IQ/OQ/PQ Secure software validation work book and software package. To help our customers meet the requirements of CFR 21 Part 11, we have secure validation software compatible with some of our registrars. The software guarantees the standard in which electronic files are considered equivalent to paper documents, saving time and effort. MT Secure Software has features such as electronic signatures, access codes, secure data archiving, and audit trails that meet the requirements of CFR 21 Part 11, helping to provide IQ / OQ / PQ protocols, which provide integrity to the data, which can be purchased and implemented to validate that the software has been installed and is working properly.
The design of the secure software is similar to the standard software version of some of our registrars, allowing users to easily learn the additional features. The software is not compatible with all data loggers we handle. See list of unsupported registers here.
Includes an unlimited users license for a PC, in addition to the Protocols book.
The protocol book allows the validation of the secure data logger system with CFR 21 Part 11, in an end user environment. The protocols serve to indicate that the system has been received as specified, is properly installed on the computer in the selected environment, that this environment is appropriate for system use and communication between the data logger and the computer is done correctly . This book helps verify that all of these points are met.
Features and benefits: - Install, validate and use a universal software program.
- Saving time and costs in validation packages and auditors.
- Data security and automatic auditing.
- Sophisticated User Maintenance.
- Traceability with customizable electronic signatures.
- Helps to comply with CFR 21 Part 11/820 and the GxP guidelines.
Applications: - Pharmaceutical.
- Médicina Hospitals.
- Organizations regulated by the FDA.
- Temperature records.
