PlantOPS provides integrated digital manufacturing software and services for regulated life‑science manufacturers, replacing paper records with electronic batch records, electronic signatures, and MES platforms such as POMS, POMSnet, Syncade, and PharmaSuite.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated life‑science manufacturers often rely on paper records, spreadsheets, and disparate legacy systems, which makes it difficult to maintain cGMP and 21 CFR Part 11 compliance, ensure data integrity, and achieve efficient batch documentation and equipment tracking.
Solution
PlantOPS delivers integrated digital manufacturing software and services that replace manual record‑keeping with electronic batch records, electronic signatures, and MES platforms such as POMS, POMSnet, Syncade, and PharmaSuite. The company provides end‑to‑end implementation, system integration, and hands‑on training to ensure that the solutions are correctly configured, validated, and aligned with regulatory requirements. By centralizing manufacturing execution, equipment efficiency monitoring, and material genealogy, PlantOPS enables real‑time data capture, automated workflow enforcement, and secure, audit‑ready documentation. Ongoing support and flexible collaboration models help clients sustain compliant operations while scaling their digital manufacturing footprint.
Target Audience
Primary customers are pharmaceutical, biotech, cell‑and‑gene therapy, biosimilar, and regulated consumer‑product manufacturers that need compliant MES and electronic record solutions.
Features
- Electronic Batch Records (EBR) with 21 CFR Part 11‑compliant electronic signatures and audit trails
- Integration with leading MES platforms (POMS, POMSnet, Syncade, PharmaSuite) and ERP systems for seamless data flow
- Equipment tracking and efficiency dashboards that monitor genealogy, maintenance, and utilization
- Configurable electronic work instructions and recipe authoring to enforce standardized processes
- Hands‑on implementation training and validation support to achieve cGMP compliance
- Scalable, web‑based architecture supporting real‑time data capture, review‑by‑exception, and exception handling
- Middleware (PlantOPS Interfacer) for bi‑directional communication with laboratory instruments and LIMS/ELN systems