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For the QA, IT and validation teams who do the work
We partner with pharmaceutical, biopharmaceutical, personal care and other regulated companies at every stage, from organizations building their first assurance program to established quality functions moving from CSV to CSA or bringing AI into GxP processes.
Where you might be
- An audit finding, a new system or a first inspection on the horizon
- No policy, no system inventory, and templates borrowed from a previous vendor
- Spreadsheets, cloud tools and AI assistants nobody has assessed
How Attestra helps
- Policy and governance that settle scope, accountability and risk philosophy
- A GxP system inventory with impact assessments
- A simple risk method, then SOPs and templates that reflect your own decisions
- A pilot on real systems before rollout, with training built from it
Where you might be
- Procedures that script every step, whatever the risk
- Long validation cycles that slow down routine system changes
- Teams used to scripting who need permission, and practice, to apply judgment
How Attestra helps
- SOPs, templates, change control and training redesigned around risk-based thinking
- Clear mapping from each risk level to its assurance activities
- Examples drawn from your own systems, so the new approach sticks
Where you might be
- Teams asking "is this AI tool GxP?" with no agreed way to answer
- AI in use that nobody formally approved
- Vendors updating models under workflows you depend on
How Attestra helps
- An inventory of AI use, not just AI tools
- Intended-use decisions and risk classification for each use
- Testing, audit trail, human review and governance where a use is in scope
See yourself here?
Tell us where your team is. We'll suggest where to start.