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
What is the Rx-360 Audit License Program?
Rx-360 is a non-profit international consortium that maintains a library of audit reports that are derived from audits that Rx-360 has executed. As a service to the pharmaceutical industry, Rx-360 makes the reports available for licensing.
What is the difference between purchasing an audit report and licensing?
Rx-360 maintains the ownership of all audit reports. The difference between licensing and purchasing a report is found in that a license is granted based on permission from the auditee, in an effort, to protect confidentiality. Licensing also protects the distribution of the report versus purchasing which could be perceived as ownership. Rx-360 does not offer the purchasing of audit reports.
Do I have to be a member of the Rx-360 Consortium to license and audit report?
The Rx-360 License Program is open to members of the pharmaceutical community regardless of whether you are an Rx-360 member or not.
Once I license an audit report, who can I share it with?
Rx-360 audit reports, when licensed, are only available to the licensee organization and their approved affiliates as defined in the Rx-360 License Agreement. The License Agreement must be signed before access to the audit report is granted.
What does an Rx-360 License cost?
The list price for an Rx-360 Audit is $5000.00. Rx-360 members or member affiliated licenses, receive a 50% discount.
Is licensing an audit report less expensive or more expensive than sponsoring an audit at Rx-360?
That depends on the situation. The cost of an Rx-360 audit license is a set fee schedule. That fee schedule is based on the license being member affiliated or not. The cost of sponsoring an Rx-360 audit (AKA having Rx-360 execute an audit on your behalf) is variable based on several factors, such as number of co-sponsors, and scope of audit. For more information on audit sponsorship, and our license fee schedule, please contact Rx-360 at email@example.com
Can Rx-360 license audit reports without permission of the auditee?
Rx-360 will not license an audit report to anyone without the auditee granting permission for the report to be released to that particular requesting company.
How can I view the audit reports at Rx-360 that are available for licensing?
The list of Licensable audit reports can be viewed via the Rx-360 website at www.rx-360.org, or by emailing us at firstname.lastname@example.org for a sortable list.
Can I view the audit report contents before licensing?
The confidential details of the audit (including observation details) cannot be disclosed prior to the completion of the license transaction. However, Rx-360 can supply you with the redacted cover page of the audit report for your viewing. This will allow you to see the basic details about the audit: auditee address, audit date, scope and the materials that were audited. The intention is to provide you with sufficient information to make an informed decision to move forward with the license process or not.
Once I place an order to license an audit report, how long does it take to receive?
Rx-360 members receive the licensed audit report package along with the invoice (after auditee permission has been secured and the License Agreement is executed). For companies who are not Rx-360 members, after auditee permission has been secured and the License Agreement is executed, the prepayment invoice will be provided; payment must be received by Rx-360 before we will deliver the licensed audit report package.
Do Rx-360 Audit Reports expire?
Rx-360 maintains all our audit reports within our library and they remain available for licensing indefinitely. Each report is listed with the date of the audit, and they do not inherently expire. Rx-360 relies on the licensee to recognize whether the date of the audit falls within their own internal compliance rules and regulations for validity. Rx-360 endeavors to secure re-audits at supplier sites in typical audit cycle frequencies, however customer sponsorship is what allows us to maintain a current audit library.
Are the suppliers formally certified by hosting an Rx-360 audit?
No, Rx-360 audits do not represent any kind of certification. They are audit reports made available for licensing in order to reduce industry audit burden. They do not inherently represent any formal status or certification.
What is included in a Licensed Audit Package?
When you license an audit report from Rx-360 you will receive: auditor qualifications, audit agenda, audit report, CAPA documentation (if applicable) and closing letter.
How do I inquire about licensing an audit report?
You may reach out to Rx-360 at email@example.com to inquire about the License Program, the Audit Program in total, or how to become an Rx-360 Consortium Member.
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