A New Validation Offering for Regulated Customers
Regulated customers using the Platform for Science span across a number of industries, including Pharmaceutical, AgBio, and Academia. Organizations range in size from small start-ups to Fortune 500 companies, but they all need to do the same work to ensure the accuracy of their software platform. Customers use our validation offerings to deploy the Platform for Science on-premises and in the cloud.
Beginning in 2018, customers will be able to take advantage of a new offering to implement a validated solution with reduced cost, improved implementation time, and a dedicated focus on regulatory compliance.
Qualified Platform for Science (PFS) Release
The Qualified PFS Release is an internally qualified version which complements our current offerings as part of a validated solution for regulated customers. Using the Qualified PFS Release streamlines the implementation of a validated system, minimizing costs and reducing project timelines. Most important, it provides documented evidence that the system will accurately and reliably perform the functions intended for use. The Qualified PFS Release reduces implementation timelines by removing the requirement for OQ after install.
The following are included in the offering:
- Annual subscription provides customers with up to two qualified releases per year
- OQ with documentation
- Access to Core’s validation document package
- Core-led IQ on up to two environments per Qualified PFS Release implementation
Use of the Qualified PFS Release in Regulated Environments
The Qualified PFS Release enables customers to develop a 21 CFR Part 11 compliant solution by providing proof of compliance with regulatory requirements. Some of the features verified in the Qualified PFS Release offering include:
- Limiting system access to authorized individuals
- Access level security for projects and data
- Password restrictions and controls to ensure uniqueness, complexity, and periodic revision
- Audit trail functionality
- Use of operational system checks to enforce a permitted sequence of actions
- Use of authority checks to control data access
- Use of authority checks to control user role regarding authorship, review, and approval of data
- Electronic signature management
Documentation of compliance-specific functionality includes a 21 CFR Part 11 specific Functional Requirements Specification (FRS) and traceability matrix. Overall system functionality is documented within the Platform for Science FRS and OQ traceability matrix, and is also verified in the Qualified PFS Release.
Qualified PFS Release Package and Deliverables
The Qualified PFS Release package includes the following:
- Platform for Science FRS and OQ Traceability Matrix
- 21 CFR Part 11 FRS and OQ Traceability Matrix
- Validation Project Plan developed and approved by validation and quality teams
- Testing Protocols including executed IQ and OQ
- Validation Summary Report and Qualified PFS Release Certificate
- Core Validation document package for use in additional validation activities
- Validation Project Plan template
- Validation Summary Report template
- IQ and OQ protocol
Complete Validated Solution
Customers can purchase additional validation offerings which complement the Qualified PFS Release option to provide a fully validated solution.
- Deploy the Qualified PFS Release using our validated cloud offering to achieve a validated solution while taking advantage of the low IT overhead and on-demand scalability that the AWS cloud infrastructure provides.
- PQ protocol draft and execution services to include customer specific user requirements in the final validation package.
- Document full validated solution within the Core Validation Package.
Based on historical customer data, we estimate the Qualified PFS Release will cut implementation timelines by four weeks, with a cost savings of up to 50%.
For more information about moving your GxP lab to the cloud, read our blog: Regulated Labs Can Use the Platform for Science on a Validated Cloud Infrastructure.