What is Novaqis LIMS?

Novaqis LIMS is pharmaceutical laboratory information management software designed for 21 CFR Part 11 QC labs. It covers sample accessioning, formula worksheets, volumetric standardization, 2-phase OOS/OOT, ICH stability, cleanroom EM, instrument capture, and release support with site-wide licensing instead of per-seat fees.

Who should evaluate Novaqis LIMS?

Pharma, biotech, sterile manufacturing, and commercial testing laboratories that need paperless QC with Part 11 / Annex 11 controls—especially teams replacing spreadsheet-centric workflows or expensive per-seat LIMS licenses.

Is Novaqis LIMS suitable for 21 CFR Part 11?

Yes. Novaqis LIMS is designed with immutable audit trails, electronic signatures, reason-for-change, and role segregation to support Part 11 and EU Annex 11 validation narratives. Customers still complete validation in their environment.

How does Novaqis LIMS handle dynamic mathematical formula worksheets?

Novaqis LIMS features a visual mathematical formula calculation engine that dynamically evaluates complex equations (Assays, Related Substances, LOD, KF Water, Dissolution profiles) with double-blind data entry verification and automated USP/EP/BP/IP precision rounding rules.

How are 2-Phase OOS investigations managed in Novaqis LIMS per US FDA guidance?

Novaqis LIMS provides a regulated 2-phase investigation workflow: Phase 1 laboratory root-cause checklist (analyst, instrument, glassware, system suitability) and Phase 2 manufacturing investigation with 5-Why root-cause trees and Ishikawa fishbone diagrams, directly escalating to QMS CAPA.

Does Novaqis LIMS support cloud hosting as well as on-premises deployment?

Yes. Novaqis LIMS can be deployed on a dedicated validated private cloud (AWS, Azure, GCP) with a 99.99% high-availability target or on-premises on plant servers with offline ES256 cryptographic licensing.

How does Novaqis LIMS relate to Novaqis InstrumentLink?

Novaqis LIMS includes IDAS for in-product instrument capture. Novaqis InstrumentLink is the official Instrument SDK for multi-site fleet interlinking across chromatography and non-chromatography systems and all major LIMS — use them together for end-to-end lab automation.

How do we get started with Novaqis LIMS?

Request a demo or contact Novaqis for a scoped QC assessment via the Contact page. Engagements typically cover worksheet digitization (Lab Digitize), instrument automation (InstrumentLink), and site licensing.

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GxP-ready themes21 CFR Part 11EU Annex 11

NovaqisLIMS

The Enterprise 22-Module Paperless LIMS & Lab Informatics Platform

Novaqis LIMS is a 21 CFR Part 11 laboratory information management system for pharmaceutical and biotech QC. It unifies sample accessioning, dynamic formula worksheets, volumetric standardization, 2-phase OOS/OOT, ICH stability, cleanroom EM, instrument capture, and QP release support in one paperless LIMS—with site-wide licensing instead of per-user seat fees.

Automated Sample Accessioning & Chain of Custody
Dynamic ASTM E29 Pharma Math & Trailing-Zero Preservation
Volumetric Solution Standardization (Normality Math & %RSD ≤ 0.20%)
HPLC / GC Column Injections & Maximum Capacity Lockouts

Schedule a Demo Calculate Batch ROI All Products

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All 14 HPLC chromatographic peak integrations verified against standard limits with no mathematical anomalies detected. Volumetric NaOH titrant remains within the valid calibration window (Factor: 1.002).

All checks passed21 CFR Part 11 Compliant

At a glance

22Complete Lab Modules

100%21 CFR Part 11 Compliant

0Per-User Seat Fees

SAPERP Usage Decision

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All checks passed21 CFR Part 11 Compliant

At a glance

22Complete Lab Modules

100%21 CFR Part 11 Compliant

0Per-User Seat Fees

SAPERP Usage Decision

Enterprise Architecture

Platform capabilities grounded in how you validate and operate

Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.

