Information Security Management and data protection in Pharma industry – B3S Pharma


Due to the increasing threats of cybercrime in digitized infrastructures, the topics

  • Data Protection,
  • Risk Management and
  • Information Security

are of high importance in the Pharma industry for the provision of the best possible service in the digitized world of

  • Patient Safety
  • Product quality and
  • Data Integrity

and the development and implementation of an adequate level of protection.

The introduction of an information security management system is necessary for an efficient and sustainable with all legislative requirements related to data protection and IT security.

Standard procedures for an overall compliance are as follows:

  • to data protection according to GDPR
  • the ISO 27001 for establishment and implementation of an ISMS and/or
  • of the BSI standard (IT-Grundschutz) as a systematic procedure to identify and implement necessary security measures.

For Pharma companies, which are considered KRITIS providers according to the IT Security Law, the implementation of the B3S Pharma Standard, which has been submitted to the BSI and approved by the Federal Professional Associations of the Pharmaceutical Industry, is obligatory.

The industry-specific security standard B3S Pharma focuses on

  • Development and implementation of an Information Security Management System (ISMS)
  • Development of an IT Risk Management System and
  • Action and process plans in case of failures and crisis situations (BCM).

QSEC® – the integrated management system for pharma industry

The integrated management system QSEC enables the implementation and operation of

  • Data Protection Management-
  • Information Security Management-
  • Risk Management- and
  • BIA/BCM-

processes as an integrated and methodical approach.

Additional benefits: The requirements of many other standards, such as ISO 9001, ISO 20000, ISO 14001, can also be managed efficiently and sustainably within QSEC.

Get to know QSEC and get your personal impression of the possibilities within QSEC.


References & case studies


QSEC Online-Demo