Audit Services

With its qualified lead auditors and trained internal auditors, MedWatch Global offers to take over your external or internal audit program.

Competent authorities and certification organizations demand more frequently that manufacturers of pharmaceuticals and medical devices audit their service providers, suppliers, and internal operations.

Do you lack the internal know-how or time necessary to carry out these audits? With our certified Lead Auditors or expert internal auditors, MedWatch Global offers to take over your external or internal audit programme.

Please get in touch with us if you want more details about our auditing services.

Types of Audit

First party

Internal audits, also referred to as first-party audits or self-inspections, are mandated by the standards ISO 9001, ISO 13485, and GMP. The goal is to verify that the QMS and production processes adhere to corporate policies, as well as to legal and customer requirements.

Second party

Internal audits, also referred to as first-party audits or self-inspections, are mandated by the standards ISO 9001, ISO 13485, and GMP. The goal is to verify that the QMS and production processes adhere to corporate policies, as well as to legal and customer requirements.

Third party

Companies are routinely inspected by regulatory and/or notified organizations in order to receive a QMS ISO certificate or a GMP/GDP license. An independent auditor’s or consultant’s full-system audit is also regarded as a third-party audit.

Why go for Audit ?

Consider audits as more than just a requirement. Any audit is a chance to learn more about the business and the quality management system.

Even though the goal of an audit is to establish proof of conformance and compliance, it is normal to find gaps or non-conformities.

The company is given the chance to learn and continuously improve by identifying suitable corrective and preventive actions.

Challenges while conducting Audit:
  • Internal auditors must be impartial towards the area they are auditing, although this can be challenging, particularly in smaller businesses.
  • The (lead) auditor for supplier audits should be knowledgeable and certified by a recognized training organization.
  • Internal auditors are extremely knowledgeable about the company’s internal processes, but they frequently lack familiarity with regulatory texts like ISO standards or GMP/GDP. The internal auditor may develop tunnel vision as a result of this.
  • Internal and supplier audits may be given insufficient time, or the (lead) auditor may not have enough time to complete the audit. Audits then turn into a necessary “check box” rather than a way to always get better.

Procedure of Audit:

1. Preparation

The allocated auditor will meet with the MedWatch Global business development team after the initial contact to ensure that expectations are understood and aligned. Together with the audit client, the objective, scope, and criteria will be established.

2. Agenda

At least one week before the audit takes place, an agenda will be shared with the audit client or auditee.

3. Audit location

The audit will take place either on-site or remotely, as requested.

4. Audit Execution

The MedWatch Global auditor will take their time during the audit to thoroughly evaluate each item on the agenda. The auditor will examine policies and records, speak with important individuals, and observe while on a site visit. Meeting with the auditee will serve as both the audit’s opening and closing.

5. Reports

The MedWatch Global auditor will produce a thorough report following the audit. This report includes a summary of the audit activities carried out, their conclusions, a list of specific non-conformities to the audit criteria, and suggestions for improvement.

6. Follow Up

The audit client is responsible for the follow-up of an action plan to correct the discovered non-conformities. However, the MedWatch Global auditor can analyze the offered action plan and offer feedback on whether the suggested activities are sufficient upon request.