On a good day, your software systems do exactly what you designed them to do (verification). On a great day, their design is also correct, complete, and auditable (validation).
Pharmaceutical and other Life Sciences companies can't afford to wait around for occasional great days they are required by law to meet Validation and Good Practice Standards (GxP) when building systems for Clinical Trials, Quality Assurance, Regulatory Information Management, Manufacturing, or Electronic Health Records.
Me? I've worked in Pharma for more than two decades. I've been fortunate to be a first-hand participant in transforming manual processes...to employing local electronic controls (PLCs)...to relying on computerized systems...to enlisting client server networks...and now in moving all of this to the Cloud.
Each transformation advances capabilities and enhances automation, but it also carries a heavy burden. Making sure nothing is missed while maintaining the highest level of integrity must happen across everything we all do. After all, doesn't it all have a potential impact on the well-being and lives of our patients?
Industry and the regulators have been performing a well choreographed dance for many years. But, it's only in the past decade or so that you can really see an important shift towards collaboration. For Life Sciences In the US, as well as across Europe and other jurisdictions, we are seeing industry and governments coming together and holding public conversations to enhance public safety and improve our collective knowledge. This is happening concurrently in medicine, genomics, devices, computerised systems, and big data.
Advancing Pharma capabilities across the board relies on a solid foundation that permits progress to occur within the confines of disciplined change to avoid harm. This is where the concept of "Validation" comes in.
The FDA defines Validation, pertaining to electronic systems, as "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." Such confirmation is achieved through:
- Planning the system requirements, in cooperation with subject matter experts.
- Verification and Testing to ensure identified requirements are met by the software.
- Traceability: mapping the requirements to the different elements of the implemented system.
- Configuration Management: Is the deployed system secured to the correct participants and consistently available? Is all data guarded against unauthorized access and changes, as well as recoverable in the event of a disaster?
When we relied on local systems PLCs connected to an MES, or one PC running a process validation and verification usually involved a packaged solution validated within the confines of a well defined "box." A software company built the system ten years ago, tested it, and got a formal stamp of approval so your work is done. The only problem with this approach? The system doesn't actually meet your current needs any longer; it doesn't connect to your enterprise systems, and is at least ten years behind on the technology. It cannot connect to other cloud based systems, and it in no way supports mobile capabilities.
Today, innovative Life Sciences companies have many compelling reasons to build modern applications that fit their businesses and are fit for purpose.
Imagine implementing a cutting-edge system to meet your organization's needs today and into the foreseeable future, without assuming all the headaches of validation from scratch.
An application platform in the Cloud will provide for a majority of the IQ (installation qualification) and PQ (performance qualification) requirements and allow you to concentrate on the OQ (operational qualifications) of the business solution itself.
Appian's cloud-based GxP solutions are solidly structured on the Amazon Web Services (AWS) architecture so you can have confidence in the availability, performance, security, and disaster recovery for Life Sciences applications. This announcement by Amazon provides more details on how AWS can fit into your GxP-compliant technology initiative.
Evi Cohen
Practice Lead, Life Sciences
Appian
