Table 2 CFR part 11 guidances and how our DCS accounts for each subsection

11.10 (a)

Validation of systems

Performance qualification document generated with FDA audit trail

11.10 (b)

Generation of accurate and complete digital and physical copies of records

Documents are stored as Microsoft Word documents and PDF files

11.10 (c)

Protection of records

SharePoint-managed groups and permissions with account passwords

11.10 (d)

Access limitations

SharePoint-managed groups and Microsoft account passwords

Individual documents can be further password protected if necessary

11.10 (e)

Creation of time-stamped audit trails

SharePoint tracks all changes to document versions

Adobe Sign tracks the review and approval process

These features combine to form a complete audit trail

11.10 (f)

Operational system checks

The workflow is managed by Power Automate which is effectively the operational system

Every run of the system can be examined at each process step and evaluated for completion and elapsed time

11.10 (g)

Authority checks

Access to the SharePoint library and its documents is managed by a SharePoint administrator who assigns user privileges

Adobe Sign requires pre-selected document reviewers to login and defines user privileges in accordance with their assigned roles

11.10 (h)

Device checks

UPMC login is required to access the local network on which SharePoint is hosted

Users must sign into their Microsoft account to access the SharePoint document library

11.10 (i)

Proof of qualifications

Employee training documents are available for and reviewed by all system users

11.10 (j)

Establishment of policies that hold signers responsible under their electronic signatures

E-signature disclaimer on the coversheet seen in Adobe Sign at the time of signature

11.10 (k1)

Control over distribution, access, and use

All process documents are stored in SharePoint under carefully assigned and controlled user permissions

11.10 (k2)

Revision and change control procedure and their audit trail

Documentation pertaining to this document control process will be kept under the same protocols it enforces

Document libraries include SharePoint versioning and Adobe Sign audit trails

11.50 (a)

Signed records must contain the signer’s printed name, date, and time of signature, and the meaning of the signature

All fields are present on the Adobe Sign Template

All informatization, minus the signature, is automatically generated at the time of signature

11.50 (b)

All information required in 11.50 (a) will be available to the reader in both digital and physical format

Signed document is exported to the SharePoint Live Documents library as a PDF file, which has the signatures and associated information on the coversheet

11.70

Signature/record linking

Managed and controlled by Adobe Sign which is a Part 11 compliant e-signature application