MD-LIMS by Radhey Radhey Enterprises

MD-LIMS — Molecular Diagnostics Laboratory Information Management System

Radhey Radhey Enterprises, #2, Shree Radhey Complex, Science Market, Ambala Cantt, Haryana 133001 · 0171 4525101 · +91 87084 10052 · software@labscope.co.in

GSTIN 06ABBFR4715K1Z5 · Udyam UDYAM-HR-01-0032974 (Micro, Partnership) · GeM Seller ID U3N2240012054436 · Drug Licence (MD-42) HR/AMB/MD42/2024/000014

Capability list

Capabilities

What MD-LIMS does, grouped by area of the laboratory’s work. Each item has a reference number that can be quoted in correspondence and in a compliance statement.

SM Sample management

  1. SM-01Sample reception with a unique accession number and barcode. Acceptance or rejection is recorded with a reason.
  2. SM-02Aliquots and derivatives are linked to their parent sample.
  3. SM-03Storage is recorded down to freezer, shelf, rack, box and position, with location history and thaw count. Removing a sample from storage requires a recorded reason.
  4. SM-04The complete chain of custody of a sample can be read on one screen.
Illustration with sample data, not a capture of the software. MD-LIMS sample tracking screen showing one sample’s reception, aliquots, storage locations and chain of custody.
Illustration Sample tracking — the whole life of a sample on one screen

TR Testing and results

  1. TR-01Methods are configured per laboratory, with versions. Each method defines its result fields, units and decimals.
  2. TR-02Laboratory-defined calculations. The software computes derived values, such as delta Ct, from the fields entered, and keeps the inputs.
  3. TR-03Reference ranges and critical values are flagged at entry.
  4. TR-04Runs and plate layouts. The instrument and the reagent lots used are recorded against the run.
  5. TR-05Results are reviewed by a person other than the one who entered them, who accepts, rejects or asks for a repeat, with a reason.
Illustration with sample data, not a capture of the software. MD-LIMS run screen showing a plate layout with sample wells and the control well marked.
Illustration A run on the plate, with its control

QC Quality control

  1. QC-01Westgard multi-rule QC: 1-3s, 1-2s, 2-2s, R-4s, 4-1s and 10-x.
  2. QC-02A failed control holds the run automatically. Only an authorised person may release the hold, and the reason is recorded.
  3. QC-03Levey-Jennings charts with the ±1, ±2 and ±3 SD bands.
  4. QC-04Turnaround time targets per method, with a list of breaches.
Illustration with sample data, not a capture of the software. MD-LIMS quality control screen showing a control that failed a Westgard rule and the run placed on hold.
Illustration A control outside the limits, and the run held
Illustration with sample data, not a capture of the software. MD-LIMS Levey-Jennings chart for one control target with the ±1, ±2 and ±3 SD bands.
Illustration Levey-Jennings chart for a control target

RS Reporting and signatures

  1. RS-01Multi-level review and approval, configured to the institute’s own policy.
  2. RS-02Every signature requires the password to be entered again at the moment of signing, and is bound to a SHA-256 hash of exactly the content signed.
  3. RS-03Any change after signature produces a new version with its own hash. Nothing is overwritten and nothing is deleted.
  4. RS-04Printable reports, and secure, time-limited, audited delivery links.
  5. RS-05Report formats are built to the institute’s own format during implementation.
Illustration with sample data, not a capture of the software. MD-LIMS released report showing its chain of signatures and the SHA-256 hash of the signed content.
Illustration A released report with its signature chain and content hash

IN Instruments

  1. IN-01Instrument register with calibration and preventive-maintenance schedules. An overdue instrument can be blocked from use.
  2. IN-02Instrument interfacing through a gateway that speaks ASTM E1381/E1394 and HL7 v2 over MLLP, and collects result files from a watch folder or network storage.
  3. IN-03The driver for each instrument is built from that instrument’s own output files during the site survey. Drivers do not exist in advance for every instrument.
  4. IN-04Temperature monitoring of freezers and cold rooms through sensor integration, configured at site.

RG Reagents and stock

  1. RG-01Reagent lots are recorded with expiry. A lot arrives in quarantine and cannot be consumed until it is released.
  2. RG-02Alerts for expiring, expired and low stock.
  3. RG-03Consumption is traced to the results it produced, so a recalled lot can be followed.

PA People and access

  1. PA-01Roles and permissions per module and per method.
  2. PA-02Authorisation per method is enforced at entry, review and signature. A person not authorised for a method cannot run it.
  3. PA-03Training and competence records, with competence that lapses.
  4. PA-04Proxy login records both people. There is no signing under proxy.
  5. PA-05The system administrator holds no laboratory permission and cannot read patient results.

RD Referring departments

  1. RD-01A portal where a referring ward or department books tests and reads only its own released reports.

DP Data protection

  1. DP-01PostgreSQL with row-level security enforced by the database itself, not by query filters. The account the application connects with owns nothing and cannot bypass it.
  2. DP-02An append-only, hash-chained audit trail of every action.
  3. DP-03A nightly backup that restores itself into a scratch database and re-verifies the audit chain before the copy is kept.

This list describes the software as supplied. Institute-specific report formats, instrument drivers and temperature sensors are built or configured during implementation, as described on the Deployment page.