On Wednesday June 17th Compliant Cloud held our inaugural virtual conference “How to Deliver Compliance in these Challenging Times”. The free conference featured presentations from an excellent line-up of speakers, including industry guest speakers Nuala Calnan and Karl Curtis, and was an engaging half day filled to the brim with fresh insights and industry knowledge. Whether you were there or not, here are six key takeaways from the virtual conference.
Agile is here to stay
You’ve probably had at least some contact with the phrase “Agile” and its fluid, flexibility-based approach to project management. An alternative to the sequential, step-by-step Waterfall method, Agile methodology involves solutions evolving throughout the process, through consistent collaboration among cross-functional teams.
As well as the above, what we learned from Operations Lead Andrius Ramanauskas’ presentation “Agile in a Regulated World” is that Agile is not just a buzzword in the industry, it is here to stay, and – if implemented correctly – can lead to deploying innovative products more quickly while remaining compliant.
An e-QMS can improve the efficiency of an organisation
With an e-QMS (electronic Quality Management System) there is less room for human error, compliance can be built into the workflow, and you can improve the efficiency and stability of your processes by providing a means for standardisation and continuous improvement. As stated by Compliance Lead Mag Corduff, having stability within your QMS is more important now than ever; regulators have mentioned that expectation is that there should be no delay when documenting occurrence of deviations / nonconformances as per your defined process, and where applicable any nonconformances that have an impact on product quality or patient safety must still be actioned in a timely manner.
Software as a service (SaaS) has become an essential deployment model
CEO Oisín Curran delivered the keynote speech of the virtual conference, “How to Deliver Compliance in these Challenging Times”, and it was full of golden nuggets of information. Our key takeaway is that Software as a Service, or SaaS, has become less of a possibility and more of a probability – many software vendors have SaaS as their only delivery model. We also learned that the use of XaaS without the possibility to audit or ensure that Annex 11 is fulfilled should not be accepted.
A robust supply chain is everything
Industry guest speaker Nuala Calnan, Founder and Principal of BioPharm Excel, emphasised the impact of a robust supply chain during unprecedented circumstances such as the COVID-19 pandemic. The COVID-19 pandemic was something the marketplace didn’t see coming, and organisations with a flexible culture of continuous improvement were more prepared for the fallout of the pandemic and were much more resilient in managing workflow and maintaining progress in this environment. There has also been a huge amount of collaboration and innovation in terms of fast-tracking more new products and therapies.
When it comes to Validated SaaS, it’s all about the vendor
When looking for SaaS and validated SaaS, the auditing and selection of the vendor is key to success. You can outsource, but you cannot outsource your responsibility to meet compliance, as CTO Fionnán Friel covered in his presentation “SaaS vs. On-Premise – what is important to get right”. The vendor audit needs to confirm vendor capabilities in all phases of the system, from concept to retirement. The better the vendor the more you can leverage, cut costs and save time. In the Operations phase you need to continuously monitor the system and your relationship with the vendor and make sure any compliance deliverable that rests with the vendor is being executed as required.
Infrastructure is just as important as the application itself
Vice President of EIS Inc. Karl Curtis was an industry guest speaker, delivering a presentation on “Say Goodbye to Paper: Increase compliance through OpsTrakker’s mobile form and logbook app”, in which he explained the need to replace paper with electronic solutions, provided a demo of the OpsTrakker app, and predicted future trends in the industry.
A key takeaway from Karl’s presentation was that, when creating and implementing applications, the infrastructure the application rests on is vital and must be qualified. When both your application and the infrastructure it rests on are qualified, what you end up with is what Karl referred to as a “Fully Compliant System”.