Tier-1 Core Architecture

Automated Sample Accessioning & Chain of Custody

End-to-end sample lifecycle tracking for raw materials, in-process, finished pharmaceuticals, packaging materials, and stability batches. Includes barcode / RFID labeling, aliquot splitting, automated test allocation to benches (Chemical, Microbiological, Instrumental), and an immutable electronic chain-of-custody log.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Regulatory Interlock

Dynamic ASTM E29 Pharma Math & Trailing-Zero Preservation

Visual formula builder executes complex multi-variable calculations dynamically (e.g. Assay, Related Substances, Dissolution profiles). Enforces strict ASTM E29 significant figure rules, trailing-zero preservation, and automated specification breach quarantine.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Volumetric Solution Standardization (Normality Math & %RSD ≤ 0.20%)

Standardize titrant solutions with validated stoichiometry formulas (N = [W × Purity] / [V × Eq. Factor]), USP %RSD ≤ 0.20% replicate acceptance gates, temperature compensation factor correction (Nt = N0 × [1 - α(T - T0)]), and auto-lockout when restandardization windows expire.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

HPLC / GC Column Injections & Maximum Capacity Lockouts

Comprehensive chromatographic column registry tracking cumulative injections across mobile phases. Automatically flags warnings and locks out analytical columns when maximum rated injection capacity is breached.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Working Standards Lot Tracking & Potency Mg/Mg Governance

Comprehensive reference and working standard inventory with verified purity %, potency mg/mg factor adjustments, storage temperature monitoring, auto-quarantine on validity window expiry, and dual-witness QA destruction protocols.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Regulated 2-Phase OOS / OOT / OOE Investigation Workflow

Strict GxP 2-phase investigation engine: Phase 1 laboratory error hypothesis checklist, analyst interview, instrument audit, and sample re-testing rules; Phase 2 manufacturing root cause investigation with 5-Why and Ishikawa fishbone trees, directly escalating to QMS CAPA workflows.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

ICH Q1A(R2) Stability Study Protocol Scheduling & Grace Windows

Automate long-term, intermediate, and accelerated ICH climatic storage protocols (25°C/60%RH, 30°C/65%RH, 40°C/75%RH). Features automated interval pull date scheduling with regulatory grace windows and degradation shelf-life regression analysis.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Cleanroom Grade A/B/C/D Environmental Monitoring (EM)

Interactive cleanroom facility mapping with scheduled air sampling, settle plate exposure, surface contact swabs, and personnel monitoring logs. Configurable alert and action limits with immediate excursion triggers and trend analytics.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

IDAS IoT Instrument Data Acquisition System

In-LIMS capture from laboratory hardware (HPLC, GC, UV-Vis, FTIR, TOC, Karl Fischer, analytical balances) via serial, network, and file-based paths. For multi-site fleet interlinking across chromatography and non-chromatography systems — and any major LIMS — see Novaqis InstrumentLink, the official Instrument SDK. For master and worksheet cutover from paper or digital QC packs, see Novaqis Lab Digitize.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Statistical Quality Control (SQC) & Shewhart Control Charts

Real-time Shewhart, Levey-Jennings, and CUSUM control charts with automated Westgard rule evaluation. Automatically detects Out-of-Trend (OOT), shifts, and drifts in analytical data before specifications are breached.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Automated Multilingual Certificate of Analysis (CoA) Engine

Instant CoA document generation mapped against multi-market pharmacopeia limits (USP, EP, BP, IP). Includes anti-tamper cryptographic QR verification, dynamic digital watermarking, and dual QC/QA electronic signatures.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Qualified Person (QP) Batch Release Decision Support

Consolidates analytical testing certificates, environmental monitoring clearances, deviation history, and manufacturing batch execution dossiers into a unified QP release gate, ensuring 100% compliance before market authorization.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Bidirectional ERP / SAP QM Integration & Usage Decision

Native synchronization with SAP QM, Oracle NetSuite, and Microsoft Dynamics: automatically pull inspection lots on material arrival and post automated Usage Decisions (UD) and inventory stock status (Unrestricted, Blocked, Quarantined) upon final QA disposition.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Zero Per-Seat User Licensing Model (5x Lower TCO)

Eliminate restrictive per-seat named user penalties ($3,000+/user/year). Novaqis LIMS provides an enterprise site-wide license with unlimited analysts, lab technicians, supervisors, and QA reviewers on the same predictable subscription.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

100% 21 CFR Part 11, EU Annex 11 & ALCOA+ Data Integrity

Complete regulatory compliance with immutable system-generated audit trails, time-stamped reasons for change, biometric and dual-factor e-signatures, granular role-based segregation of duties, and zero database backdoors.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

22-Module Native QC Engine

Paperless Lab Execution with Direct Instrument Telemetry

Tear down desktop spreadsheets and disconnected sample logs. Novaqis LIMS connects analytical balances, HPLCs, and dissolution testers directly to validated test worksheets.

Architecture Spec100% Part 11

Math Precision:ASTM E29 Round-to-Even

Instrument Protocols:RS-232, TCP/IP, Modbus

OOS Escalation:Phase 1 & Phase 2 Automated

ERP Integration:Native SAP Usage Decision

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

Schedule LIMS Deep-Dive Demo

Operations HubLaboratory Testing & Sample Workload Hub

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All checks passed21 CFR Part 11 Compliant

Live bench assignment across Chemical, Microbiology, and Instrumental labs. Monitor active sample accessioning, volumetric titrant standardization factors, 2-phase OOS alerts, and SQC Shewhart trends.

