies.