Quality management systems in PET stem from key regulations that the FDA and other regulatory bodies enforce. Regulations such as 21 CFR Part 211 are one example of this. Under this regulation, a quality management systems definition covers the concept of a quality control unit, which is responsible for overall quality management systems. The quality control unit is primarily responsible for documentation (procedures, SOPs, policies, etc.) and control of all documents that impact product quality and safety. Naturally, PETra users can benefit from this optional functionality.
This module provides an information portal for all types of documents of value within the PET facility and not just those subject to formal change control. Principally, this PETra module makes the correct information readily available at the point of need, when needed and in a form that is easily understood. There is the option to use the built-in writer or import existing documents in Word which are subsequently only available through the closed PETra system with the benefit of compliance.
Wherever formal change control needs to be demonstrated, this module addresses the complete document management lifecycle. Every action and notification associated with the following is automatically managed, thus eliminating the need for paper chase;
- Change Requests
- Document Registers
- Change History
Documents can be stored in folders providing quick access in the context of whatever is being worked on. Additionally, documents can be linked to the applicable steps in the batch for easy access to documents instantly.
Electronic signature ability, in line with 21 CFR Part 11 regulations for Electronic Records and Electronic Signatures is available throughout the system.
Out of Specification (OOS)
In the context of PETra, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications. By utilizing this PETra function, the investigational findings are maintained within PETra and can be reported at any time and progressed to CAPA, if applicable.
Despite the fact that equipment is qualified, staff is trained and that processes have been validated, the production of PET radiopharmaceuticals can present situations where prescribed workflows are not observed or processes fail to deliver the expected results. For this reason it is important not only to define the workflows for production in "normal cases," but also to specify how such deviations are to be handled. This will ensure that acceptable product quality can be obtained even in the event of unforeseen circumstances. This optional module in PETra, through its use of predefined form, allows for efficient and consistent data capture along with immediate corrective action.
Change control is a well-known CGMP concept that focuses on managing change to prevent unintended consequences. The CGMP regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Effective change control activities are key components of any quality system. This optional PETra module empowers its users to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle.
Corrective and Preventative Action (CAPA) Management Module
CAPA is another well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. This optional PETra module provides a centralised reporting system to manage the complete CAPA lifecycle. Its implementation provides the ability to solve problems quickly and thoroughly to minimize the impact and lessen the chance of re-occurrence through the following steps;
- Remedial corrections of an identified problem
- Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem
- Preventive action to avert recurrence of a similar potential problem
This module utilizes pre-defined reports to provide a consistent process that ensures information is captured and managed effectively. The key to reliable, accurate and efficient data entry is the workflow process which PETra addresses through the use of the template that also provides the ability to upload other relevant data which may be in different formats, all within a closed system.
Notification function is very flexible and can be used for a wide range of circumstances.
Notifications can be automatically generated by PETra in response to an event – so when a monthly instrument performance test is due, an SOP is due to expire, Personnel Training Records require updating etc. the relevant staff is notified of this in advance.
The messages can be forwarded to individuals or a group of individuals based upon the notification message and its relevance. For example, if an SOP is due to expire the Author will be notified of this. Once the SOP is reviewed and updated, the Author will then set up a Notification Message such that all the individuals impacted by the revision and update of the SOP are notified.