Formula EngineDynamic Mathematical Formula Testing Worksheets

Novaqis LIMS

LIMS / Formula Engine

Dynamic Formula Testing Worksheets

21 CFR Part 11Nova AI

WS-2026-HPLC-0891Active Worksheet

Paracetamol 500mg Tablet - Assay by HPLC (USP/EP Pharmacopeial Method)

Assay Formula

N1V1 = N2V2 · Peak Ratio

Dynamic Formula Evaluation Engine & Standard Parameters

Double-Blind Verified

Assay % = ( A_sample × W_std × Dilution_sample × Purity_std ) ÷ ( A_std × W_sample × Dilution_std ) × 100

Sample Weight (W_sample)

500.4 mg

Mettler Balance #BAL-04

Standard Weight (W_std)

100.2 mg

Certified Ref Standard

Peak Area Sample (A_s)

45,210.4

HPLC Channel A @ 243nm

Peak Area Standard (A_std)

45,188.9

RSD < 0.85% (Passed)

Calculated Assay Result (Auto-Rounded)

99.82% (Spec: 98.0% – 102.0%)

PASSED · WITHIN SPECPharmacopeial Rounding Applied

Double-Blind Verification Check

Analyst 1 Entry (Bench A):99.82%

Analyst 2 Blind Entry (Bench B):99.82%

✓ 100% Data Entry Match - Zero Discrepancy

21 CFR Part 11 Dual E-Signatures

Executed by: J. Doe (QC Analyst)21:40 UTC

Reviewed by: M. Vance (QA Manager)21:42 UTC

SHA256: 8f92a4b10e927c3d9418fae... (Cryptographically Sealed)

Automated formula evaluation (e.g. Assay, Normality N1V1=N2V2, Moisture, LOD) with double-blind data entry verification, automatic pharmacopeial rounding, and dual QA cryptographic e-signatures.

Capability depth

The 22-Module Enterprise Paperless LIMS & Laboratory Informatics Platform

Novaqis LIMS unifies sample accessioning, dynamic formula calculation worksheets, volumetric solution standardization (N1V1 = N2V2), working reference standards, 2-phase OOS investigations, ICH stability protocol automation, Grade A/B/C/D cleanroom environmental monitoring, IDAS IoT instrument automation, and QP batch release on a 99.99% high-availability architecture.

Sample Accessioning & Dynamic Math Worksheets

Automated sample logging for raw materials, in-process, finished pharmaceuticals, packaging, and stability batches with barcode/RFID labels
Digital testing worksheets with embedded formula evaluation engines (Assay, Related Substances, LOD, KF Water, Dissolution) and double-blind verification
Bench allocation matrix for Chemical, Microbiology, and Instrumental labs with automated analyst workload balancing
Automated Certificate of Analysis (CoA) generation mapped against multi-pharmacopeial limits (USP, EP, BP, IP) with crypto QR verification

Volumetric Titrants, Working Standards & ICH Stability

Volumetric solution standardization engine against primary standards with auto-calculated Normality (N1V1 = N2V2) and expiry locking
Working reference standard lot tracking, container tare weight deductions, storage monitoring, and dual-witness QA destruction authorization
ICH Q1A–Q1F stability study protocol builder, climatic chamber monitoring, and automated pull window calendar notifications
Degradation trend prediction and shelf-life regression modeling across accelerated and real-time storage conditions

2-Phase OOS, Cleanroom EM & Shewhart SQC Analytics

Regulated 2-phase OOS/OOT workflow: Phase 1 lab cause checklist and Phase 2 manufacturing root cause tree with direct QMS CAPA escalation
Cleanroom Grade A/B/C/D environmental monitoring with active air sampling, settle plates, contact swabs, and excursion alarms
Statistical Quality Control (SQC) engine with live Shewhart and Levey-Jennings charts evaluating Westgard rules for early trend detection
Microbiology water loop monitoring and bioburden / endotoxin testing logs with automated limit violation alerts

IDAS + InstrumentLink & ERP / SAP Integration

IDAS (Instrument Data Acquisition System) captures direct raw data from HPLC, GC, UV-Vis, FTIR, TOC, and analytical balances via serial and network paths
File-based CDS result ingestion to eliminate manual transcription errors — extend fleet-wide with Novaqis InstrumentLink, the official Instrument SDK
Qualified Person (QP) batch release authorization interlocked with DMS document revisions and BRM electronic batch records
Bidirectional ERP / SAP QM inspection lot synchronization with automated Usage Decision (UD) posting to release or quarantine inventory

Enterprise Benchmark & Architecture

Why Leading QC Laboratories Choose Novaqis Enterprise LIMS

Traditional enterprise LIMS platforms often burden laboratories with complex custom scripting for calculation worksheets and separate third-party add-ons for OOS, Stability, and SQC charts. Discover how Novaqis LIMS delivers 22 native modules, visual dynamic formula worksheets, automated volumetric standardization, and 99.99% high availability on a unified GxP architecture.

