"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Storage of Pharmaceutical products

Validation of software for QMS process

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.

Course description:

ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process.

Knowing how to combine ISO 13485:2016 QMS software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.

Course outline:

  • Introduction
  • Validation process
    • Inventory
    • Selection
    • Effort of validation
    • Additional criteria for validation
  • Design qualification
  • IQ, OQ, PQ
  • Special cases: Excel, data backup-restore…

Learning objectives:

  • Learn the concepts of QMS software validation,
  • Learn how to assess risks related to QMS software,
  • Learn how to apply IQ, OQ and PQ to QMS software.

Who should attend:

People working for medical devices or in vitro diagnosis manufacturers:

  • Quality Assurance and Regulatory Affairs Managers
  • Software Project Managers
  • Software Development, Risk Management, and Test Engineers



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Course facts

Course no:
Medical Device

QS region:
Global (ISO 13485)

Cyrille Michaud
Cyrille Michaud

Date, location and venue:

9 October, Copenhagen, Denmark
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Register by 28 Aug - Save 750 DKK (€ 100)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Kødbyen (800m)
» Scandic Copenhagen (800m)

This course is also offered in-house.
Click here for more info and inquiry form.

1 day
8.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
Early bird up to 28 August: 7 080 DKK (€ 950)
From 29 August: 7 830 DKK (€ 1050)
incl. course material (pdf), lunch and refreshments

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.