SOP MANAGEMENT FOR PHARMA
Purpose-built SOP & compliance software for GMP and US-FDA regulated pharma companies.
AFFORDABLE SOP MANAGEMENT SOFTWARE FOR LIFE SCIENCES
SOP Management System is an intelligent, automated platform specifically engineered for the Life Sciences industry — bridging the gap between strict regulatory demands and daily operational efficiency. Move from paper-based processes to a fully validated digital compliance environment
SOP Management System
SOP Management System is an intelligent, automated Standard Operating Procedure (SOP) management system specifically engineered for the Life Sciences industry. We bridge the gap between strict regulatory demands and daily operational efficiency, allowing you to move from paper-based chaos to a fully validated digital environment.
US-FDA & GMP Compliance
Ensure every document, revision, and SOP aligns with current Good Manufacturing Practices (cGMP). Our system provides a secure framework that meets FDA 21 CFR Part 11 requirements, offering digital security, data integrity (ALCOA+), and seamless compliance for drug development, manufacturing, and laboratory environments.
Eliminate Non-Compliance and Risks
Stop accidental unauthorized changes. SOP Management System ensures that only authorized personnel can create or edit documents, automatically alerting personnel of pending training or SOP changes. The system prevents the use of obsolete procedures and ensures logical workflow, significantly reducing human errors and regulatory risk.
21 CFR Part 11 Compliant Electronic Signatures
Eliminate the risk of lost paper records. SOP Management System supports secure electronic records and legally binding electronic signatures, ensuring that all electronic data is trustworthy, reliable, and equivalent to paper records.
Easy Audit Trails (Gapless Traceability)
Be always inspection-ready. Our system captures every action—creation, modification, maintenance, archiving, and retrieval—in a secure, time-stamped, and non-modifiable audit trail. Easily retrieve document history, review user activity, and demonstrate full compliance during FDA or external audits.
Timely Alerts
Management of SOPs across plants, departments, labs, becomes easier with timely alerts for intervention. It eliminates unintentional delays.
Scalable for Small and Medium Companies
High-grade, complex compliance tools are no longer reserved for Big Pharma. Our system is designed for SMBs, providing an intuitive, user-friendly interface that requires minimal training. Affordable, easy to deploy, it allows small companies to implement robust Quality Management Systems (QMS) without complex IT infrastructure.