Dimension

Legacy LIMS Vendors

Novaqis LIMS

Value Evaluation Checklist

Licensing & Total Cost of Ownership (TCO)

Seat penalties vs unlimited lab analyst scaling

Read full comparison

Strict per-user named seat fees ($3,000+ per analyst/year) + expensive user tiers.

Site-wide license with zero per-user seat penalties (5x lower TCO).

Calculate 3-year TCO for 50+ analysts under per-seat vs Novaqis site license.
Provision unlimited analyst roles in Novaqis Admin without incurring license bill changes.

Test Worksheets & Dynamic Math Formulas

Custom SQL scripts vs digital formula engines

Read full comparison

Requires custom database stored procedures or C# script customization.

Native visual formula builder with double-blind data entry verification.

Configure a 3-variable formula in UI (Result = (Weight * Purity) / Volume).
Test double-blind entry verification and verify calculation accuracy against standard reference.

Volumetric Titrants & Working Standards

Manual lab logbooks vs automated standardization engine

Read full comparison

Volumetric solution standardization and reference standards tracked in paper logbooks or spreadsheets.

Automated Normality calculation, restandardization alerts & expiry lockouts.

Standardize a 0.1N NaOH solution against Potassium Hydrogen Phthalate in UI.
Verify automatic factor computation (Factor = 1.002) and automatic expiry lockout enforcement.

2-Phase OOS Investigations & CAPA Escalation

Siloed 3rd-party add-ons vs built-in 21 CFR Part 11 suite

Read full comparison

OOS investigations and SPC control charts sold as expensive add-on modules.

Native 2-Phase OOS with 5-Why root cause trees & direct QMS CAPA links.

Execute a 2-phase OOS investigation with Phase 1 lab cause checklist and Phase 2 CAPA link.
View live Shewhart control chart with automatic Out-of-Trend (OOT) alert generation.

ICH Stability Protocol & Climatic Chamber Management

Disjointed calendar spreadsheets vs automated pull schedule engine

Read full comparison

Stability study pull schedules managed in Excel or separate standalone software.

Automated ICH Q1A-F pull window alerts & degradation trend regression.

Create an accelerated (40°C/75%RH) stability protocol with automated 1M, 3M, 6M pull schedules.
Verify automated task allocation to testing benches on pull milestone dates.

IDAS + InstrumentLink & Bidirectional ERP / SAP QM Integration

Proprietary middleware tax vs native Instrument SDK & automated Usage Decision

Read full comparison

Costly middleware per instrument connection; manual re-keying of SAP Usage Decisions.

InstrumentLink SDK + IDAS capture + automated SAP Usage Decision posting.

Parse chromatographic or balance export data directly into a testing worksheet without manual typing.
Authorize batch release and verify automated Usage Decision payload transmission to ERP.

Strict per-user named seat fees ($3,000+ per analyst/year) + expensive user tiers.

Site-wide license with zero per-user seat penalties (5x lower TCO).

Value Evaluation Checklist

Calculate 3-year TCO for 50+ analysts under per-seat vs Novaqis site license.

+1 more evaluation item in the full comparison - expand above.

Requires custom database stored procedures or C# script customization.

Native visual formula builder with double-blind data entry verification.

Value Evaluation Checklist

Configure a 3-variable formula in UI (Result = (Weight * Purity) / Volume).

+1 more evaluation item in the full comparison - expand above.

Volumetric solution standardization and reference standards tracked in paper logbooks or spreadsheets.

Automated Normality calculation, restandardization alerts & expiry lockouts.

Value Evaluation Checklist

Standardize a 0.1N NaOH solution against Potassium Hydrogen Phthalate in UI.

+1 more evaluation item in the full comparison - expand above.

OOS investigations and SPC control charts sold as expensive add-on modules.

Native 2-Phase OOS with 5-Why root cause trees & direct QMS CAPA links.

Value Evaluation Checklist

Execute a 2-phase OOS investigation with Phase 1 lab cause checklist and Phase 2 CAPA link.

+1 more evaluation item in the full comparison - expand above.

