Audit preparation in pharmaceutical companies – organising training efficiently and demonstrating compliance with certainty

Audit preparation in the pharmaceutical industry: More than just complete documentation

Internal audits, supplier audits and regulatory inspections are part of everyday life for regulated organisations. In addition to processes, documentation and quality management, these audits focus in particular on checking whether staff are sufficiently qualified and whether their training has been properly documented.

The planning, monitoring and documentation of these qualifications is an ongoing process. However, with the right tool, these tasks can be seamlessly integrated into day-to-day work, eliminating the need for intensive audit preparation in this area of quality management.

OSIANTO helps you keep track of things, reduce the administrative burden and easily provide audit-related evidence at any time.

Audit preparation for pharmaceutical companies with OSIANTO

Audit requirements relating to training and professional development

During an audit or a regulatory inspection, the focus is on the following questions, amongst others:

  • Are all staff members qualified for their roles?
  • Have the compulsory training courses been completed in full?
  • Can proof of training be provided at any time?
  • Are SOP training sessions documented?
  • Were knowledge tests carried out and assessed?
  • Can changes and training records be traced?
  • Is there a clear overview of ongoing and completed training courses?

Missing evidence or incomplete documentation can lead to complaints and often result in a considerable amount of extra work during the audit. Or they can lead to findings that subsequently need to be addressed in a CAPA plan.

Typical challenges in preparing for an audit

Many companies still manage training courses using Microsoft SharePoint, Excel spreadsheets, physical paper records or several separate systems. This often leads to:

  • A high administrative burden
  • Lack of transparency regarding training status
  • Manual tracking of training courses due
  • Time-consuming search for evidence
  • Inconsistent documentation
  • Uncertainty during audits and inspections

Particularly in the case of audits announced at short notice, there is often little time to gather all the necessary information.

Digital audit preparation using OSIANTO, with a particular focus on training

OSIANTO helps pharmaceutical companies to organise their training processes centrally and ensure that audit-relevant information is available at all times.

With this platform, you can:

  • Manage compulsory training courses digitally

  • Automatically assign training courses to staff

  • Conduct document training courses (e.g. SOPs)

  • Incorporate knowledge tests

  • Recording attendance and learning outcomes

  • Generate certificates automatically

  • Send reminders about upcoming training sessions

  • Create reports and analyses in just a few clicks

This results in centralised and transparent documentation of all training activities.

Training certificates available at any time

OSIANTO enables relevant information to be made available quickly. These include, for example:

  • Completed training courses
  • Training histories
  • Test results
  • Certificates
  • Document training courses
  • Open compulsory training courses
  • Skills levels of individual staff members

This reduces the effort involved in preparing for audits and ensures greater transparency.

Ensuring long-term compliance

Compliance is not a one-off task, but part of an ongoing process.

OSIANTO helps companies to:

  • Automating recurring training sessions

  • Keeping training records up to date

  • Meeting deadlines

  • To set out responsibilities transparently

  • Implementing regulatory requirements efficiently

This minimises the effort involved in preparing the documentation for the training programmes ahead of the next audit.

The digital training matrix for efficient audit preparation

With OSIANTO, your training matrix is automatically generated based on existing training data and continuously updated. Qualifications, completed training courses, outstanding compulsory training courses and training histories are centrally available at all times and can be quickly and transparently verified during audits.

Find out how OSIANTO’s digital training matrix helps you create transparency, reduce administrative burdens and efficiently meet regulatory requirements.

Digital training matrix for pharmaceutical companies

Which businesses is OSIANTO suitable for?

The OSIANTO platform is aimed at pharmaceutical companies, medical device manufacturers and their regulated service providers and suppliers.

There, OSIANTO provides support in particular for:

Qualified Person Responsible for Pharmacovigilance (QPPV) / Drug Safety Officer (DSO)

Department of Drug Safety/Pharmacovigilance

Quality Management (QM)

Quality Assurance (QA)

Compliance Officers

GMP Representative

HR and Training Managers

Production Manager

Frequently Asked Questions (FAQ):

How does OSIANTO help with audit preparation?

OSIANTO centrally records training courses, knowledge tests and document-based training, and provides clear reports and evidence at any time.

Can SOP training courses be documented using OSIANTO?

Yes – internal company documents can be made available digitally, verified and documented in a traceable manner using OSIANTO.

Is OSIANTO suitable for GMP-regulated companies?

Yes – OSIANTO was developed specifically for regulated organisations and supports the structured delivery and documentation of digital training processes.

See for yourself!

Discover how OSIANTO can help you organise audit preparation, training management and compliance efficiently.

Request a personalised demo instance now and get to know the platform and all its features. This will allow you to try out training courses, documentation and reports in a realistic environment and see how OSIANTO can best support your processes.

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