anicomply

anicomply

anic GmbH
Qualitum anicomply

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Qualitum:

About

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.
anicomply:

About

anicomply is an eBR-first Intelligence Platform for regulated manufacturing. It uses existing, structured Microsoft Word recipes and manufacturing instructions as the starting point for executable digital batch workflows, rather than simply displaying paper forms on a screen. Declarative, no-code-oriented design helps process teams create and adapt workflows with less dependence on programming. Depending on configuration, audit trails, electronic signatures, version control and four-eyes review support controlled execution and traceability. Structured data can support QA review by exception. The browser-based platform supports cloud or on-premises deployment and German and English user interfaces. Integration with existing ERP, MES, and SCADA environments is scoped to the specific project. Available functionality depends on the agreed scope and configuration. Explore your own Master Batch Record in a structured demo or Proof of Value.
Qualitum:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
anicomply:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
Qualitum:

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
anicomply:

Audience

For pharmaceutical and biotech manufacturers, CMOs and CDMOs, API producers, and quality-critical chemical operations managing changing recipes or product variants. Relevant roles include production and plant managers, process owners, QA and CSV teams, and IT/OT leads. The common challenge: turning paper-based instructions and batch documentation into controlled, traceable workflows without losing sight of review and approval needs.
Qualitum:

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported
anicomply:

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported
Qualitum:

API

Offers API Not Supported
anicomply:

API

Offers API Not Supported
Qualitum:

Screenshots and Videos

No images available
anicomply:

Screenshots and Videos

No images available
Qualitum:

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported
anicomply:

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported
Qualitum:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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anicomply:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
Qualitum:

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported
anicomply:

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported
Qualitum:

Company Information

Qualitum
qualitum.ai
anicomply:

Company Information

anic GmbH
Founded: 1996
Germany
www.anic-gmbh.de
Qualitum:

Alternatives

anicomply:

Alternatives

Qualitum:
Amici

Amici

Amici Procurement Solutions
anicomply:
Qualitum:
anicomply:
POMS MES

POMS MES

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Qualitum:
Merit for Life Science

Merit for Life Science

Merit Solutions
anicomply:
Qualitum:
Res_Q

Res_Q

Sware
anicomply:
CaliberBRM

CaliberBRM

Caliber Technologies
Qualitum:

Categories

anicomply:

Categories

Qualitum:

Integrations

No info available.
anicomply:

Integrations

No info available.
Qualitum:
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