Stability study pull schedules managed in Excel or separate standalone software.

Automated ICH Q1A-F pull window alerts & degradation trend regression.

Value Evaluation Checklist

Create an accelerated (40°C/75%RH) stability protocol with automated 1M, 3M, 6M pull schedules.

+1 more evaluation item in the full comparison - expand above.

Costly middleware per instrument connection; manual re-keying of SAP Usage Decisions.

InstrumentLink SDK + IDAS capture + automated SAP Usage Decision posting.

Value Evaluation Checklist

Parse chromatographic or balance export data directly into a testing worksheet without manual typing.

+1 more evaluation item in the full comparison - expand above.

Comparison reflects standard market licensing and architecture patterns. Your validation evidence and requirements always win.

Full suite evaluation guide Schedule a demo

Regulatory alignment

Built for inspections from day one

21 CFR Part 11 themesEU Annex 11 / GMP themesALCOA+ data integrityValidation-ready deployment

Market Benchmarks

Industry & Platform Comparisons

Paperless LIMS Software AlternativeTop 5 Legacy LIMS Alternatives for QC Labs (2026 Guide)

Paperless LIMS Software AlternativeNovaqis LIMS vs LabWare LIMS®: Modern Pharmaceutical QC Laboratory Benchmark (2026)

Paperless LIMS Software AlternativeNovaqis LIMS vs Caliber LIMS®: Pharmaceutical QC Laboratory Comparison (2026)

Pharma Laboratory Informatics BenchmarkBest Pharma LIMS in India: 22-Module Paperless Laboratory Benchmark (2026)

Instrument SDK & LIMS InterlinkingBest Instrument SDK for LIMS Interlinking (2026): Bidirectional Fleet Automation

LIMS Method DigitizationBest LIMS Method Digitization Software (2026): Linked Masters, AI Review & Readiness Scorecards

Technical Research

Architecture & Compliance Guides

Top 10 Pharma LIMS Software & Enterprise QC Laboratory Benchmark (2026)The 22-Module Paperless LIMS Architecture: Mathematical Formulas, Titrant Standardization & 2-Phase OOS (2026 Master Guide)Automating Pharmacopeial Calculations in LIMS: USP <921> Karl Fischer, USP <711> Dissolution & Assay Worksheets USP <1058> Analytical Instrument Qualification (AIQ) & Calibration: DQ, IQ, OQ, PQ in Modern Pharma Labs ICH Q1A–Q1F Stability Study Protocol & Chamber Pull Automation Guide for QC Labs What Is an Instrument SDK for LIMS? Category Guide for QC & ARD Labs LIMS–CDS Interlinking Buyer’s Guide: Chromatography, Non-Chrom & Bidirectional Automation What Is LIMS Method Digitization? Linked Masters, Review & Readiness LIMS Migration Buyer’s Guide (Any Platform): Assessment, Adapters & Validation

Glossary

Related compliance terms

USP <711> Dissolution OOS investigation Volumetric standardization Instrument SDK

Next step

Tools & contact

Instrument interlink TCO calculator Talk to Novaqis

Ready to see Novaqis LIMS in action?

Talk to our team about how Novaqis LIMS fits your validation and compliance requirements.

Schedule a Demo Suite integrations GxP decision tools Explore all products

FAQ

Novaqis LIMS FAQ

: Novaqis LIMS is pharmaceutical laboratory information management software designed for 21 CFR Part 11 QC labs. It covers sample accessioning, formula worksheets, volumetric standardization, 2-phase OOS/OOT, ICH stability, cleanroom EM, instrument capture, and release support with site-wide licensing instead of per-seat fees.

Loading products…

GxP-ready themes21 CFR Part 11EU Annex 11

NovaqisLIMS

The Enterprise 22-Module Paperless LIMS & Lab Informatics Platform

Automated Sample Accessioning & Chain of Custody
Dynamic ASTM E29 Pharma Math & Trailing-Zero Preservation
Volumetric Solution Standardization (Normality Math & %RSD ≤ 0.20%)
HPLC / GC Column Injections & Maximum Capacity Lockouts

Schedule a Demo Calculate Batch ROI All Products

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All checks passed21 CFR Part 11 Compliant

At a glance

22Complete Lab Modules

100%21 CFR Part 11 Compliant

0Per-User Seat Fees

SAPERP Usage Decision

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All checks passed21 CFR Part 11 Compliant

At a glance

22Complete Lab Modules

100%21 CFR Part 11 Compliant

0Per-User Seat Fees

SAPERP Usage Decision

Enterprise Architecture

Platform capabilities grounded in how you validate and operate

Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.

