Protocol Manager utilizes Winchester’s ComPac GxP Application for compliance with 21 CFR Part 11.

Protocol Manager provides the following features:

  • Security – Protocol Manager utilizes the most comprehensive security model available to ensure that all information and data is viewed, read, edited, changed, and managed only by authorized personnel.
  • Audit Trail – Protocol Manager provides a human readable audit trail, at the field level, for each document in the system. Utilizing Winchester’s Snapshot technology, Protocol Manager tracks the original value of a field, the changed (new) value of the field and records the date, time and originator of the change.
  • Digital Signatures – By employing a PKI based digital certificate for identification and authentication, Protocol Manager can apply a digital signature to any electronic record in the system. Once applied, the digital signature will meet the criteria necessary for non-repudiation and identity challenges, and can be considered the legal equivalent of a handwritten signature.
  • Identity Confirmation – The Protocol Manager Authentication module, ComPac GxP, meets the guidelines set forth by the FDA for subsequent saving or signing of records in both a new session and in a continuous session.
  • Access Logging – Access to an application can be logged using the ComPac GxP tool set. When a user enters the database, the event is captured, the termination of that session is also captured and a log is written with the length of time of each session.
  • Access Control – One of the challenges in a regulated environment is to produce a 21 CFR part 11 audit trail of the access and permissions changes to an application. By utilizing the access control module (ComPac GxP), a full audit trail is written showing the access changes, the previous levels and/or roles and subsequent changed levels and/or roles.

HIPAA Compliance
Protocol Manager satisfies HIPAA regulations for patient privacy. The Clinical trial database identifies patients by reference number derived from an algorithm. During the patient recruitment process, demographic patient data is stored separate from clinical trial data.