Set up a compliance framework
Turn on the regulatory standards your organization develops under, configure the data-integrity controls behind them, and apply each framework to the projects it governs.
This is the admin foundation for everything in the Compliance section: the regulatory standards your organization develops under, the data-integrity controls that make records trustworthy, and the act of applying both to the projects they govern. Configure it once, centrally, and every project inherits the same interpretation. For the concepts, see Compliance frameworks.
Enable the regulatory standards
The regulatory standards that apply to your work — the FDA, ISO, IEC, and EU frameworks — are enabled at the organization level so every project starts from the same definition.
Before you start Open Administration and go to Compliance frameworks. You'll need administrator access.
- Enable the regulatory standards that govern your work — see Frameworks for what each one covers.
- Configure each standard once, at the organization level, so its interpretation is defined in a single place.
Result A governed set of standards, defined once rather than reinterpreted by each team. See Compliance frameworks.
Configure the data-integrity controls
Behind the frameworks sit the data-integrity controls — the settings that let the platform prove records haven’t been altered.
- Configure the data-integrity controls, including the chain hashing that makes records tamper-evident in support of the ALCOA+ principles a regulator expects.
- Confirm these controls are active before controlled work begins — they underpin the trustworthiness of both the audit trail and electronic signatures.
Result Records are tamper-evident, so the audit trail and signatures rest on data that can be shown not to have changed.
Apply a framework to its projects
A standard configured at the organization level governs nothing until it’s attached to the projects it applies to.
- Attach each enabled standard to the projects it governs.
- Because the standard is inherited per project rather than redefined, every project under it is held to the same interpretation.
Result Each project is governed by exactly the standards that apply to it — consistently, without per-team drift.
Note Set the framework up before projects start producing controlled records. Because it shapes the controlled states, signatures, and checks throughout the product, configuring it after the fact means retrofitting controls onto work that was already done without them.
Where to go next
The user-facing side — what each framework requires and how readiness is proven — lives in the Compliance section. To configure how compliance is verified, see Compliance verification.