Tier-1 Core Architecture

Automated Sample Accessioning & Chain of Custody

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Regulatory Interlock

Dynamic ASTM E29 Pharma Math & Trailing-Zero Preservation

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Volumetric Solution Standardization (Normality Math & %RSD ≤ 0.20%)

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

HPLC / GC Column Injections & Maximum Capacity Lockouts

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Working Standards Lot Tracking & Potency Mg/Mg Governance

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Regulated 2-Phase OOS / OOT / OOE Investigation Workflow

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

ICH Q1A(R2) Stability Study Protocol Scheduling & Grace Windows

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Cleanroom Grade A/B/C/D Environmental Monitoring (EM)

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

IDAS IoT Instrument Data Acquisition System

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Statistical Quality Control (SQC) & Shewhart Control Charts

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Automated Multilingual Certificate of Analysis (CoA) Engine

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Qualified Person (QP) Batch Release Decision Support

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Bidirectional ERP / SAP QM Integration & Usage Decision

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Zero Per-Seat User Licensing Model (5x Lower TCO)

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

100% 21 CFR Part 11, EU Annex 11 & ALCOA+ Data Integrity

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

22-Module Native QC Engine

Paperless Lab Execution with Direct Instrument Telemetry

Tear down desktop spreadsheets and disconnected sample logs. Novaqis LIMS connects analytical balances, HPLCs, and dissolution testers directly to validated test worksheets.

Architecture Spec100% Part 11

Math Precision:ASTM E29 Round-to-Even

Instrument Protocols:RS-232, TCP/IP, Modbus

OOS Escalation:Phase 1 & Phase 2 Automated

ERP Integration:Native SAP Usage Decision

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

Schedule LIMS Deep-Dive Demo

Operations HubLaboratory Testing & Sample Workload Hub

Novaqis LIMS

LIMS / Lab Dashboard

Laboratory Testing & Sample Workload Hub

21 CFR Part 11Nova AI

Active Samples

184

14 received today

Worksheets In-Testing

Bench assigned

Titrant Factor (NaOH)

1.002

0.1002 N - valid

OOS Phase 1 Alerts

Lab cause pending

Active Worksheets and Formula Calculations

Formula Engine: N1V1 = N2V2

Sample ID	Product	Method	Spec	Result	Status
SMP-2026-0891	Paracetamol 500mg Tab	Assay by HPLC	98.0 – 102.0%	99.82%	Verified
SMP-2026-0892	WFI Water Loop B	Microbial Count	< 10 CFU/100mL	1 CFU/100mL	Completed
SMP-2026-0893	Sodium Hydroxide 0.1N	Standardization	0.0995 – 0.1005 N	0.1002 N	Standardized
SMP-2026-0894	Amoxicillin Trihydrate	Moisture Content	≤ 14.5%	13.84%	QA Review

SQC Shewhart Trend

UCL: 101.2% | LCL: 98.5%

Nova AI Laboratory Intelligence

All checks passed21 CFR Part 11 Compliant

Formula EngineDynamic Mathematical Formula Testing Worksheets

Novaqis LIMS

LIMS / Formula Engine

Dynamic Formula Testing Worksheets

21 CFR Part 11Nova AI

WS-2026-HPLC-0891Active Worksheet

Paracetamol 500mg Tablet - Assay by HPLC (USP/EP Pharmacopeial Method)

Assay Formula

N1V1 = N2V2 · Peak Ratio

Dynamic Formula Evaluation Engine & Standard Parameters

Double-Blind Verified

Assay % = ( A_sample × W_std × Dilution_sample × Purity_std ) ÷ ( A_std × W_sample × Dilution_std ) × 100

Sample Weight (W_sample)

500.4 mg

Mettler Balance #BAL-04

Standard Weight (W_std)

100.2 mg

Certified Ref Standard

Peak Area Sample (A_s)

45,210.4

HPLC Channel A @ 243nm

Peak Area Standard (A_std)

45,188.9

RSD < 0.85% (Passed)

Calculated Assay Result (Auto-Rounded)

99.82% (Spec: 98.0% – 102.0%)

PASSED · WITHIN SPECPharmacopeial Rounding Applied

Double-Blind Verification Check

Analyst 1 Entry (Bench A):99.82%

Analyst 2 Blind Entry (Bench B):99.82%

✓ 100% Data Entry Match - Zero Discrepancy

21 CFR Part 11 Dual E-Signatures

Executed by: J. Doe (QC Analyst)21:40 UTC

Reviewed by: M. Vance (QA Manager)21:42 UTC

SHA256: 8f92a4b10e927c3d9418fae... (Cryptographically Sealed)

Automated formula evaluation (e.g. Assay, Normality N1V1=N2V2, Moisture, LOD) with double-blind data entry verification, automatic pharmacopeial rounding, and dual QA cryptographic e-signatures.

