GMP-Ready Cloud LIMS for Pharma & Chemical Testing Laboratories
Manage specifications, raw materials, in-process testing, and batch release with cryptographic Part 11 audit trails.
Dual-witness e-signatures
Pre-loaded pharmacopeial specs
Auto calibration lockout guards
Raw material quarantine to release
AUDITED FOR GLOBAL PHARMACOPEIAL & DATA INTEGRITY COMPLIANCE
Four Pillars of Pharma & Chemical Laboratory Quality Control
Eliminate paper test sheets, manual calculation errors, and data integrity citations. ExactLIMS enforces regulatory compliance at every analytical touchpoint.
Multi-Tier Pharmacopeial Specifications (USP, EP, IP, BP)
Manage multiple specification versions for raw materials, intermediates, and finished dosage forms. Compare observed results against Indian Pharmacopoeia (IP), USP, European Pharmacopoeia (EP), or British Pharmacopoeia (BP) automatically.
Inward Lot Intake: Quarantine, Release & Discard
Automated material receipt workflows. Newly arrived raw materials and chemical drums are held in 'Quarantine' status with ANSI/ASQ Z1.4 sampling calculations until all QC assays pass and QA signs off commercial release.
Dual-Witness Electronic Signatures for Review & Sign-off
Satisfy FDA 21 CFR Part 11 requirements. Enforces sequential digital sign-offs: Testing Chemist entry, Section Reviewer verification, and Head of QA release authorization with cryptographic hashes and explicit signing rationales.
Calibration Guards: Overdue Instrument Lockout
Prevent invalid analytical data. ExactLIMS monitors calibration and maintenance schedules for HPLCs, GCs, balances, and spectrophotometers. If calibration lapses, the instrument is automatically locked out from batch allocation.
Interactive Chemical Certificate of Analysis (CoA) & Audit Packet
Explore an authentic pharmaceutical CoA generated by ExactLIMS. Toggle between Active Pharmaceutical Ingredients (Paracetamol API), Finished Formulations (Metformin Tablets BP), and Specialty Chemical Solvents (HPLC Grade Acetonitrile).
Select Pharmaceutical or Chemical Matrix
EXACT PHARMA ANALYTICAL & STABILITY TESTING LABS
Quality Control Division | NABL Accreditation Cert No: TC-5912 | Drug License No: 28B/MH/1042
Plot C-14, Trans-Thane Creek Industrial Corridor, Navi Mumbai - 400705, Maharashtra, India
Material Name & Grade:
Paracetamol (Acetaminophen) Active Pharmaceutical Ingredient
Raw Material / Chemical Lot Inwarding
Manufacturer / Supplier:
Solventis Pharma Intermediates Ltd., Gujarat
Standard Monograph Reference:
Indian Pharmacopoeia (IP 2022) / United States Pharmacopeia (USP 43)
Mfg Date / Expiry (Retest):
Mfg: September 2026 | Retest: August 2031 (Retest: 60 Months)
Sample Inward & Quantity:
500.0 g (Quarantine Sample)
Instrument Calibration Guard:
Validated & Active (Calibration Valid till 20-Dec-2026)
Analytical Evaluation & Pharmacopeial Assay Results
All tests performed as per validated protocol with system suitability verified| # | Test Parameter / Investigation | Test Method / Protocol | Acceptance Criteria (Specification) | Observed Result | Status |
|---|---|---|---|---|---|
| 1 | Description & Appearance | Visual (IP / USP) | White or almost white, crystalline powder; odorless | White crystalline powder; odorless | CONFORMS |
| 2 | Identification A (IR Spectroscopy) | IP 2.4.24 / USP <197K> | Conforms to spectrum of Paracetamol Working Standard | Conforms to Paracetamol Working Standard (r = 0.998) | CONFORMS |
| 3 | Identification B (HPLC Retention Time) | IP / USP Monograph | Retention time corresponds to that of reference solution | Corresponds to Reference Standard (Rt = 4.82 min) | CONFORMS |
| 4 | Melting Range | IP 2.4.21 / USP <741> | 168.0°C to 172.0°C | 169.4°C – 170.8°C | CONFORMS |
| 5 | Water Content (Karl Fischer) | IP 2.4.12 / USP <921> | Not more than 0.5% w/w | 0.18% w/w | CONFORMS |
| 6 | Sulfated Ash / Residue on Ignition | IP 2.4.14 / USP <281> | Not more than 0.1% w/w | 0.03% w/w | CONFORMS |
| 7 | Related Substances: 4-Aminophenol | HPLC (IP / USP) | Not more than 50 ppm (0.005%) | Less than 10 ppm (Not Detected) | CONFORMS |
| 8 | Related Substances: Any other individual impurity | HPLC (IP / USP) | Not more than 0.10% | 0.02% | CONFORMS |
| 9 | Related Substances: Total Impurities | HPLC (IP / USP) | Not more than 0.50% | 0.06% | CONFORMS |
| 10 | Assay (on Anhydrous Basis) | HPLC Assay (IP / USP) | 99.0% to 101.0% w/w | 99.84% w/w | CONFORMS |
Quality Assurance Final Disposition Statement:
The submitted batch conforms to IP 2022 and USP specifications. Approved and released for formulation manufacturing.
Sandeep Joshi, M.Sc
Senior QC Analyst (Emp: QC-204)
Meaning: "I authored and validated these analytical entries."
14-Oct-2026 14:10:02 IST
Dr. Priyanka Rane
QC Technical Manager (Emp: QC-012)
Meaning: "I have reviewed raw data, chromatography & suitability."
14-Oct-2026 15:45:18 IST
Dr. Vikramaditya Sen
Head - Quality Assurance (Emp: QA-001)
Meaning: "Approved for finished batch release and commercial dispatch."
14-Oct-2026 16:32:00 IST
How ExactLIMS Eliminates FDA 483 Observations in Pharma QC Labs
Data integrity issues—such as testing into compliance, unapproved re-tests, and using out-of-calibration balances—account for over 60% of FDA 483 inspection citations. ExactLIMS replaces vulnerable manual spreadsheets with deterministic enforcement.
Hardware Calibration & Daily Verification Guard
Daily standard weight verification for analytical balances and pH meter slope checks are mandatory before any sample sequence can be initiated.
Formal Out-of-Specification (OOS) Investigation Workflows
Any result exceeding pharmacopeial acceptance criteria automatically triggers an OOS Phase I laboratory investigation checklist before re-testing can begin.
Chromatography Data System (CDS) Direct Interfacing
Connect Waters Empower, Agilent OpenLab, and Shimadzu LabSolutions directly. HPLC retention times, peak areas, and resolution factors flow directly into the audit packet.
Waters Alliance HPLC-02
OQ/PQ Validated | Cal: 20-Dec-2026
Mettler Toledo Microbalance-01
Daily Cal Std: 100mg ± 0.05mg (Passed)
Shimadzu GC-MS-03
Annual Calibration Expired: 12-Oct-2026
Frequently Asked Questions About ExactLIMS for Pharma & Chemical Labs
Detailed answers regarding 21 CFR Part 11 electronic records, instrument lockout enforcement, raw material quarantine, and CDS integrations.
Ready to Bring Audit Confidence to Your Pharma & Chemical Laboratory?
From active pharmaceutical ingredients to high-purity industrial solvents, eliminate data integrity vulnerabilities. Empower your QC analysts and QA managers with automated monographs, calibration lockout guards, and dual-witness electronic signatures.