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Digital solutions for regulated processes in pharma and chemicals. - Hintergrundbild

Digital solutions for regulated processes in pharma and chemicals.

Our experience from three decades in regulated pharma and chemical environments shapes how we deliver projects. With IT project management, custom software and our own solutions like anicomply for digital batch documentation and anicors for intelligent chemical inventory management, we combine GxP understanding, operational reality and robust execution for production, laboratory and quality processes.

+50%
Efficiency Increase
in eBR publication
100%
Data Integrity
AI-ready from the outset
= future-proof
30 Years
Experience
in regulated pharma
and chemical environments

Why companies choose anic for regulated digitization

Companies trust anic when complex processes in regulated production environments need to be digitized safely. Our experience from demanding pharma and chemical projects shows where regulatory requirements, operational reality and time pressure come together: in the fast, robust conversion of existing processes into productively usable digital systems.

With deep experience in GxP, GAMP, FDA and Annex 11-adjacent environments, we develop solutions that not only work technically but also stand up in validated operations. This is critical for companies that want to advance digitization pragmatically and with regulatory soundness.

What this means for you

How we converted paper-based recipe management (batch documentation) into a digital, auditable process

For a pharmaceutical company, existing recipe and approval processes were digitized without a lengthy large-scale project. This significantly shortened release cycles and reduced manual transfers as well as audit effort.

How we ensured GxP-compliant data integrity for research and production

Development and validation of a central archive system that cleanly maps regulatory requirements, makes data reliably available and makes audits significantly more manageable.

Our software for regulated batch and laboratory processes

anicomply

anicomply

The eBR-first platform for CMO, CDMO and pharmaceutical manufacturers who want to digitize paper-based or sluggish recipe management (batch documentation) faster. anicomply converts existing SOPs and Word-based manufacturing instructions into executable, GxP-compliant workflows within one day and can be connected to SCADA, ERP and MES-adjacent systems as needed.

Learn more about anicomply
anicors

anicors

The specialized chemical inventory management solution with powerful structure‑based similarity and substructure search, seamless LIMS/ERP/MES integration, and an internal marketplace feature to optimize costs. Can also be used in the GxP area.

Why anicors?

Digitize paper-based and dynamic production environments quickly and easily with anicomply

anicomply is a focused eBR platform for regulated production environments. Existing SOPs, Word-based instructions and batch documents can be converted into digital workflows within one day. Especially when investments are currently tightly managed, this does not result in a budget project but a significantly more efficient entry: less modeling effort, fewer tied-up specialist resources and earlier operational usability.

Faster from SOP to productive workflow

Existing manufacturing instructions and recipe documents are converted into executable eBR workflows within one day. This makes visible early what otherwise takes months, and significantly reduces external modeling effort.

Economical entry without large-scale project

When investments are currently tightly managed, a different project profile matters: fewer tied-up specialist resources, less external dependency and faster operational usability. With good preparation, a validatable pilot can be ready within about two weeks.

Suitable for digitizing paper-based and frequently changing processes

anicomply is especially relevant for companies that still work with paper or need to regularly adjust recipes. CMOs and CDMOs in particular benefit from quickly adaptable workflows for changing customer requirements, small batches and high documentation pressure.

Compliance and integration from the start

Audit trail, versioning, electronic signatures and traceable approval processes support use in GxP-regulated environments. Where required, connection to SCADA, ERP or existing MES-adjacent systems is possible.

See SOP-to-workflow live

Experiences from regulated production environments

anic, you are heroes! Despite our internal challenges, you successfully completed the project on time.

Project Manager VIP Projects
DAX40 Life Sciences & Pharma

anic is the key partner for our Advanced Data Analytics Team.

Big Data Team Lead
DAX40 Life Sciences & Pharma

Thank you for your commitment. Thank you for the productive collaboration, especially in difficult times. I always enjoyed making a difference with you.

Head of Production
Pharma & Manufacturing

In daily work, we have valued anicomply for more than 4 years - now validated - and thus also for our regulated approaches in the future.

Quality Assurance Manager
Regulated Industries

For flexible organic production and similarly complex work environments, anicomply represents an excellent solution!

