🧬 Life Sciences

LIMS for pharma, biotech and CRO labs

A1 LIMS gives life sciences organisations a single validated platform to manage R&D samples, stability studies, method development and regulatory submissions — with compliance built in from day one.

✓

21 CFR Part 11 & Annex 11 compliant

✓

Full GLP & GMP support

✓

Stability study & shelf-life management

✓

Validated installation — IQ/OQ/PQ available

Drug Development Pipeline Support

🔬 Discovery & Research

ELN Integration

Compound library management

HTS sample tracking

Assay result capture & analysis

⚗️ Development & Stability

GLP Ready

Stability protocol management

Method validation tracking

Out-of-trend alerting

📋 Regulatory & Submission

21 CFR Pt 11

Audit-ready electronic records

Electronic signatures

CoA & batch record generation

The Problem

What holds life sciences labs back

In regulated life sciences environments, the cost of getting data management wrong isn't just inefficiency — it's failed audits, rejected submissions, and delayed drug development.

📁

Fragmented Data Systems

R&D, QC, and regulatory teams working in separate spreadsheets and paper notebooks creates data silos that slow decision-making and increase compliance risk.

✍️

Paper-Based Audit Trails

Manual signatures, handwritten lab notebooks and paper-based SOPs make audit preparation a weeks-long exercise rather than a single-day task.

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Stability Study Complexity

Managing multiple stability protocols, time-points, storage conditions and specifications across dozens of products is nearly impossible without a dedicated system.

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Method Transfer Challenges

Transferring analytical methods between labs or sites without proper documentation leads to inconsistent results and costly re-validation exercises.

⚠️

OOS & OOT Investigation Load

Out-of-specification and out-of-trend investigations managed in spreadsheets take too long, lack structure, and leave organisations exposed in inspections.

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Poor Instrument Connectivity

Manual transcription of instrument data into separate databases creates errors, wastes analyst time and breaks the electronic data integrity required by regulators.

How A1 LIMS Helps

A validated platform for the full development lifecycle

From early-stage discovery through to commercial QC, A1 LIMS supports every phase of the life sciences workflow in a single, compliant, audit-ready system.

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Sample & Compound Management

Manage compound libraries, biological samples, reference standards and reagents with full traceability. Track storage conditions, expiry, and chain of custody across every sample.

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Stability Study Management

Design and execute ICH-compliant stability protocols. Automatic scheduling of time-point pulls, out-of-trend alerting, and shelf-life calculation built directly into the platform.

✅

OOS / OOT Investigation Workflows

Structured investigation workflows for out-of-specification and out-of-trend results. Full documentation, root cause tracking, CAPA management and electronic sign-off in one place.

✍️

Electronic Signatures & Audit Trail

21 CFR Part 11 and Annex 11 compliant electronic signatures with immutable audit trail. Every change recorded with timestamp, user identity and reason — always inspection-ready.

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Instrument & ELN Integration

Direct integration with lab instruments eliminates transcription errors. Connect to existing ELN systems or use A1 LIMS as a standalone data capture and management layer.

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CoA & Batch Record Generation

Generate certificates of analysis, batch release records and regulatory reports automatically from test data. Customisable templates for different products, markets and regulators.

Regulatory Compliance

Built for regulated life sciences environments

A1 LIMS is designed to meet the most demanding regulatory requirements in the life sciences industry. Validated installation packages, IQ/OQ/PQ documentation and ongoing compliance support available.

21 CFR Pt 11

Electronic records

Annex 11

EU GMP

GLP

Good Lab Practice

GMP

Manufacturing

ICH Q1

Stability testing

ISO 17025

Testing labs

Integrations

Fits into your existing ecosystem

A1 LIMS connects with the instruments, ELNs, and enterprise systems your life sciences teams already depend on.

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Lab Instruments & Analysers

ASTM / TCP / RS232

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Electronic Lab Notebooks

API integration

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ERP & MES Systems

SAP / Oracle

📊

Statistical Analysis

JMP / Minitab

☁️

Cloud Storage & Backup

AWS / Azure

🔒

Identity & Access Mgmt

LDAP / SAML / SSO

📋

Document Management

SharePoint / Veeva

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Business Intelligence

Power BI / Tableau

60%

Less time preparing for audits

100%

Electronic audit trail coverage

4wk

Typical go-live timeline

0px

Paper notebooks required

Customer Story

From the research floor

"Our FDA inspection was the smoothest we've ever experienced. The inspector asked for an audit trail on a specific sample — we had it on screen in under a minute. A1 LIMS gave us the data integrity infrastructure that used to take weeks to compile manually."

Dr. Aisha K.

Head of QC
PharmaGenX Ltd.

Ready to accelerate your research pipeline?

Talk to our life sciences specialists about your lab's compliance requirements, validation needs, and go-live timeline. No pressure — just a focused conversation.

✓ Validated installation available ✓ IQ/OQ/PQ support ✓ GxP compliant

LIMS for pharma, biotech and CRO labs

What holds life sciences labs back

A validated platform for the full development lifecycle

Fits into your existing ecosystem

From the research floor

A1 LIMS for every type of lab