Halle/Westfalen Audit Guide
AN AUDIT TO MEET YOUR NEEDS
At Simtra BioPharma Solutions in Halle/Westfalen, Germany, we regularly conduct audits of our facility and its operating practices for both regulatory authorities and customers. Whether audits take place on site or remotely, we seek to thoroughly demonstrate our compliance with current GMP guidelines and to use audit results to continuously improve our quality performance, as part of our mission to save and sustain lives.
YOUR AUDIT REQUEST
Your audit request must include complete names and contact details for your audit team, and you must let us know if anyone on your team is an external consultant. As soon as we receive your request, we will assign one of our team members to act as your designated liaison and provide their contact information.
You can schedule an on-site audit between 9 a.m. and 5 p.m. CET. Remote audits are also scheduled during the regular business day at a mutually agreed time. Please take any time zone differences into consideration when you schedule your audit.
YOUR AUDIT AGENDA
Once you have scheduled your audit, we will need to know its primary focus and any set requirements you may have. We can provide you with a standard agenda for the audit, or you can provide your own customized agenda, which we will need at least seven business days prior to your scheduled audit. The agenda helps us to ensure that your audit is conducted by Simtra BioPharma Solutions staff members with the proper expertise.
REQUIRED DOCUMENTS
Before your audit, we request that you send us a list of the topics you want to cover and the Simtra BioPharma Solutions documents you want to review so that we can make them readily available during the audit. If your audit is to be conducted remotely, we will provide you with as many documents as possible beforehand, but please understand that we cannot send you documents containing confidential information in advance.
TOURING OUR FACILITY
During an on-site audit, we will tour the facility, except for Class A, B and C clean rooms, where visitors cannot enter. As part of the audit, we will provide flowcharts and layouts to help you gain a full understanding of the operations taking place.
If you would like to see a particular area of the facility, please let us know in advance so we can arrange your tour accordingly. Please also let us know in advance if you would like to observe a computer system in operation. We take data integrity seriously and will want to prepare for this.
Throughout the tour, we will ask you to stay within your group and to refrain from opening doors or cabinets, touching anything or filming employees at work. We will also ask you to wear hazmat goggles, coveralls and booties (so no high heels, please), which we will provide. We want you to be safe and comfortable during your visit.
DOCUMENT REVIEW
Document reviews will be conducted by a subject matter expert, who will present the information and answer questions, and an audit specialist, who will provide support.
For on-site audits, participants may separate into two smaller groups if desired. For remote audits, document reviews will utilize online conferencing (Zoom or Microsoft Teams). Translation will be available if needed.