Capability depth

The 22-Module Enterprise Paperless LIMS & Laboratory Informatics Platform

Sample Accessioning & Dynamic Math Worksheets

Automated sample logging for raw materials, in-process, finished pharmaceuticals, packaging, and stability batches with barcode/RFID labels
Digital testing worksheets with embedded formula evaluation engines (Assay, Related Substances, LOD, KF Water, Dissolution) and double-blind verification
Bench allocation matrix for Chemical, Microbiology, and Instrumental labs with automated analyst workload balancing
Automated Certificate of Analysis (CoA) generation mapped against multi-pharmacopeial limits (USP, EP, BP, IP) with crypto QR verification

Volumetric Titrants, Working Standards & ICH Stability

Volumetric solution standardization engine against primary standards with auto-calculated Normality (N1V1 = N2V2) and expiry locking
Working reference standard lot tracking, container tare weight deductions, storage monitoring, and dual-witness QA destruction authorization
ICH Q1A–Q1F stability study protocol builder, climatic chamber monitoring, and automated pull window calendar notifications
Degradation trend prediction and shelf-life regression modeling across accelerated and real-time storage conditions

2-Phase OOS, Cleanroom EM & Shewhart SQC Analytics

Regulated 2-phase OOS/OOT workflow: Phase 1 lab cause checklist and Phase 2 manufacturing root cause tree with direct QMS CAPA escalation
Cleanroom Grade A/B/C/D environmental monitoring with active air sampling, settle plates, contact swabs, and excursion alarms
Statistical Quality Control (SQC) engine with live Shewhart and Levey-Jennings charts evaluating Westgard rules for early trend detection
Microbiology water loop monitoring and bioburden / endotoxin testing logs with automated limit violation alerts

IDAS + InstrumentLink & ERP / SAP Integration

IDAS (Instrument Data Acquisition System) captures direct raw data from HPLC, GC, UV-Vis, FTIR, TOC, and analytical balances via serial and network paths
File-based CDS result ingestion to eliminate manual transcription errors — extend fleet-wide with Novaqis InstrumentLink, the official Instrument SDK
Qualified Person (QP) batch release authorization interlocked with DMS document revisions and BRM electronic batch records
Bidirectional ERP / SAP QM inspection lot synchronization with automated Usage Decision (UD) posting to release or quarantine inventory

Enterprise Benchmark & Architecture

Why Leading QC Laboratories Choose Novaqis Enterprise LIMS

Dimension

Legacy LIMS Vendors

Novaqis LIMS

Value Evaluation Checklist

Licensing & Total Cost of Ownership (TCO)

Seat penalties vs unlimited lab analyst scaling

Read full comparison

Strict per-user named seat fees ($3,000+ per analyst/year) + expensive user tiers.

Site-wide license with zero per-user seat penalties (5x lower TCO).

Calculate 3-year TCO for 50+ analysts under per-seat vs Novaqis site license.
Provision unlimited analyst roles in Novaqis Admin without incurring license bill changes.

Test Worksheets & Dynamic Math Formulas

Custom SQL scripts vs digital formula engines

Read full comparison

Requires custom database stored procedures or C# script customization.

Native visual formula builder with double-blind data entry verification.

Configure a 3-variable formula in UI (Result = (Weight * Purity) / Volume).
Test double-blind entry verification and verify calculation accuracy against standard reference.

Volumetric Titrants & Working Standards

Manual lab logbooks vs automated standardization engine

Read full comparison

Volumetric solution standardization and reference standards tracked in paper logbooks or spreadsheets.

Automated Normality calculation, restandardization alerts & expiry lockouts.

Standardize a 0.1N NaOH solution against Potassium Hydrogen Phthalate in UI.
Verify automatic factor computation (Factor = 1.002) and automatic expiry lockout enforcement.

2-Phase OOS Investigations & CAPA Escalation

Siloed 3rd-party add-ons vs built-in 21 CFR Part 11 suite

Read full comparison

OOS investigations and SPC control charts sold as expensive add-on modules.

Native 2-Phase OOS with 5-Why root cause trees & direct QMS CAPA links.

Execute a 2-phase OOS investigation with Phase 1 lab cause checklist and Phase 2 CAPA link.
View live Shewhart control chart with automatic Out-of-Trend (OOT) alert generation.

ICH Stability Protocol & Climatic Chamber Management

Disjointed calendar spreadsheets vs automated pull schedule engine

Read full comparison

Stability study pull schedules managed in Excel or separate standalone software.

