Take control of compliance early
Delivering biotech products to market requires compliance in many forms: safety; ethical; privacy; information security; physical security; handling human samples.
Forward thinking scientific leaders put the policies and processes in place as early as possible to start realising control and efficiency benefits immediately, as well as avoiding time consuming and costly projects to change procedures in the future. Being ready to handle human samples with proven HTA, GDPR or HIPAA procedures when human samples or data are available will keep research on track, avoid unexpected costs and enhance your reputation with clinical partners.
The most complex requirements involve handling handling samples and data about humans; including control of physical samples, privacy and security of any associated data; and how you process/share these data. This is especially true if you are developing your own software to handle human data including the need to put in controls for your software development lifecycle (SDLC) and integrating it with your laboratory-based systems.
Prismea were able to quickly assess our requirements in order to meet our regulatory obligations, provide a detailed action plan and were able to execute on this plan perfectly. The policies and procedures that Prismea created for us not only met our needs for software development under ISO15189, but also seamlessly linked into our existing Azure DevOps processes and QA systems.
UK testing lab
What Prismea does to make compliance easy
We start by reviewing your current policies and ways of working to provide a gap analysis and migration plan to meet your immediate compliance needs.
This provides confidence to you (and to auditors) that you are in control of your evolution to compliance.
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We write policies and procedures tailored to your needs that meet compliance requirements, that integrate with your current ways of working and are lightweight.
We integrate with current QA/technical processes and software to ensure that all new procedures are easy to use and fast to implement.
We work with your technical and quality colleagues to support new procedures by helping implement technical solutions and sharing knowledge/expertise.
- Build compliant cloud infrastructure
- Create an initial Risk Assessment
- Manage monthly meetings / annual reviews
We have written for, implemented and worked under:
- GDPR (EU)
- HIPAA (USA) including physical security
- ISO including 9001, 13485, 15189, 27xxx
- Human Tissue Act
Growth through compliance
Good procedures fit in with your ways of working and provide a vital, extra feedback on how well your team is working. Review of these data helps identify many aspects to continuously improve your workflow, makes you ready to handle human samples and always be audit ready.
Efficency benefits include identifying the differing working speeds to remove process bottlenecks; the type and frequency of problems that cause quality issues; and where extra data sharing can improve work. This also means that downstream teams benefit from structured recording of process deviations on incoming samples, and avoiding problems when processing them any associated troubleshooting.