Audits & Inspections

The scenario:

You need independent eyes for an internal audit. You need assistance to audit a supplier or partner. You want to check your inspection readiness to be well prepared before a regulatory inspection

Get an independant and professional outside perspective!

From time to time, your company may see the benefit of using an outside auditor for both your internal audits and supplier audits. Such an audit performed by one of our experienced auditors will help you to get documented evidence that audit objectives are fulfilled. And if the outcome indicates that improvements are needed, the audit report will be an effective tool for your continued work to get into compliance if needed.

VeraCQ Founder - Maria

GAP analysis or audit?

In my role as QA manager, I have seen that in certain situations, a GAP analysis is a very good first step for a newly established organisation. With a GAP analysis, it is possible to work in parallell with identifying areas for improvement and discuss the solutions which you normally avoid in a normal audit situation. Our team at Vera can help you with both these activities since you can get different persons for these separate activities. When we know more about your specific needs, we will happily propose a suitable solution!

GAP analysis, audit or "inspection readiness"?

Depending on your need, the best solution to your situation may be either one of these options, a combination of them or something truly customized. Just get in touch so we can discuss it!

GAP analysis

A GAP analysis is a very good tool especially when you are still in a development phase, your quality system (or a specific process) is not yet fully set and implemented but you need an outside eay to identify areas where you are unsure about suitable level or need hands-on recommendation how to achieve a certain compliance level. We work similar to the audit approach but it is also recommendations and knowledge sharing to refine and improve your SOPs and processes.

Internal audit and supplier audit

Your audit criteria may vary, EU GMP for APIs or medicinal products, FDA cGMPS and QMSR for drugs and devices, ISO 13485, ISO 9001 and/or supplier contracts. Lead Auditors from Vera will bring broad experience and competence for the audit at hand. We work with the ISO 19011 standard as a base for identifying criteria, establishing objectives, creating checklists, performing the audit, and writing the audit report - of course in collaboration with you and adapted to your SOPs if needed.

Inspection readiness

Do you need support in preparation for an upcoming inspection from a Competent Authority or Notified Body? We can help you in several ways, both with pre-audit and a very formal "mock" audit - the latter to really make sure that your organisation is prepared for the inspection situation. And as a part or an add-on, we can of course also perform a training session as a part of the process for your complete team to be ready.

The audit principles we adhere to!

The International standard ISO 19011 has been a gold standard for auditors and inspectors for many years. The latest version from 2026 still stick to 7 principles which we at Vera also use as core principles for our audits.

Integrity
Fair Presentation
Due Professional Care
Confidentiality
Independence
Evidence-Based Approach
Risk-Based Approach

What audit task do you need help with?

Supplier audit - domestic Supplier audit - abroad Internal audit - pharma GMPs Internal audit - medical device quality systems GAP analysis

QA consultants & support

Scenario:

Your QA team need a shorter or more extensive support for specific situations, e.g. setting up a regulatory strategy, handling Risk, CAPA and Change Management.

QA consultants & support

Training & Workshops

Scenario:
You need to ensure that all personnel have basic and updated knowledge about GMP or Quality System requirements. You need specific knowledge for certain groups of personnel, e.g. Risk management, Qualification and Validation, Change management, CAPA and more.

Training & Workshops