If you have been following the life sciences space recently, you might have noticed some things that seemed highly unlikely only a few years ago: tech startups transforming into medical devices companies, e-cigarette companies caught up in a national scandal of black-market vapes and unknown long-term human effects, cannabis startups racing to enter markets that state governments are struggling to establish — all of this with very little "quality" history.
Traditionally, these highly regulated spaces were paper-based, meaning all Standard Operating Procedures (SOPs), work instructions, records, and many other processes had to be handled the same way they had been for many, many years. Multiple people signing off approvals, storage boxes full of archived documents, delays in finding relevant records, all contributed to a complete lack of visibility and efficiency.
This is not something new.
In 1997, the FDA established 21 CFR Part 11 that described the requirements companies need to meet in order to eliminate paper-based records in favor of electronic records and signatures. So, where are we today?
Many companies in recent history have been "born in the cloud," having little or no IT systems and personnel to support their aspirations of fast time-to-market and pivoting to new products and offerings.
Google's G Suite and Microsoft’s Office 365 have been key in enabling collaboration, accessibility, and efficiency; however, they are missing many key features mandated by the FDA. This creates a situation where at least one additional tool is needed to meet these FDA requirements, meaning users must learn another new tool, which isn’t ideal.
The worst part is that most of these FDA-specific products were developed in the ‘90s and can’t possibly deliver the experience users demand today. Why did Apple succeed in the enterprise? Because they delivered work tools that are as intuitive and simple as the tools we use at home. The same reasoning rings true with enterprise document and collaboration tools today.
But how can an organization ensure that they are both meeting their FDA compliance requirements and the needs of their users? Here are our Top Three Tips for Evaluating a Cloud Quality Management System (QMS) to address these issues:
So, your organization has adopted G Suite but your QMS software vendor only supports Microsoft Office or PDF formats? Will you purchase MS Office for everyone? How will people collaborate on those documents? How will you manage versions? What about document approvals?
Any QMS that you select in 2019 and beyond must have collaboration and document management capabilities baked in. This is not an optional component.
Does the tool you are evaluating have all of the features you need to meet the requirements of the FDA or any other regulatory body out of the box? If no, why not?
Many vendors require extensive customization via professional services to help get you up and running — a cost-intensive “can of worms” that will slow down your business and explode the cost of your solution.
Once you have selected a vendor with great collaboration and all the right features out of the box, the next question is whether or not they can support your ongoing software validation needs.
Validating every single release of an FDA-ready system can take weeks of working hours every time a change is made to your system. This can be an additional drain on time and resources that many do not account for.
Automated software validation removes the need for manual effort — think process automation for validation. Make sure your new system has at least the ability to integrate into an automated software validation tool and, ideally, built-in functionality.
As you research and evaluate vendors to deliver a Quality Management System within your organization there are many aspects to consider:
But the most important question for many is not technical but cultural and philosophical. Is the vendor someone who will partner with your organization today and into the future? To deliver the best possible technical solution? To commit to ongoing support and maintenance? To continue to work together for the best for both organizations?
If so, then fantastic — you have found a vendor and an associated solution that can serve you well, for both the short and the long term. If not, it’s a bad fit and time to walk away.
AODocs for Life Sciences is a Quality Management platform for organizations to confidently build their Quality Program and reduce the cost of Computer System Validation & Assurance (CSV&A) while accelerating time to deliver business solutions.
Do you prefer video? Watch the Introducing AODocs for Life Sciences webinar