The tests to be executed under this protocol are divided into the following functional areas: The deliverables for each functional area are the signed-off test scripts with any defects noted.
Validation Report The IQ, OQ and PQ documents will together form the 21 CFR Part 11 validation report.
The FDA’s 21 CFR Part 11 guidelines describe the requirements for electronic records and signatures, including the validation of the software used to create and maintain these records.
By building upon a strong foundation, Deacom’s streamlined process for validation has proven to greatly impact the ease of validation for our customers in the medical device and pharmaceutical industries.
The basis for the operational qualification is the DEACOM test script provided, additional customer test scripts, and customer specific SOP documentation.
The test scripts include a validation of general functions, transactions, and end-user training.
Here is an overview of each required document: Validation Plan The validation plan provides a detailed list of the 21 CFR Part 11 validation activities that is conducted on the system being validated.
In general, this document should describe the approach, deliverables, and acceptance criteria for each activity.
To ensure a successful outcome, HSG cultivates an exceptional team of consultants with proven and tested capabilities in each of the leading ERP platforms.Operational Qualification The operational qualification focuses on a complete test of the system.Any system interfaces that are governed by the 21 CFR Part 11 require that these components operate according to the system specifications included in the system documentation.Installation Qualification Process The qualification documents produced during the validation process outline the relationship between c GMP best practices and DEACOM.The installation qualification verifies that all hardware and software related to DEACOM are installed in accordance with the vendor’s installation specifications.