Certified Secure Software Development
At TEKenable we deliver secure software in accordance with ISO27001, ISO9001 and Software as a Medical Device standards ISO13485 and IEC62304
We provide Secure Software and Risk Consulting to help your C-Suite understand and Manage Cyber Risk
All the software that we develop is in compliance with ISO27001:2013 and resistant to the OWASP Top 10 attacks. We use automated penetration testing and static code inspection as part of DevSecOps and our solutions are often tested by third party security companies as part of our customer’s acceptance testing. We hold CISSP, CISM and CSSLP certifications as well as ISO9001, ISO27001, ISO13485, IEC62304 and Cyber Essentials Certifications as proof of our commitment to cyber security.
Secure Software Development
Security cannot be added to software after it has been built. At TEKenable we start with the end goal in mind – beginning with a clear understanding of the risks and needs of the software application and embedding security at each stage – from architecture, design, implementation and the testing process. We call this our Secure Software Development Life Cycle (SSDLC). The image below shows the steps.
Risk and Cyber Security Consulting
We provide advice and guidance on a wide range of cyber security topics.
Our cyber security team are accredited CISSP (Certified Information Systems Security Professionals), with qualifications in CISM (Certified Information Security Management) and CSSLP (Certified Secure Software Lifecycle Professionals).
We also have specialist Azure Architects, DevSecOps Engineers and – not to mention over three decades of practical real world experience delivering enterprise solutions.
Medical Device Software
We provide healthcare software development services for creating medical apps classified as Software as a Medical Device (SaMD) under the medical device regulations. Our team brings a wealth of experience in using the Microsoft technology stack and other technologies. We use the IEC 62304 software development process, helping to deliver software applications conforming to ISO 13485 regulations. Our subsidiary Greenfinch Technology is an Irish software development company that specialises in SaMD projects. We work with medical companies in Ireland, the UK and as far away as America.
We have the expertise to make your business compliant to FDA-CFR regulations
By introducing the 21 CFR Part 11 rule, the FDA has essentially enabled the FDA regulated industries to streamline business processes, reduce turnaround time and costs, all by establishing standard criteria for the use of electronic records and signatures. This rule helps businesses manage records and other content electronically, significantly decreasing the risk of human errors, reducing operational costs and minimizing time-to-market for pharmaceutical products.
TEKenable has experience of delivering validated systems for Clinical Trials and our staff additionally have experience of delivering system supporting:
- Stability Trials;
- Adverse Event (pre and post market) Reporting;
- Regulatory License Submission and
- Clinical Trials.
FDA 21 CFR Part 11
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Title 21 CFR is related to regulations regarding Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.
Our Approach
Electronic records must be maintained under described regulations to satisfy an FDA audit. Under 21 CFR part 11, if a system is defined as “closed” then following points must be considered during software development:
- System must be validated to ensure accuracy, reliability, consistent intended performance and ability to discern invalid or altered records;
- Record must be stored in such a way that they can be inspected, viewed or copied by FDA in both human readable and electronic form;
- Electronic records must be maintained for as long as the paper records that they replace;
- Secure, time stamped, along with time zone reference audit trails must independently record operator activities;
- Authorized individuals must have access to use, sign or alter existing record.
If a system is defined as “open” (email records, internet-based apps, etc) then following items should be considered:
- Document/record encryption maybe necessary to maintain confidentiality;
- Digital signature standards may be used to ensure record authenticity and integrity.
As a Secure Software Development company, TEKenable fully understands Part 11 of CFR and is able to provide clients with the essential tools required to meet the standards of FDA regulations.
Why choose TEKenable as
your Digital Transformation Partner?
Proven Track Record of Delivery into Enterprise Customers
and many more…
Over 150 Experienced Experts in Cloud and Low Code Platforms
Guaranteed a High Standard of In-House Expertise
Proven Track Record of Delivery into Enterprise Customers
Over 150 Experienced Experts in Cloud and Low Code Platforms
Guaranteed a High Standard of In-House Expertise
Trusted Microsoft and Salesforce Partner with over
20 years experience in software solution delivery.
Customer Success Stories
