IntellaPac Pro
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21 CFR
Requirement Assessment
Audit Trails -- COMPLIANT The independent and non-modifiable Audit function provides for secure, computer-generated date / time stamped records of record changes and key operator entries and activities. Actions that create, modify or delete records are retained for viewing / printing.
System Security -- COMPLIANT The INTELLAPAC PRO provides for initial and periodic testing, as well as periodic reviews and revisions. Password expiration dates are defined and set by the Administrator (from 10 - 90 days in 5 day increments). Only the Administrator has access to Security Maintenance. Passwords can never be reused.
Record Retention, Protection, Retrievability, and Reproducibility -- COMPLIANT The INTELLAPAC PRO has been designed and tested to accurately retrieve and generate all reports and database records. All electronically stored records are validated to be able to be accurately generated, retained, protected, and readily retrieved in both "human readable and electronic form", throughout the retention period. A validated archive and unarchive feature further adds to the record retention and reporting capability.
Operational Checks -- COMPLIANT Where necessary, the appropriate operational checks have been put in place to enforce step and event sequencing. The program will only allow you to perform events in the appropriate sequence. It is not possible to perform certain steps before others are complete.
Password Security -- COMPLIANT Controls ensure the security, integrity, and uniqueness of the identification and password combination used for electronic signature. Passwords must be between 6 and 8 characters. Each username is unique, so two users cannot have the same username and password combination.
Electronic Signature Assignment -- COMPLIANT Each user's unique electronic signature cannot be reused or reassigned to another user. Each username and password is unique. Once a password expires it can never be reused again by anyone.
Electronic Signatures Not Based Upon Biometrics -- COMPLIANT Both a user name and password are required for initial login. Both are required on subsequent logins when security logoff has occurred due to inactivity in the INTELLAPAC PRO, or when access to specific functions is necessary.
Electronic Signature With Biometric Links -- COMPLIANT The system is designed to preclude use by anyone except a genuine user. If an individual is not established in the User Maintenance database there is no ability to access the INTELLAPAC PRO.
Name Display The printed name of the individual who signs a record electronically is always clearly displayed. His / her user name will appear on relevant documents and reports generated by the program..
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Contact Info
IntellaPac, PRO.
1383 Dublin Rd. Columbus, Oh. 43215