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.
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.
Software changes
Reign Factory is in beta. For eligible, well-specified work, it implements and tests the change and opens a merge request in the organization’s existing review process. The organization’s checks, reviewers and approval policy determine what reaches production.
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.
Assurance evidence
Reign Assurance is in co-design development. It is being designed to connect an agreed scope and outcome to requirements, checks, results, exceptions, recorded decisions and coverage. Reign Assurance does not perform system validation. It does not certify, does not attest, does not issue an audit opinion and does not provide independent assurance, in any tense.
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 and 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. iTmethods makes no compliance, certification or accreditation claim under any framework.
Choose the deployment model that fits the system and data scope.
Reign runs as a dedicated single-tenant deployment in infrastructure iTmethods operates or in the customer’s AWS or Azure account. Air-gapped and sovereign deployment are supported. There is no multi-tenant or shared option at any tier. 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.