Head of R&D
Specialty Chemicals & Flexible Production

Frequently asked questions about implementation, validation and integration

anicomply accelerates the recipe release process through fully digital workflows for Electronic Batch Records. Instead of releasing recipes over weeks, approvals can be completed in hours. In suitable scenarios, time savings of 50 percent and more are achievable.

Key benefits:

  • Workflows can be created with Microsoft Word, without programming.
  • Approvals can be configured for all involved stakeholders.
  • Full compliance including audit trails per FDA 21 CFR Part 11 ensures complete traceability.
  • The web application is platform-independent and usable on different devices.

A DAX40 company achieved 40 percent faster approvals and 100 percent audit compliance with anicomply. The investment typically pays for itself within 6 to 9 months.

Yes, anicomply is fully GxP-compliant and validatable. What matters is not only formal compliance, but also a manageable change and validation effort within the project.

The software meets:

  • FDA 21 CFR Part 11: Electronic signatures, immutable audit trails, timestamps
  • EU GMP Annex 11: Data security, integrity, complete traceability
  • GAMP 5 Validation: Complete IQ/OQ/PQ process with URS, FS, DS

Highlights:

  • Automatic version management of all documents
  • Four-eyes principle for critical steps
  • Highest data security through encryption
  • Seamless audit trails (Who, What, When, Why)

anicomply has been in use e.g. at a DAX company for over 3 years and is officially validated for regulated pharma environments.

Converting an existing SOP or recipe template into a working workflow can be achieved within one day. When process scope, QA approvals and test basis are prepared, a validatable pilot can be ready in about two weeks. The productive entry typically occurs within up to 3 months, depending on integrations, CSV effort and rollout scope.

Typical resources required:

  • 1 domain process owner from production or QA
  • 1 QA/CSV contact for review and validation
  • optional: 1 IT contact for interfaces or infrastructure questions
  • 1 sponsor for prioritization and approvals

anicomply is not a "Paper-on-Glass" solution, but true digital transformation.

"Paper-on-Glass" only displays PDFs – anicomply transforms Word documents into intelligent workflows:

  • Process Support: Active guidance through workflows, real-time validation
  • Quality Controls: Only allowed actions possible, errors are prevented
  • True Digitalization: SCADA integration, automatic calculations, real-time data flow
  • Agility: SOP to workflow in 120 minutes ("120-minute test")
  • Flexibility: Workflow adaptation without programming, only with Word

Time Savings: Workflow creation in minutes instead of weeks, changes in hours instead of months.

anicomply is designed as an eBR-first platform and can be connected to SCADA, SAP/ERP and MES-adjacent systems as needed. For many companies, a focused entry into batch documentation is already sufficient. Where further requirements exist, data transfer, feedback and structured exchange can be added step by step. anicomply integrates seamlessly into your existing IT landscape with flexible interfaces:

Core Systems:

  • SCADA for real-time data transfer from production and automatic reading of process values
  • SAP or ERP for connecting production and business logic with high data integrity
  • MES-adjacent systems

Technology:

  • Web application
  • Cloud or on-premise
  • Microsoft Word as workflow editor
  • Live transfer to data lakes

Standard interfaces are preconfigured, custom integrations on demand. Immediate audit access to structured data.

anic Blog

Current Insights and Expertise from the IT World

Andreas Nicklas, CEO anic GmbH, im Interview mit der phpro über pragmatische Digitalisierung in der Pharmaproduktion
14. April 2026

Interview with Andreas Nicklas in phpro – From Bottleneck to Change Routine

Yes — we're featured in phpro. And most importantly: we're not only addressing those who are already producing in a fully digital environment. In practice, a large number of pharmaceutical manufacturers — around 60–70% — are still working with paper-based batch documentation. That is exactly why the interview with Andreas Nicklas is worth reading: it explores how to approach the move toward digitalization in a pragmatic way — and why change must never become a bottleneck in the process.

Read article »
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10. December 2025

Newer C# Features You'll Actually Use

Most new language features are not for everyday uses but cover very specific problems and situations. But some of the new features found in version 8 through 14 can be very helpful in our everyday work. In this post we'd like to share some of the new features that we found helpful in our work.

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