Keep changes to regulated systems attributable and reviewable.
Reign connects engineering work to records that quality, privacy and audit teams can review. The scope identifies the systems and data involved, the required access and approvals, and the records created by the products used.
Give reviewers a record they can follow.
Software changes
Reign Factory is available today. For eligible, well-specified work, it implements and tests the change and opens a pull request in the organization’s existing review process. The organization’s checks, reviewers and approval policy determine what reaches production.
Reign Factory →Governed AI traffic
Reign Gateway is available today. It creates an evidence record for each AI call sent through it, showing the caller, route, policy decision, destination, outcome, time and cost, subject to approved capture settings.
Reign Gateway →Operated engineering platforms
Reign Ops is available today. iTmethods assumes the agreed operating responsibilities for the engineering tools and open source services in scope. The operating record identifies the changes made under that service and the people involved.
Reign Ops →Record the systems, data and decisions involved.
Organization’s quality function
Identifies the systems in scope, sets acceptance criteria, approves the validation approach and determines whether the system is validated.
Organization’s privacy and data-protection functions
Determine the data categories, lawful basis, permitted locations, access requirements and retention rules that apply.
iTmethods
Operates or delivers the agreed engineering work and creates the applicable operating or evidence records. The deployment and operating plan records the selected environment, access, data handling, retention and approval roles.
Use the evidence within your quality system.
21 CFR Part 11
Part 11 provides requirements for electronic records and electronic signatures used for regulated FDA activities. The organization’s quality and legal functions determine whether it applies and how a system is validated.
GMP Annex 11 and draft Annex 22
The current Annex 11 addresses computerized systems used in GMP activities. A revised Annex 11 and a new Annex 22 covering AI in pharmaceutical manufacturing were published for consultation on 7 July 2025; the consultation closed on 7 October 2025.
As of 27 October 2026, the European Commission's EudraLex Volume 4 page still lists Annex 11 as the January 2011 revision and shows no Annex 22, so the texts remain drafts unless the European Commission publishes an adopted version.
These texts provide context for the records and responsibilities described here. The organization’s quality, privacy, compliance and legal functions determine applicability, validation and the conclusions supported by the evidence. Beyond SOC 2 Type II for Reign Ops, no other certification or accreditation is claimed.
Choose the deployment model that fits the system and data scope.
The deployment and operating plan records the environment, access, data handling, retention and approval roles that quality and privacy teams review. The Deployment page explains where applications, data and records sit and how administrative access and operating responsibility are recorded.
Discuss one system or engineering workflow in scope.
Let’s start with the system, the data involved, the approvals required and the evidence your reviewers need.