Audits

Audits – the DREHM way:

Exam situation, nervousness, fear of the next question, severe looks, tense atmosphere – for many, this image comes to mind when they think about an audit or inspection.

Not in our case. DREHM’s approach is different: for us, every audit is seen as a great chance, with many opportunities, such as:

  • Trust and respect:

    In our experience, getting to know each other’s partners significantly influences perspectives and improves cooperation. Whether headquarters / affiliate, license holder / distributor, principal / service provider or licensor / licensee – we have already experienced numerous audits that marked the beginning of a mutual trusting relationship.

  • Positioning and focusing on the essential:

    Even with the best understanding of guidelines and laws, a certain „system blindness“ is a natural phenomenon. An unbiased view from the outside shows the auditee which processes are functioning well and where there is still room for improvement. As part of an audit, areas to be improved are weighted and prioritized. This makes it easier to form a clear picture of where you want to go and a roadmap how to get there – even if there are many „construction sites“.

  • Support and help:

    We understand audits as a constructive process by which we identify pitfalls, help the auditee minimize existing risks, and avoid the reoccurrence of past mistakes. The auditor, in our eyes, is not meant to highlight mistakes, but to support and promote the development of the auditee. This constructive approach improves the compliance of the auditee and consequently also that of the auditing company.

  • Creative approaches and suggested solutions:

    To us, it is clear that every company and department can only work within the limits of their possibilities and that even with the greatest efforts, no miracles can be done. As long-time auditors, we have already seen a wide variety of scenarios and settings, like to share our wealth of experience and support the auditee with suggestions for improvement and possible solutions. Pragmatic approaches and viable, meaningful processes are in the foreground.

Background

High quality in production and distribution of pharmaceuticals and medical devices is not only a legal obligation, but also the aspiration that the pharmaceutical industry places on itself. Therefore, manufacturers of pharmaceuticals and medical devices are required to have their compliance with processes, requirements and internal work instructions continuously audited and verified.
At the same time, they must ensure – together with their contractual partners (manufacturers, service providers, etc.) – that they meet their requirements and of course also the legal requirements.
As a result, pharmaceutical companies must conduct a variety of different audits (external audits, internal audits, supplier audits), which are often difficult to manage in day-to-day operations.

How can we help you?

**Team Qualitätsmanagement** [Meet the Team!][5]

Team Qualitätsmanagement

Meet the Team!

Our experts bring years of audit experience – both as auditors and auditees – and are happy to assist you with audits in GMP, GDP, GVP, GSP, IT, project management, biologicals, environmental management and occupational safety.
Together with you, we look at your partners and create an audit strategy that is risk-based and fits your budget. Depending on requirements, audits can be carried out in writing, by video circuit or personally on site.
Whether creating an audit questionnaire, carrying out supplier audits, conducting self-audits or monitoring agency inspections – DREHM supports you professionally in all audit steps.
And even if you have an inspection or an audit in-house, we are happy to help with the preparation by identifying potential defects, reviewing your quality management system and preparing your employees for the unfamiliar situation. It’s a reassuring feeling to know what to expect.

Our offer at a glance:

Audit planning

  • Preparation of audit plans for 1 year (including quality risk management to determine intensity and frequency)
  • Creation of risk-based audit strategies (over 5 years)

Audit preperation

  • Preparation and assistance with agency inspections
  • Pre-inspection Audits
  • Preparation of external audits and self-inspections

Audit procedure

  • Conducting internal audits / self-inspections
  • Conducting external audits with license partners, distributors, subsidiaries, service providers etc.
  • Execution of supplier audits (along the entire production and supply chain, from the active ingredient manufacturer to the transporter – as on-site audits or as a paper audit)
  • Creation of audit checklists
  • Creation of audit questionnaires

Audit follow-up

  • Creation of audit reports
  • Monitoring of necessary corrective and preventive measures

lynx

We are happy to assist you with our knowledge and experience! Contact us here.