As pharmaceutical and medical device companies start scaling cloud based compliant ( GxP/ SaMD) applications, there is a need to deploy a novel approach maximizing the benefits of flexibility and scaling cloud technologies provided by AWS. Automated Continuous Compliance- ACC solution leverages automation first approach to infrastructure qualification to help pharmaceutical and medical devices organizations achieve compliance on their cloud application faster with minimum manual tasks.

**Scope **

• Develop solution designed for automating Installation Qualification (IQ) of In-scope AWS services used in Customer's environment.

• Develop infrastructure qualification approach and plan.

• Customize the offering automation scripts to customer's compliance requirement. Execute the qualification scripts and prepare qualification reports (IQ).

• Testing of Customer’s qualification scripts (IQ).

• Enable Installation Qualification automation to qualify in scope AWS services used. Help Customer to complete Installation Qualification of their AWS infrastructure using this offering.

• Prepare qualification runbook to document the qualification process of AWS data Document, train and transition agreed upon knowledge to Customer’s chosen stakeholders.

Benefits of ACC

• Reduced cycle times for GxP readiness : Automated infrastructure qualification methodology and tools can get your GxP compliant AWS native application workloads faster to production.

• Continuous Compliance: Cloud-based automated IQ processes offer strong audit trails and traceability. It is possible to keep track of each step of the qualifying process versus any changes made to qualify Cloud Infrastructure.

• Cost savings: By reducing the need for human work, automation lowers the labor expenses related to the IQ process.

• Increased Efficiency: ACC allows for quicker qualification which allows for increased focus on innovation and business outcomes. Automation streamlines the IQ process and cuts down on manual labor, enabling businesses to finish installations and certifications faster. A quicker deployment of systems and a shorter time to market for products are two potential outcomes of this efficiency increase.

• Accuracy and Reliability: Automated IQ procedures reduce the possibility of human mistake, producing outcomes in qualification that are more accurate and dependable. It enhances the overall quality of the qualifying process and aids in lowering the likelihood of compliance problems.

• Scalability: Because cloud infrastructure is scalable, businesses may automate IQ procedures for several systems or installations at once. This scalability makes it possible to qualify many systems more quickly and effectively, which eases the strain on resources.