DO YOU COMPLY WITH FDA 21 CFR PART 11?

 

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  • System tested and validated
  • Full control of permissions with secure access
  • Track all system changes with full audit trail
  • Full product data lifecycle management
  • Minimise risk with review and approval workflows
  • Electronic signatures and date & time stamps at each stage
  • Archive history of all deleted records
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WHAT IS FDA 21 CRF PART 11?

Part 11 as it is commonly called applies to FDA-regulated industries to determine how the industry deals with electronic record keeping systems and defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

 

FULL AUDIT TRAIL

Part 11 compliance requires that records created, modified or deleted in a system are recorded and stored in a secure manner. Each entry into the audit trail must be date and time stamped using either a secure server or local computer controlled clock that cannot be altered and must record the individual who made the changes. In addition, records in an audit trail cannot be edited or deleted and previous changes must not be overwritten. To meet these requirements Kodit’s kUDID system has a full audit history module which shows the lifecycle of every record in the system of what changes were made, by whom and when.

 
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SYSTEM VALIDATION

It is the responsibility of companies to validate their system as part of the electronic record system. Part 11 states that ‘procedures should be in place for validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records’. Fulfilling procedural requirements involves the establishment of standard operating procedures (SOPs) which must be followed by users. These procedures include the training of users, the control of system documentation and the control of system access. Kodit can help you with your  validation plan documentation as all of our systems have been fully validated.

 

ARCHIVING RECORDS

The FDA stipulate that records cannot be deleted without a traceable trail of the record. Records must be protected to enable their accurate and ready retrieval throughout the records retention period. In addition, systems must have 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. Kodit’s kUDID system allows records to be deleted to keep your system clean of outdated data but all deletions are captured and stored in an archive section which can be restored but never deleted from the system.

 
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SYSTEM SECURITY

Closed systems should have secure passwords which can be retrieved when lost and use authority checks to ensure that only authorised individuals can use the system and electronically sign a record. In some circumstances of signing electronic records the FDA will require a paper submission giving the authority to sign records electronically. It is the responsibility of the company to assign the appropriate user role to each individual depending on the desired level of authorisation so that only authorised users can add or delete files, change software settings or create additional user accounts. Kodit’s kUDID system has full roles and permissions to restrict user actions and meets all the password requirements.

 
 

SEQUENCING

Sequencing is the use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. kUDID has introduced a series of review and approval workflows to help the user complete step by step procedures.

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