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 does Novaqis LIMS automate volumetric titrant standardization (N1V1 = N2V2)?

Novaqis LIMS automates volumetric solution standardization against primary standards with auto-calculated normality and factor determination. It enforces re-standardization periodicity and automatically locks expired titrants from being selected on active test worksheets.

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 99.99% high-availability or 100% on-premises on plant bare-metal servers with offline ES256 cryptographic licensing.

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GxP-ready themes21 CFR Part 11EU Annex 11

Novaqis LIMS

The Enterprise 22-Module Paperless LIMS & Lab Informatics Platform

Novaqis LIMS is the industry's most advanced, 100% 21 CFR Part 11 compliant Enterprise Laboratory Information Management System. Built for pharmaceutical, biotech, sterile manufacturing, and commercial testing laboratories, it unifies sample accessioning, automated formula worksheets, volumetric solution standardization, working reference standards, 2-phase OOS/OOT investigations, ICH stability protocols, Grade A/B/C/D cleanroom environmental monitoring, IDAS IoT instrument automation, and QP batch release with zero per-user seat license penalties.

Schedule a Demo 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

Why Novaqis LIMS

Platform capabilities grounded in how you validate and operate

The points below map to real architecture and delivery choices—not generic marketing bullets.

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.

Dynamic Mathematical Formula Calculation Engine

Visual formula builder executes complex multi-variable calculations dynamically (e.g. Assay, Related Substances, Loss on Drying, Water by Karl Fischer, Dissolution profiles). Features double-blind data entry verification and automated rounding/precision rules per USP/EP pharmacopeias.

Volumetric Titrant Standardization Engine (N1V1 = N2V2)

Automate volumetric solution preparation and standardization against primary standards with auto-calculated normality and factor determination. Enforces re-standardization periodicity, temperature compensation, and automatic expiry lockouts that prevent out-of-date titrant use on worksheets.

Working Standards Lot Tracking & Certified QA Destruction

Comprehensive working reference standard inventory with potency factor tracking, tare container weight deductions, storage condition monitoring, and dual-witness QA destruction authorization protocols with electronic signature verification.

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.

ICH Q1A–Q1F Stability Study Protocol Automation

Create and execute stability protocols across ICH climatic storage conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, photo-stability). Automated chamber pull calendar notifications, tolerance windows, degradation trend prediction, and shelf-life regression analysis.

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.

IDAS IoT Instrument Data Acquisition System

Direct bidirectional and file-based data capture from laboratory hardware (HPLC, GC, UV-Vis, FTIR, TOC, Karl Fischer, analytical balances) via RS-232, TCP/IP, and CDS file parsers (Empower, Chromeleon, OpenLab), eliminating manual transcription errors entirely.

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.

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.

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.

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.

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.

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.

In the product

22 Native Modules for Paperless Lab Operations

From sample accessioning and dynamic formula worksheets to 2-phase OOS investigations, cleanroom EM, and automated SAP Usage Decision posting—fully validated on one 100% 21 CFR Part 11 compliant stack.

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

Operations Hub

Laboratory 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 Engine

Dynamic 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.

Core LIMS capabilities

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.

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

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 IoT Instrument Automation & ERP / SAP Integration

IDAS (Instrument Data Acquisition System) captures direct raw data from HPLC, GC, UV-Vis, FTIR, TOC, and analytical balances via RS-232 and TCP/IP
CDS file parsing for Empower, Chromeleon, and OpenLab to eliminate manual transcription errors and transcription data tampering
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 Instrument IoT & Bidirectional ERP / SAP QM Integration

Proprietary middleware tax vs native IoT capture & automated Usage Decision

Read full comparison

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

Native IDAS RS-232/TCP/CDS parsing + automated SAP Usage Decision posting.

Parse raw HPLC chromatographic data directly into 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.

Native IDAS RS-232/TCP/CDS parsing + automated SAP Usage Decision posting.

Value Evaluation Checklist

Parse raw HPLC chromatographic data directly into 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

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 Explore all products

Loading products…

GxP-ready themes21 CFR Part 11EU Annex 11

Novaqis LIMS

The Enterprise 22-Module Paperless LIMS & Lab Informatics Platform

Schedule a Demo 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

Why Novaqis LIMS

Platform capabilities grounded in how you validate and operate

The points below map to real architecture and delivery choices—not generic marketing bullets.

Automated Sample Accessioning & Chain of Custody

Dynamic Mathematical Formula Calculation Engine

Volumetric Titrant Standardization Engine (N1V1 = N2V2)

Working Standards Lot Tracking & Certified QA Destruction

Regulated 2-Phase OOS / OOT / OOE Investigation Workflow

ICH Q1A–Q1F Stability Study Protocol Automation

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

IDAS IoT Instrument Data Acquisition System

Statistical Quality Control (SQC) & Shewhart Control Charts

Automated Multilingual Certificate of Analysis (CoA) Engine

Qualified Person (QP) Batch Release Decision Support

Bidirectional ERP / SAP QM Integration & Usage Decision

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

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

In the product

22 Native Modules for Paperless Lab Operations

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

Operations Hub

Laboratory 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 Engine

Dynamic 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.

Core LIMS capabilities

The 22-Module Enterprise Paperless LIMS & Laboratory Informatics Platform

Complete Lab Modules

100%

21 CFR Part 11 Compliant

Per-User Seat Fees

SAP

ERP Usage Decision

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 IoT Instrument Automation & ERP / SAP Integration

IDAS (Instrument Data Acquisition System) captures direct raw data from HPLC, GC, UV-Vis, FTIR, TOC, and analytical balances via RS-232 and TCP/IP
CDS file parsing for Empower, Chromeleon, and OpenLab to eliminate manual transcription errors and transcription data tampering
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

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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

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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

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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 Instrument IoT & Bidirectional ERP / SAP QM Integration

Proprietary middleware tax vs native IoT capture & automated Usage Decision

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

Native IDAS RS-232/TCP/CDS parsing + automated SAP Usage Decision posting.

Parse raw HPLC chromatographic data directly into 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.

Native IDAS RS-232/TCP/CDS parsing + automated SAP Usage Decision posting.

Value Evaluation Checklist

Parse raw HPLC chromatographic data directly into 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

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