Auditing Services

Conduct fast and effective audits using a risk-based approach.

INTRODUCTION

We have many certified consultants with extensive expertise and experience, allowing us to provide a range of auditing services. We can assist in both planning and execution, whether you are preparing for an official inspection or need support in carrying out an internal audit. The results are reported in the format of your choice to suit your needs.

We are experts at managing post audit actions, such as providing support closing deviations or preparing and planning training programs and systems to better meet requirements.

We can perform individual audits/revisions or take a comprehensive view of your entire audit process across different areas.

Our capabilities include computerized systems and supplier evaluation of computerized systems, whether traditional or cloud-based solutions (SaaS – software as a service). We also audit the various elements of R&D, production, and distribution. We audit according to the standards, regulations, and guidelines governing pharmaceuticals and medical devices, such as:

  • ISO 13485
  • EU Medical Device Regulations
  • Quality System Regulation (QSR)
  • Medical Device Single Audit Program (MDSAP)
  • Good Automated Manufacturing Practice (GAMP)
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)

INTERNAL AUDITS

Do you want to ensure that your processes meet the quality standards of applicable regulations? Do you want to monitor a specific area in your organization?

We offer internal audits in several areas. These can be adapted to your specific requests with a focus on areas such as cloud solutions (SaaS (software as a service)) and data integrity. Additional examples:

  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Good Pharmacovigilance Practices (GVP)
  • ISO 13485
  • ISO 14001
  • EU Medical Device Regulation (MDR)
  • EU Medical Device Directives (MDD)

SUPPLIER AUDIT

We help you make sure your suppliers follow and adhere to applicable standards and regulations.

This includes suppliers of computerized systems, both traditional and cloud-based.

INSPECTION READINESS

Are you expecting, or preparing for, an inspection by a regulatory authority? We can help you to be well prepared for official inspections.

Using i.e. gap analysis, we help you to prepare a situation report and propose an action plan of the best ways to eliminate gaps and effectively prepare for inspection.

Training Packages

For inspection and internal audits we offer customized training packages that effectively prepare staff for the inspection or internal audit.

This may involve training in what happens during an official inspection or internal audit, with exercises and role play, or it could be in-depth education in the topics involved, such as Good Documentation Practices.

Read more about our training opportunities here »

CONNECT WITH
AN EXPERT

Ludvig Frigell
Ludvig FrigellClient Manager
Tel: +46 (0)72 566 87 95
Debora Ternström
Debora TernströmSenior Consultant
Tel: +46 (0)70 542 22 10
They identified crucial shortcomings during a supplier assessment. Their firm proposals made it easy to assess the prospects for future cooperation.
Ulf Stenfalk, Recipharm
The audit records were very thoroughly prepared, including all points reviewed, and were a great improvement compared to our previous internal audit process. The audits also included frequent references to MDSAP, which was very much appreciated.
QA Manager, Your Content Goes Here

KNOWLEDGE CENTER

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  • Branschorganisationen ISPE, har i juli 2022 släppt en ny upplaga av, Good Automated Manufacturing Practice, (GAMP), den globala riktlinjen för validering och [...]

  • PlantVision is selected as Oatly’s partner to implement Thermo Scientific™ SampleManager LIMS™ at Oatly, a global provider of plant-based products. The system will bring [...]

  • Med en stark historia inom Life Science, tillsammans med en modern mix av innovation och etablerad bransch med stora nätverk, är Uppsala ett [...]

  • Vad behöver jag som vårdgivare tänka på? MDR- och IVDR-support för att möta de nya regelverken och förordningarna Den [...]

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