CtrlPoint
Quality & Compliance

Compliance Is Not
An Add-On.

Designed to support compliant electronic records and signatures. Built around attributable, legible, contemporaneous, original, and accurate records.

Foundations

Engineered into the platform.

Capability
Unique User Identity

Every user, every action, every signature - attributable to a single person.

Capability
Role-Based Access

Permissions scoped to roles, sites, and record types.

Capability
Electronic Signatures

Signatures with meaning, user, date, and time - preserved with the record.

Capability
Immutable Audit Trail

Every write sequenced and preserved; every change explainable.

Capability
Version-Controlled MBRs

Author, review, approve - with reason-for-change and controlled release.

Capability
Reason-For-Change

Every correction and change captured with justification.

Capability
Review By Exception

QA guided to entries requiring judgement; complete record remains available.

Capability
Batch Disposition

Release, rejection, and hold decisions follow defined checks and signatures.

Capability
Search & Retrieval

Every record retrievable in its original structure and context.

Capability
Secure Retention

Long-term retention with locked PDF export where required.

Capability
Validation Support

Documentation, test artifacts, and structured configuration to support customer validation.

Capability
Data Integrity

Aligned with ALCOA+ data integrity principles across the record lifecycle.

Standards
21 CFRPart 11
EUAnnex 11
GAMP5
ALCOA+Data Integrity
ISA-95Aligned

Configuration and validation remain controlled within each customer implementation. CtrlPoint does not assert automatic regulatory compliance on behalf of customers.

Next

Review our compliance foundations with your QA team

A working session with our quality and validation engineers.