I have heard a lot about the Rx-360 Joint Audit Program®, what is it?
The Rx-360 Joint Audit Program® is designed as a unique approach to executing audits using our Joint Audit Program® as well as licensing already completed audit reports. The program is specifically designed by Rx-360 members to help reduce audit costs industry-wide and be adjunctive to your own supplier audit program.
Can Rx-360 expedite an audit for my organization if I need it right away?
Rx-360 as a non-profit follows a very defined step-by-step approach within the Joint Audit Program®. Our approach ensures that confidentiality between all parties is protected and that all audit stakeholders are aligned on the audit specifics and process. In most cases due to that approach, it is very difficult to expedite an audit. Rx-360 however will always research opportunities to meet our member needs.
I have heard the program described as a Joint Audit Program®, what does that mean?
Rx-360 has a mission within our audit program, to reduce industry burden and costs associated with supplier auditing. Through the Rx-360 Joint Audit Program® we can match sponsors confidentially for a specific audit. The sponsors ‘join’ together to have a single collaborative audit conducted, while Rx-360 maintains confidentiality for the sponsors. This allows for the cost of the audit to be shared among the sponsors, reducing cost burden for them, as well as overhead and time burden for the auditee.
Can I request to be the only sponsor on an audit, or do I have to partner with co-sponsors?
Rx-360 does allow for sole sponsorship in some cases.
How does Rx-360 find co-sponsors on my behalf and how long does it take?
Rx-360 will proactively seek out co-sponsors on your behalf (confidentiality) through our membership and industry customers. Rx-360 will work with you on an appropriate timeline to secure co-sponsors that meets your needs and expectations.
I am a pharmaceutical supplier; can I sponsor an audit of my facility?
In some cases, Rx-360 will allow for suppliers to sponsor an audit of their own facility (“self-sponsoring”).
I have heard that the Rx-360 Audit Program is described as being “no cost” to me. What does that mean?
As part of our non-profit mission, Rx-360 offers a unique credit program to our members that allows for audit expense to be greatly reduced through program utilization. For more information on the Rx-360 Credit program, please contact us directly at firstname.lastname@example.org
Does Rx-360 assist in managing the observations that result from an audit?
Rx-360 will assist in managing the CAPA process to address observations that result from an Rx-360 audit, by proactively interfacing with all parties involved: the auditee, sponsors, and auditor, following the CAPA process through to completion. This management is a required component of the audit and cannot be removed or transferred.
A supplier declined my request to conduct an audit. Can Rx-360 facilitate an audit at that facility for me?
Rx-360 is dedicated to helping our members in every way possible. We are glad to discuss with the supplier the benefits of the Rx-360 Audit Program, and its value to them. Our hope is that this education allows us to conduct the audit, but if a previous audit request was already declined, our access may also be limited.
Does Rx-360 employ its own auditors?
Rx-360 works with third party auditors around the world. The breadth of auditors allows for our members to choose a partner that best fits their needs.
Does Rx-360 handle all the communication with the auditor and auditee (supplier)?
Because of confidentiality among sponsors and protecting the scope of the audit, Rx-360 acts as the point communicator for the entire scope of work. Rx-360 directly handles all communication with sponsors, and is included in any direct communication between auditor and auditee.
How does Rx-360 categorize observations found during an audit?
Rx-360 audit reports are used by a variety of customers, and each specific user may have different ways of categorizing audit observations, we don’t want to impose any judgements of our own onto the levels of the observations. We allow the customers to categorize the observations individually, according to their own internal procedures. Rx-360 uses 2 categories for audit observations within the final report: “Potentially Critical”, and “Other”. The auditor determines whether any of the observations would be considered Potentially Critical, and if it is not, then it is considered Other.
What criteria or standards does Rx-360 use when conducting an audit?
All Rx-360 Audit Checklists are developed by our membership. They are wide-ranging and allow for Rx-360 to meet industry needs. For a complete list of our audit checklists please contact us directly at email@example.com
Can I use the Rx-360 Audit Program as a non-member? Are there benefits to becoming a member of the Consortium when it relates to the Audit Program?
The Rx-360 Audit Program is open to all manufacturers and suppliers within the pharmaceutical industry. Rx-360 Members can receive discounts for services within the program, as well as specialized reports, access to the auditsPlus® Database, and inclusion in the Credit Program. For more information, please contact us at firstname.lastname@example.org