Your Quality Management Expert

Ich nehme das letzte Audit zum Anlass, um mich bei Ihnen ganz herzlich für die schöne Zusammenarbeit zu bedanken.
Sie haben wirklich tolle und sehr gute Auditoren/Berater an der Hand und wir machen die Audits sehr gerne mit Ihnen. Zum einen weil auch wir von dem profunden Wissen profitieren, und zum anderen, weil es offene und konstruktive Audits sind, die in der Zusammenarbeit wirklich Spaß machen.

(I take our last audit as an opportunity to heartily thank you for the good collaboration. You have really outstanding and very good auditors/consultants to hand and we are very pleased to carry out audits with you. Firstly, as we profit from your deep knowledge and secondly as they are open and constructive Audits that make our cooperation a lot of fun.)

She was an absolute delight to work with throughout the whole auditing process; from the initial preparation meeting right through to the reporting stage. She made our team feel at ease (which is extremely important when conducting an internal system audit), found some very valid findings which we will be implementing, and her report was such a joy to read. The report was simple, clear and detailed -– everything we could have asked for!

(Sponsor successfully resubmitted an NDA to the FDA after it was initially rejected).

Thank you. GXP was the first vendor brought onboard for this initiative. GXPs guidance and thoughtful leadership enabled us to achieve this important milestone.  Kudos to you and the team.  I hope that we will be able to call on you again for future clinical initiatives.

Again, it was a pleasure working with you.  Thank you for all your help and I hope we have the opportunity to work with you again in the future.

Having seen what a marvellous job you are doing of getting everyone aligned, just thought I’d forward this with a request that … we use the draft as the basis of the Clinical Quality Policy.

Thank you again for completing such a comprehensive and constructive audit. It was a real pleasure to work with you and learn from your experience.

She did a fantastic job in first of all identifying the key issues in the audits themselves and then at this visit interviewing the staff to prepare them for an FDA audit.  This is a really important relationship and was always going to be a delicate balance of how we work with this site as they were the academic sponsor before it was transitioned to us, so it certainly wasn’t set up in the same way you’d expect for an industry standard study.

Her demeanour with them, her knowledge and vast experience has perfectly hit the mark at each visit and the site staff themselves have reciprocated in being very open to learning. In the close up meeting, both PIs from the studies spontaneously thanked her for her help and listed a number of specific examples of how she has done this.  Due to her friendly, open, informative and coaching approach the site staff actually seem to have enjoyed this experience, despite them feeling quite anxious at the beginning of the process.  I just wanted to acknowledge her great work here and we’re really pleased that she’ll also be auditing our UK site in the same way.