Quality Control — LIMS
Specifications, methods, worksheets, results and the certificate at the end
A laboratory information system is not a module you can improvise. It has to hold the pharmacopoeial specification, the method that tests against it, the worksheet the analyst fills, the calculation that produces the result, and the review chain that approves it. DeepPharmaERP includes a full LIMS rather than a quality checklist.
What Quality Control — LIMS covers
Specifications and methods
- Pharmacopoeia master with test definitions, groups and limits
- Specification for raw material, packing material, in-process, WIP and finished goods
- Multi-stage review — prepared, verified, QA reviewed, RA reviewed, approved
- MOA, STP, raw data sheet, formulae and analytical worksheet definitions
Sampling and testing
- Sampling plan with container selection and AR number generation
- Sample allocation to analyst, with workload visibility
- Analytical worksheet generation per sample and test group
- Test result entry with formula-driven calculation and limit checking
- QC outsourcing workflow for tests sent to an external laboratory
Stability and instruments
- Real-time and accelerated stability with protocol, condition and time-point scheduling
- Chamber management and pull-point reminders
- Instrument usage log bound to the analyst, sample and method
Output
- Certificate of analysis for RM, PM, WIP, FG and miscellaneous samples
- Status labels — under test, sampled, approved, rejected, control sample, working standard
- Provisional release, approval and rejection registers
What the system notices for you
Suggestions only. Nothing here signs, approves or dispositions anything — a qualified person decides and the audit trail records who. Every model shows the data behind its suggestion, and every feature can be switched off per site.
OOS triage
Compares an out-of-specification result against instrument history, analyst pattern and prior lots to suggest whether it looks like a laboratory error or a genuine product issue.
Stability trend forecasting
Projects whether a product will hold specification to the end of its claimed shelf life from the time points collected so far.
Method deviation detection
Notices when execution of a method drifts from its normal pattern across analysts and instruments.
Equipment this module connects to
Read-only by default, validated as part of the system, and buffered locally so a network drop never loses a reading.
| HPLC, GC and UV systems | Chromatography results pulled from the data system rather than retyped. |
| Analytical balances | Weight capture direct to the worksheet. |
| Dissolution and Karl Fischer apparatus | Instrument output bound to the sample and AR number. |
| Stability chambers | Condition logging and excursion alerts against the stability protocol. |
Quality Control — LIMS — common questions
Does the LIMS handle stability studies?
Yes — real-time and accelerated, with protocol, storage condition, time-point scheduling, chamber assignment and pull reminders. Results roll into trend analysis and the APQR.
Can results come directly from instruments?
Where a validated interface exists, yes. Chromatography data systems, balances, dissolution apparatus and Karl Fischer titrators can write into the analytical worksheet, which removes the transcription step that most data integrity findings come down to.
Works with
Every module shares one database, so nothing below is an integration — it is the same record seen from a different desk.
Quality Assurance — QMS
Deviation, change, CAPA, complaint, audit and training in one system
Read more COCosting
What the batch actually cost, not what the standard said
Read more EQEquipment Maintenance
Calibration status that actually stops the batch
Read more SDSales & Distribution
Order to dispatch, with batch and expiry all the way through
Read moreSee it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.