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Pharma LIMSSample → result → CoA

Pharma LIMS for QC laboratories — every result reviewed before it counts.

Swat iQua Suite is a pharma LIMS built for QC laboratories in the pharmaceutical industry: samples, specifications, testing, stability, environmental monitoring and instruments on one cloud platform — with second-person review, e-signatures and a complete audit trail designed to comply with 21 CFR Part 11.

  • Specification version frozen at registration
  • Controlled Excel/CSV result import
  • Analyst ≠ reviewer ≠ approver
  • CoA released to clients through a portal
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Scientist pipetting a sample into a flask in a QC laboratory
10+
years of pharma expertise
85+
integrated modules
3
e-signature levels
1–3
months to go-live

2-minute product tour

Real screens, real records. See the lab in action.

  1. QC sample MS/2026/00054 linked to its batch, with seven assigned tests all completed and approved

    Step 1 of 57 tests approved

    One sample, every test reviewed

    MS/2026/00054 is a finished-product sample with seven tests. The sample is complete only when every test result has been reviewed and approved.

    1. Linked to its batch
    2. Second-person review
    3. Each test tracked
  2. Assay test result of 99.4 evaluated within the specification limit of 95 to 105, with original flag and entry time

    Step 2 of 5Within limits

    Results checked against the limit

    The assay result is evaluated against its specification limit as it is entered. A correction never overwrites: the original value stays on record.

    1. Specification limit
    2. Evaluated on entry
    3. Corrections keep the original
  3. OOS investigation record with the failing result, impact assessment and level 1 investigation reviewed and approved

    Step 3 of 5Finalised & locked

    Out of specification, investigated and locked

    An assay of 93.1 % against 95.0–105.0 % opened OOS/2026/0001. The phase I investigation is reviewed by the QC manager and approved by Head QA, then the record is finalised and locked.

    1. Finalised & locked
    2. The result and its limit
    3. Reviewed and approved
  4. Instrument record for a platform balance with maintenance and calibration schedule and qualified-for-use status

    Step 4 of 5Qualified

    Instruments qualified before use

    Each instrument carries its maintenance and calibration schedule and its qualification status. A balance that is not calibrated cannot be used at dispensing.

    1. Calibration due soon
    2. Qualified for use
    3. Critical instrument
  5. Stability study STB/0001 with product, batch, pull schedule, storage condition and approval

    Step 5 of 5Protocol approved

    Stability studies on schedule

    STB/0001 is a 36-month long-term study with its pull schedule and reserved samples. The protocol was reviewed by the QC manager and approved by Head QA.

    1. Next pull date
    2. Approved, with name and time
    3. Trend & shelf-life

Real product footage

Watch a result reviewed by a second person.

Why a pharma LIMS

What a pharma LIMS has to get right — before an inspector asks.

A laboratory information management system for pharma is not a sample spreadsheet with a login. It has to prove who did what, against which specification, on which instrument — and that nobody changed the answer afterwards.

From registration to Certificate of Analysis

In Swat iQua Suite every sample follows one controlled path: registered, routed to the right lab area, tested, reviewed, approved and released with a Certificate of Analysis. Samples can be registered by the lab, converted from an approved client sample request, or created by a stability pull. Routing by drug class sends microbiology, controlled and routine work to the right GMP location without anyone retyping it.

The specification version in force is frozen onto the sample at registration, and the specification is locked while samples against it are still open. If the specification is revised next month, past results keep the limits they were judged against — exactly what an inspector will check.

Results that cannot quietly change

Once an analyst submits results they are locked. A reviewer can send the sample back for re-entry, but the first entry and the reason for every change stay in the audit trail. Segregation of duties is enforced by the server: the reviewer cannot be the analyst, and the approver cannot be either of them. There is no administrator bypass on that chain, and e-signatures can be required at send-for-approval and at approval.

