Digital Health & Pharmaceuticals
Digital technologies are integral to daily life and there is immense scope for use of digital health solutions and automation. While these new fields of application bring benefit they are also bringing new challenges, in 2 domains:
- Cyber security: To protect the privacy and integrity of patient and other criticial data and the security of critical connected devices to avoid them being hacked or remote controlled.
- Functional Safety: Operational safety of automated devices such as e.g. ICUs, insulin pumps, pace makers, and the application of neural networks in controlling those devices or as support for the medical teams in image scan (e.g. cancer detection) or similar areas regarding their safe and reliable operation
CertX may help you in evaluating and mitigation those risk in all those areas.
Applications and medical equipments need to take care of the security of sensitive data and critical equipment like ICUs must not be hacked, remote controlled or shut down.
Ensuring and maintaining security and privacy in the pharmaceutical sector with specific or tailor made pharmaceuticals is probably one of the most important and but also most challenging subjects.
In order to get your company processes and setup ready to ensure compliance to the latest regulation Codema has developped a set of protocols ensureing your processes and used tools and service provider are prepared and maintained.
Standardising criteria of evaluation is a key element in the CODEMA PHARMA approach (more details at the links below).
- Blockchain technologies. Codema RP 2100
- Cloud services – Infrastructure as a service. Codema RP 2200/1
- Cloud services – Platform as a service. Codema RP 2200/2
- Cloud services – Software as a service. Codema RP 2200/3
We offer the for each protocol 2 different levels of evaluation:
- Gap Analysis: This is based on a self assessment being evaluated by our experts incl. a remote pre-audit. You will receive a report defining areas of compliance and non-complianecs (if any), as well as recommendations for improvements.
- Certificate: Our experts will run through the protocol in an audit (on-site or remote) to evaluate independently the implementation of the protocols in your managements system and processes.
A gap analysis can be done standalone. For a certificate stage 1 and 2 as defined above are required. More info on the generic management system certification process please see here and more details on the the Codema Protocols can be found here.
In case of further details or a quote requested, please contact us via the project request form below. For a quotation we would need the number of employees and number of different sites, which you may specifiy in the request description.
Your project request – contact us
Please fill the template below for any request you may have. Leave fields empty in case you are not sure or cannot provide the information. We will be happy to get back to you and find out the necessary info in a call or videoconference.
Training & Person Certification
CertX provides a dedicated person certification program at different level of expertise for responsibilities for safety management related to IEC 62443 (operational cyber security) or ISO 13845 (QMS for medical devices)
We also offer in combination with Medidee introductory and overview trainings
CertX experts can also provide customized and in-house training to meet the your needs for qualifying your staff.
See more details about our qualification scheme at our training & person certification process page