Solution · Pharma & biotech

Pharma carries enough risk.
Your GMP paperwork should not.

Control 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.

GMP document control Internal & external effort Digital signature included
Project · ONK-204 Phase IBudget
Internal staff48.500 €
External staff (CRO)132.000 €
Non-staff costs27.800 €
Committed208.300 €
72 % of 290,000 € total budget
NDA · Nordmann Pharma
VV-2026-0148
Signed · 15/03/2026
SOP · Cleanroom hygiene
SOP-QA-012 · Rev. 4
Effective QA release
The reality in research and manufacturing

Where pharma and biotech teams lose time and money

Four typical bottlenecks and the module that fits each one.

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 module

Project costs spiral out of control

Internal effort, expensive CRO hours and non-staff costs scatter across spreadsheets and people. By quarter-end the overview is gone.

Project management module

Contracts and NDAs pile up

Sponsor contracts, non-disclosure agreements, service agreements with CROs, each with its own deadline. Signatures drag on for weeks.

Contract & digital signature

Contact data is scattered

Sponsors, investors, CROs and contract physicians in inboxes and spreadsheets. Who spoke to whom last?

CRM module
Quality management (GMP)

Every SOP controlled, every training documented, every deviation tracked

Control 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.

  • Document control with revisions, approval workflow and a sealed PDF/A rendition
  • Training with self-study, knowledge tests and qualification lock
  • Deviation and CAPA: reporting from a smartphone too, effectiveness check with a due date
View module
QM recordsMy QM
SOP-QA-012 · Cleanroom hygiene
Rev. 4 · QA release 02/03/2026
Effective
ABW-2026-0014 · Deviation
Filling line 2 · 30-day investigation deadline
Under investigation
CAPA-2026-0007
Effectiveness check · 14/04/2026
Check due
Training · SOP-QA-012 Rev. 4
47 of 50 people trained
94 %
Signature with re-authentication (password, optionally TOTP) · hash-chained audit trail
Maintenance ordersLab 2
Analytical balance AW-03 · calibration
WA-2026-0042 · due 28/10/2026
Due in 2 days
Biosafety cabinet SW-01 · function check
WA-2026-0039 · due 23/10/2026
Overdue
Incubator BS-02 · temperature mapping
WA-2026-0036 · QM evidence closed
Done
Evidence as a QM record · signature and audit trail in quality management
Maintenance

Every device maintained and calibrated on time

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.

  • Intervals on a fixed calendar rhythm or from the last actual completion
  • Work orders in the task inbox and daily digest, deputy and escalation included
  • SOP revision pinned at start, QM evidence mandatory if required, deviation straight from the finding
View module
Project management

Keep research budgets under control

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.

  • Internal and external staffing effort planned separately
  • Non-staff costs per project; handover to financial planning (in preparation)
  • Gantt with dependencies for phases and milestones
View module
ONK-204 · Phase I
Cost overview · Q1 2026
Active
Internal staff · 312 h48.500 €
External staff · CRO132.000 €
Non-staff costs · lab27.800 €
Committed of 290,000 €208.300 €
72 % committed81,700 € available
Contracts & NDAs4 open deadlines
Sponsor contract · Nordmann Pharma
VV-2026-0148
Deadline 14 days
NDA · CRO BioAnalytik
Template · standard NDA
To sign
NDA · Investor Mandl Capital
Signed · 15/03/2026 · 11:42
Signed
Audit trail & RFC-3161 timestamp per signature
Contracts & digital signature

From template to signed NDA in minutes

Create NDAs and sponsor contracts from any template, let AI detect clauses and deadlines, and send them straight out for electronic signature.

  • Generate and send an NDA from any template
  • Deadlines tracked automatically: AI detects notice and term clauses
  • Digital signature with timestamp included
View module
CRM

Sponsors, investors and CROs in one place

Manage address data for sponsors, investors, CROs and contract physicians in one CRM. Contracts and signatories link straight to the matching contact.

  • Contacts, companies and deals in one pipeline
  • Contracts & signed NDAs linked to the contact
  • Role tags: sponsor, investor, CRO, contract physician
View module
Contacts128 active
AV
Dr. Anja Vogel
Nordmann Pharma
Sponsor
TM
Thomas Mandl
Mandl Capital
Investor
BN
BioAnalytik Nord
Contract lab
CRO
MK
Dr. Martin Köhler
Study centre South
Contract physician
Investor relations

Keep investors informed straight from the CRM

With the Brevo integration you send project updates and quarterly news to your investor and sponsor list, segmented by role.

In sync with Brevo
name@investor.comSubscribe
Quarterly report and project updates
A typical workflow

From research idea through SOP and the lab to signed agreement

01

Plan the project

Plan work packages with internal and external staffing effort and keep resources under control.

02

Capture non-staff costs

Record non-staff costs per project. Handover to financial planning (in preparation).

03

Release SOP & train

Release the SOP with an electronic signature and distribute it to the recipient groups for training.

04

Maintain equipment

Maintenance and calibration arrive as work orders on time; the evidence is filed as a QM record against the SOP.

05

Create an NDA

Generate an NDA from any template and send it straight out for digital signature.

06

Link to contacts

Contracts and signatories connect to your contacts in the CRM.

Bring quality, lab, research, contracts and contacts together

See how vemix connects GMP quality management, equipment maintenance, research planning, contracts and signatures in a single suite.