Document Management
A central place for the SOPs your operation runs on — FDA CGMP, drug gases, device gases, and food gases, plus shielding gases… and more — organized, tracked, and easy to find.
Specialty gas operations run on Standard Operating Procedures — and those SOPs need to be current, organized, and easy to find when an auditor (or your own team) needs them. AsteRisk's Document Management system houses SOPs across four core areas:
CGMP
Current Good Manufacturing Practice procedures for specialty and medical gas production, kept current with FDA regulatory updates (21 CFR Part 213).
Shielding Gas
SOPs for shielding gas products and operations.
Devices
Procedures covering medical device requirements.
Food Gases
SOPs for food-grade gas production and handling.
Version-controlled, not static PDFs
Manuals are organized into structured volumes — covering everything from core procedures to supporting resources like Certificates of Analysis — and revised as regulations change. AsteRisk tracks and distributes each version (for example, updating a Medical Gas Manual from v7.2 to v7.3 as 21 CFR Part 213 requirements evolve), so your team and your auditors are always working from the current document, not an outdated copy sitting in someone's inbox.
Training built in
Document Management doesn't just store your SOPs — it's also where AsteRisk keeps CGMP training modules and quizzes tied to those procedures, so your team can train against the same documents they're expected to follow.
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