Inspection readiness depends on folders
SOPs in Word folders, training records in Excel, deviations on paper. Before every inspection the hunt begins for the current revision and the missing signature.
Quality management moduleControl SOPs with electronic signatures, prove training, keep lab equipment maintenance and calibration on schedule and take deviations through to CAPA. Project costs, sponsor contracts, NDAs and contacts sit in the same suite, for startups and GMP manufacturers alike.
Four typical bottlenecks and the module that fits each one.
SOPs in Word folders, training records in Excel, deviations on paper. Before every inspection the hunt begins for the current revision and the missing signature.
Quality management moduleInternal effort, expensive CRO hours and non-staff costs scatter across spreadsheets and people. By quarter-end the overview is gone.
Project management moduleSponsor contracts, non-disclosure agreements, service agreements with CROs, each with its own deadline. Signatures drag on for weeks.
Contract & digital signatureSponsors, investors, CROs and contract physicians in inboxes and spreadsheets. Who spoke to whom last?
CRM moduleControl SOPs from authoring to QA release, distribute them to the right recipient groups for training, and take deviations through to CAPA with an effectiveness check. Electronic signatures and the audit trail support the requirements of 21 CFR Part 11 and EU GMP Annex 11.
Record balances, pipettes, biosafety cabinets, incubators and cold rooms with their maintenance and calibration intervals. vemix creates a work order for every due date, reminds the assignee and escalates when something is overdue. The evidence is created as a QM form against the linked SOP.
Plan work packages with internal and external staffing effort, record non-staff costs per project, and see at a glance how much budget is already committed.
Create NDAs and sponsor contracts from any template, let AI detect clauses and deadlines, and send them straight out for electronic signature.
Manage address data for sponsors, investors, CROs and contract physicians in one CRM. Contracts and signatories link straight to the matching contact.
With the Brevo integration you send project updates and quarterly news to your investor and sponsor list, segmented by role.
Plan work packages with internal and external staffing effort and keep resources under control.
Record non-staff costs per project. Handover to financial planning (in preparation).
Release the SOP with an electronic signature and distribute it to the recipient groups for training.
Maintenance and calibration arrive as work orders on time; the evidence is filed as a QM record against the SOP.
Generate an NDA from any template and send it straight out for digital signature.
Contracts and signatories connect to your contacts in the CRM.
See how vemix connects GMP quality management, equipment maintenance, research planning, contracts and signatures in a single suite.