Automated ICH Q1A-F pull window alerts & degradation trend regression.

Create an accelerated (40°C/75%RH) stability protocol with automated 1M, 3M, 6M pull schedules.
Verify automated task allocation to testing benches on pull milestone dates.

IDAS + InstrumentLink & Bidirectional ERP / SAP QM Integration

Proprietary middleware tax vs native Instrument SDK & automated Usage Decision

Read full comparison

Costly middleware per instrument connection; manual re-keying of SAP Usage Decisions.

InstrumentLink SDK + IDAS capture + automated SAP Usage Decision posting.

Parse chromatographic or balance export data directly into a testing worksheet without manual typing.
Authorize batch release and verify automated Usage Decision payload transmission to ERP.

Strict per-user named seat fees ($3,000+ per analyst/year) + expensive user tiers.

Site-wide license with zero per-user seat penalties (5x lower TCO).

Value Evaluation Checklist

Calculate 3-year TCO for 50+ analysts under per-seat vs Novaqis site license.

+1 more evaluation item in the full comparison - expand above.

Requires custom database stored procedures or C# script customization.

Native visual formula builder with double-blind data entry verification.

Value Evaluation Checklist

Configure a 3-variable formula in UI (Result = (Weight * Purity) / Volume).

+1 more evaluation item in the full comparison - expand above.

Volumetric solution standardization and reference standards tracked in paper logbooks or spreadsheets.

Automated Normality calculation, restandardization alerts & expiry lockouts.

Value Evaluation Checklist

Standardize a 0.1N NaOH solution against Potassium Hydrogen Phthalate in UI.

+1 more evaluation item in the full comparison - expand above.

OOS investigations and SPC control charts sold as expensive add-on modules.

Native 2-Phase OOS with 5-Why root cause trees & direct QMS CAPA links.

Value Evaluation Checklist

Execute a 2-phase OOS investigation with Phase 1 lab cause checklist and Phase 2 CAPA link.

+1 more evaluation item in the full comparison - expand above.

Stability study pull schedules managed in Excel or separate standalone software.

Automated ICH Q1A-F pull window alerts & degradation trend regression.

Value Evaluation Checklist

Create an accelerated (40°C/75%RH) stability protocol with automated 1M, 3M, 6M pull schedules.

+1 more evaluation item in the full comparison - expand above.

Costly middleware per instrument connection; manual re-keying of SAP Usage Decisions.

InstrumentLink SDK + IDAS capture + automated SAP Usage Decision posting.

Value Evaluation Checklist

Parse chromatographic or balance export data directly into a testing worksheet without manual typing.

+1 more evaluation item in the full comparison - expand above.

Comparison reflects standard market licensing and architecture patterns. Your validation evidence and requirements always win.

Full suite evaluation guide Schedule a demo

Regulatory alignment

Built for inspections from day one

21 CFR Part 11 themesEU Annex 11 / GMP themesALCOA+ data integrityValidation-ready deployment

Market Benchmarks

Industry & Platform Comparisons

Paperless LIMS Software AlternativeTop 5 Legacy LIMS Alternatives for QC Labs (2026 Guide)

Paperless LIMS Software AlternativeNovaqis LIMS vs LabWare LIMS®: Modern Pharmaceutical QC Laboratory Benchmark (2026)

Paperless LIMS Software AlternativeNovaqis LIMS vs Caliber LIMS®: Pharmaceutical QC Laboratory Comparison (2026)

Pharma Laboratory Informatics BenchmarkBest Pharma LIMS in India: 22-Module Paperless Laboratory Benchmark (2026)

Instrument SDK & LIMS InterlinkingBest Instrument SDK for LIMS Interlinking (2026): Bidirectional Fleet Automation

LIMS Method DigitizationBest LIMS Method Digitization Software (2026): Linked Masters, AI Review & Readiness Scorecards

Technical Research

Architecture & Compliance Guides

Glossary

Related compliance terms

USP <711> Dissolution OOS investigation Volumetric standardization Instrument SDK

Next step

Tools & contact

Instrument interlink TCO calculator Talk to Novaqis

Ready to see Novaqis LIMS in action?

Talk to our team about how Novaqis LIMS fits your validation and compliance requirements.

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FAQ

Novaqis LIMS FAQ

: Novaqis LIMS is pharmaceutical laboratory information management software designed for 21 CFR Part 11 QC labs. It covers sample accessioning, formula worksheets, volumetric standardization, 2-phase OOS/OOT, ICH stability, cleanroom EM, instrument capture, and release support with site-wide licensing instead of per-seat fees.