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Meet complex labeling requirements effortlessly through comprehensive data security and auditing measures with Artwork Flow.
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Protect closed systems from unsecured access
All access to Artwork Flow is secured by the highest standards of data protection. Dedicated access control measures and a multi-tenancy architecture effectively eliminate the possibility of unsecured access to your organization’s data.
Keep your data from ever getting lost
Artwork Flow backs up all your data on a daily basis to protect your work at all times. In case any data loss occurs, our team has a recovery plan in place to instantly restore any data you might have lost and your projects can proceed without a hitch.
Record all activities with audit trails
Maintain a list of all activities carried out by your team to ensure 21 CFR compliance. Your audit trail will include everything from detailed user information to timestamps on activities, with audit access provided exclusively to system administrators.
Maintain role-based access control
Artwork Flow's authority checks allow you to define roles within your team and decide who can access sensitive information during reviews. You can also lock accounts that may have been compromised and reset passwords immediately.
Ensure accountability with e-signatures
Aid compliance with Part 11 of 21 CFR by using e-signatures to validate reviews and approvals. Each electronically recorded signature on Artwork Flow contains the user's name, along with the date and time of the signature.
Track changes with version control
Stay up to date on changes made to your assets during every project with version control. Artwork Flow maintains all versions of your asset on the cloud, allowing you to compare different versions or download any version whenever you need it.
What our customers say
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What our customers say
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What our customers say
What our customers say
What our customers say
What our customers say
What our customers say
What our customers say
What is 21 CFR?
The Code of Federal Regulations (CFR) lists general rules all food products, cosmetics, and medical devices must adhere to if they want to be sold within the United States.
Title 21 of the Code of Federal Regulations lists regulations pertaining to food and drugs within the United States.
Failure to comply with these regulations leads to misbranding and product recalls, damaging your reputation, and brand image.
What is Part 11 of 21 CFR?
Part 11 of the 21 CFR deals with regulations on electronic records and electronic signatures for companies selling food and drugs within the United States.
How to comply with 21 CFR Part 11 using Artwork Flow?
To ensure compliance with 21 CFR Part 11, Artwork Flow allows customers to have:
Controls for closed systems:
- Access to Artwork Flow is performed via authentication using a combination of email address and password, which follows a minimum security standard.
- All data transmissions to and from Artwork Flow use a secure HTTPS connection and are encrypted.
- Access to servers is restricted by access and only available through SSL.
- Artwork Flow has multi-tenancy architecture implemented at data level. Each request consists of a secure client key, and all database queries include that key by default. This makes it impossible for any unsecure access to client’s data.
- For feature level and role based access control (RABC), we have a dedicated access-control service that is responsible for authorizing each request.
- Enabling program time-outs so that the system enters into a locked state when the program is not used for an extended period of time.
- Functions enabling the system administrator to keep checks on selected tasks and permissions that require security and its efficiency.
Data retention:
- All client data is backed up daily with a retention period of 7 days.
- In the event of an incident involving data loss, we have a Disaster Recovery plan that includes a Backup & Restore from the last recovery point (daily backup) and ensure that the recovery process is fast and smooth.
Audit trails:
- Complete audit trail including user details, timestamp and all transitions and activities are captured.
- System administrator to access audit trails with automated versioning and history tracking enabled.
Authority checks to ensure that only authorized individuals can use the system:
- System administrator has complete control on providing access to individual users, defining their roles and access levels.
- Secure sensitive information during the review and artwork approval process through Role Based Access Control.
- Enables administrators to lock user accounts to prevent use of compromised credentials. Administrators also can reset user passwords.
Electronically sign a record & signature manifestations:
- Automate the production workflow to receive e-signatures from internal and external stakeholders securely.
- Signed electronic records contain the printed name of the signer, the date and time when the signature was executed.
Revision and change control procedures:
- Follows standard change control procedure to ensure that our customers have proper manuals and documents available.
- Manage all assets in one library and track changes with version control.
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