GxP Direct
Our SAS-Based Tool For building and protecting your file system.
Securing SAS customers' data and analysis while maintaining stringent GxP standards
Plan out your entire file-folder hierarchy and access rights.
Allow for project, study, and individual analysis-level granular access rights.
Protect the study blind for randomized clinical trials
Uses SAS and Active Directory
The GxPD™ software provides access rights controls to clinical trial data and analysis deliverables stored on an accessible Windows server.
This allows biometrics teams to satisfy corporate retention policies, and aggregate and work securely with both unblinded and blinded clinical trial data.
The software includes:
- SAS-based software to create directory structure and change access rights.
- SAS-based relational database containing audit trail of changes to access rights.
- Installation documentation includes System Design Specification and IQ/OQ test case/report
Facilitating your clinical analysis
Modular Informatics’ GxP Direct™ (GxPD) brings your teams together with secure and structured framework
GxPD™ administers control access to projects, protocols, publications, and other work products to ease team collaboration.
Files and access-rights audit trail are mirrored to off-site Immutable S3 GxP Object Storage.
This helps satisfy corporate retention policies and can be incorporated into disaster planning.
- Allows teams granular control over access rights.
- This can be used e.g. to help maintain the study blind.
- Maintains a hierarchal working folder structure
- Organize SAS data, work, documentation, and deliverable packages.
- Allows teams to lock completed deliverable packages and create package snapshots.
- Maintains an access rights database.
The verification tool can check that access rights of files and folders match the expected results from the database.
Built using BASE SAS 9.4 and Microsoft Windows Server Technologies.
No other external software dependencies.
More Details for GxPD software:
What Problem does GxP Direct™ Solve?
“What Could Go Wrong?”
On modern computer systems, users with administrative rights can:
- Inadvertently delete files/ folders
- Alter the access rights of files/ folders
- Alter user access rights to files/ folders
If a file is inadvertently deleted from a final database package, how would you know?
GxPD™ is backed by Immutable Data Storage Which Means:
- By Policy, Data/Deliverables cannot be deleted by a single user
- Updates may be made, but all previous versions are accessible.
Files/folders may be verified and if necessary restored from the object storage
GxPD™ Verification Tool performs system integrity checks:
- Folder integrity: compare folder access rights against the GxPD™ database to ensure only the assigned users have the appropriate level of access to each folder. Deviation reports report on any specific integrity deviations.
- Snapshot integrity: check that package “snapshots” match the version stored in the Immutable Object Storage. E.g. if a file in a package is inadvertently deleted it should be detected and reported as a deviation.
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