Auditing Services

1.

QA Audit

2.

GCP Audit

3.

GVP Audit

The most important part of audit planning - the goal (s) of audit

An effective audit is objective, independent and focused on areas where it is likely to have most impact. 

The auditor should discuss the scope of the audit with the responsible person, identify those areas where attention should be focused, and ensure that the key contacts will be available during the days selected for the audit.

Once the scope of the audit has been established, the auditor should ensure that enough time is allowed for the audit. A technical expert should be included in the audit team if necessary and should work under the direction of the auditor.

An agenda and a covering letter should be prepared for submission to the auditee to include a list of documents for review, requirements for facility tours and names or titles of personnel to be interviewed. This must be submitted in good time to allow them to confirm availability of personnel and resources. The agenda should be generated as appropriate to the scope and type of audit, and in accordance with the audit plan. 

Audit Agenda should include as minimum

  1. Name(s) and affiliation/job title of the auditor(s) 
  2. Time and date of arrival of auditor(s)
  3. Audit scope, including standards to be audited against 
  4. Approximate timings and duration for each agenda item 
  5. Opening meeting
  6. Introductions 
  7. Confirmation of agenda and audit scope 
  8. Intermediate meetings if required, where audit spans more than one day 
  9. Auditor review time Closing/exit meeting 
  10. Time of audit day or audit close.

Audit Checklist

Checklist acts ensures that all aspects of the audit scope are addressed, although the auditor must ensure that they still maintain a good overview and are not restricted by check-listed points. Interviews should be held with personnel who is responsible and carrying out the work. Their competency, regulatory knowledge and understanding of their responsibilities should be assessed during the interview process. Evidence of training plans and records should be requested and reviewed. Compliance with SOPs and regulations should be assessed.

Throughout the audit it is appropriate to request key documentation which provides evidence of the processes in place. 

A record should be kept of documentation requested to ensure it is all provided during the audit, or in some cases afterwards within an agreed timescale.

At the end of the audit, an exit or close-out meeting should be held to report any findings that have been noted during the course of the audit. 

As the findings will have already been discussed and defined during the audit, there should be no need for lengthy discussions at this stage and no surprises. Auditees should be discouraged from providing ‘instant solutions’. The timeframes for writing the report and expected response should also be explained. The auditor should establish who should receive the report and establish their availability for response.

Audit Report should include at a minimum

 
  1. Name of the organisation audited
  2. Name(s) of the auditor(s)
  3. Location of vendor 
  4. Date of audit 
  5. Audit reference number 
  6. Name of the report author 
  7. List of findings
 

In addition to this, the report may also include: 

  1. Protocol, study or contract number 
  2. Background information, audit structure, audit plan 
  3. Names, titles of all audit attendees 
  4. Finding classification and audit standard 
  5. References to specific regulations
  6. A separate list of recommendations

The report should be written in clear, concise language. 

CAPA (Corrective and Preventive Actions)

Implementation of a CAPA plan after the conduct of an audit is necessary to eliminate present and potential causes of non-conformity and prevent re-occurrence or future occurrence. Once the conduct of the audit is complete the auditor should be provided a CAPA plan to the auditee that will be utilized to remediate issues of non-compliance and potential non-compliance identified during the audit process. 

The CAPA plan should, at minimum, require the auditee to identify the root-cause of audit findings and describe whether corrective and/or preventive action will be necessary to address  the audit findings.

Our QA Director helps you to prepare for an Audit.

Josipa is QA Director and Principal GCP and GVP auditor at Proqlea Ltd. She has done more than 80 Sponsor audits over the years with more than 20 unique audit types and mock inspections. 

Linkedin

View Josipa’s Linkedin Profile for more information work expirience in “QA World”.

How can we help?

Primary services Proqlea Ltd. offers:

  • Providing a full-service “one-stop” solution for development, implementation, assessment and optimisation of QMS
  • Performing GCP and GVP audits to ensure quality and adherence to regulatory and/or compliance requirements.
  • Providing assistance with the development of a company’s QMS.
  • Providing advisory services on regulatory and compliance.
 

Whenever you want to maximize your internal audit department, seeking help from Proqlea Ltd. is the cost-effective approach to evaluate and improve QMS in your organization. It can also become beneficial when you simply do not have enough staff to properly manage QA tasks, or your staff doesn’t have the full knowledge to perform comprehensive auditing strategies tailored to your organization’s objectives.

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Email: info@proqlea.com

Josipa Draženovića 2A, 10 000 Zagreb
Croatia

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