How can GxP compliance be simplified?

MeetingGxP complianceis not just about achieving a compliance goal.

It is also about risk mitigation and protecting the safety and well-being of patients.

Here is an Executive Summary of Appian's approach to GxP compliance:

We believe:

• • GxP compliance is a state, not a certification
  • Achieving compliance with GxP standards depends on people, procedures and process
  • GxP compliance is ultimately the responsibility of the drug/biologic/device sponsors (i.e. our customer - the drug, biologic and device companies)

And soÖ

• • Appian and AWS establish and follow best practices with regards to People, Procedures, and Process, that permit our customers to achieve a state of GxP compliance
  • Appian collaborates with our customers' Quality Assurance & Compliance teams, as well as with qualified third party GxP consultants, to achieve a state of GxP compliance for our customers
  • Appian is PaaS, and our Platform design and build follows strict SDLC and software quality assurance standards with extensive regression testing
  • The Applications built on top of the Platform then need to meet GxP validation standards

Before we review the elements of Appian's core architecture that support GxP, it is important to note how configuring applications in Appian is different from efforts in other software approaches.

Applications in Appian are developed using graphical business process models instead of writing computer code. These models serve as both the documentation of the application, as well as the executable artifact that performs the application's functions. Plus, the Platform uses anagile development methodology that takes advantage ofshort development cycles and constant customer and subject expert feedback ensures the right solution is delivered as quickly as possible.

Because Appian solutions are created with graphical models and not hand-written computer code, it is easy to share mid-stage development with business users. This evolutionary approach creates transparency in the development process and facilitates a constant feedback loop for continuous requirements validation. This results in applications that are generally delivered with higher confidence in a shorter time period and at a lower cost.

Appian is dedicated to configuring software solutions for the Life Science industry that satisfy Title 21 CFR Part 11 requirements, as well as GxP (i.e., GMP, GCP, GLP, and GAMP). We recognize our Life Science clients must follow good practices (GxP) to ensure their manufacturing processes, clinical trials, technology transfer/scale ups, and post-marketing surveillance activities meet very specific compliance and quality requirements. Appian's core architecture includes many features that assist in validation and ensuring compliance to relevant international quality standards and best practices.

For more detailed explanation of how Appian and AWS support GxP please see this whitepaper, as well as the recently published AWS Blog and White Paper.

Evi Cohen

Practice Lead, Life Sciences

Appian