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21 CFR Part 11 is a US FDA Code of Federal Regulations (CFR) guideline for a computer system that is used to manage and store electronic records and electronic signatures. It helps companies to define the rules under which electronic signatures and records are considered to be original, accurate, trustworthy, confidential, reliable and equivalent to paper records and handwritten signature.

21 CFR Part 11 Requirement Does Qualityze Comply? How
The system must be capable to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying. Yes Qualityze suite comes with broad range of key reports and quality metrics. Additionally, Qualityze provides capability to create custom reports. All these reports can be printed in paper or downloaded in electronic format.
Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Yes Qualityze’s Software Test Lifecycle process was designed to support the FDA’s guidelines.  A lot of rigor and process is in place to ensure the accuracy, reliability, and performance of the system.
Limiting system access to authorized individuals. Yes Qualityze is designed with security in mind. The system requires a unique user id and password to gain access. Also, access to different modules and function are controlled with a combination of roles and rights.
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 Yes Qualityze keeps the history of all the activities that the user performs in relation with Insert, Update and Delete of all the transactional records.
Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. Yes Qualityze system provides the capability for the customer to pre-define the sequencing for each record. Once the sequencing is defined, the system will ensure that the pre-defined steps are executed as specified. Also, the system comes with pre-defined validation rules to enforce the execution of the pre-defined sequence.
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. Yes Qualityze system requires a unique user id and password to gain access. Also, access to different modules and function are controlled with a combination of roles and rights. When a record is generated, altered or modified, besides the audit trail, in some steps user id and password is required to be typed again to complete the steps.
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

  1. The printed name of the signer;
  2. The date and time when the signature was executed; and
  3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Yes Qualityze suite captures the date/time and the user information (signer’s name, role) and the meaning of the signature.

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