  • Worksheets, sample labels and the CoA printed from the approved record, each enabled separately
  • Working-day turnaround metrics for every sample
  • An optional block on using an instrument that is out of calibration
  • Reagents, standards, columns and consumables tracked with expiry status and controlled labels

Built for manufacturer QC and contract testing

Manufacturers use in-house QC testing for raw material, in-process, finished product, stability, water and microbiology samples, with limits frozen at test assignment and every result classified as within limits or OOS. Contract testing laboratories add the client portal, where clients submit requests and download the CoA only after it is released. Both run on the same specifications, instruments and audit trail.

Swat iQua Suite is designed to comply with 21 CFR Part 11 and EU GMP Annex 11, following ALCOA+ data-integrity principles. Validation of each installation remains the regulated company’s responsibility — we support it.

LIMS modules

Seven modules. One QC laboratory.

License the modules your lab needs today and add the rest later — they share the same samples, specifications, users and audit trail.

  • Sample & Testing Management

    Register, route, test, review and approve samples — with reagent and standard inventory.

    Sample management

  • Specification Management

    Versioned specifications with acceptance criteria, alert and action limits and method trees.

    Specifications

  • Stability Study Management

    Server-computed pull schedules per storage condition; each internal pull creates its lab sample.

    Stability studies

  • Environmental Monitoring

    Cleanrooms, monitoring points, versioned alert and action limits and gowning qualification.

    Environmental monitoring

  • Instrument Calibration & Maintenance

    Calibration and maintenance records that can be added to but never edited, with due reminders.

    Instrument calibration

  • Contract Lab Client Portal

    Client sample requests, released results and CoAs — each client sees only its own records.

    Client portal

  • In-House QC Testing (RM / IP / FP)

    Raw material, in-process and finished product testing driven by the effective specification.

    QC testing

Controlled result import

From instrument file to approved result.

Instrument and spreadsheet results enter the GMP record only through approved import profiles or the secure REST API. Nothing is saved at preview, and the original file is kept as raw data — without a long instrument-integration project.

  1. File.xlsx · .csv

    Template and preview

    The file is checked against an approved import profile; the preview saves nothing.

    Preview

  2. CommitReason recorded

    Committed with a reason

    The analyst commits the values with a reason — or rejects the file.

    Committed

  3. Raw dataSHA-256

    Original file preserved

    Source records stored with a SHA-256 hash; downloads are controlled and logged.

    Preserved

  4. ReviewSecond person

    Reviewed and approved

    Values count only after review and approval by different people.

    Approved

ALCOA+ in practice — original, attributable and available for every imported value.

Stability studies

Stability studies that schedule themselves.

Pull dates are calculated by the server from time zero for each storage condition, with pull windows. Pulls are blocked until the protocol is approved, a late pull is allowed but flagged, and every internal pull creates its testing sample automatically.

  • ICH storage conditions — four seeded, with storage locations occupied and freed automatically.
  • “My pulls” worklist — plus a daily reminder digest for due pulls.
  • ICH Q1E trend and shelf-life report — regression on screen, in PDF and in Excel.
  • Escalation — a failure or out-of-trend result can raise a CAPA.
Stability study management
QC analysts working at laboratory instruments

Around the bench

Everything else a QC lab needs to stay inspection-ready.

  • One audit trail for the whole lab

    Every registration, result, review and print — old value, new value, user, time and reason — cross-referenced to the sample, specification and instrument.

  • Lab labels

    Sample, instrument, lab-material and stability labels printed to industrial label printers.

  • Second-person raw-data review

    An independent reviewer checks raw data; a finding raises a deviation.

  • Nothing slips

    Daily digests for overdue testing, instrument due dates and stability pulls.

  • Client portal

    Requests in, released CoAs out — each client sees only its own company’s records.

  • REST API

    A versioned /api/v1 with token authentication, specification and testing resources, and instrument agent tokens for controlled uploads.

21 CFR Part 11 LIMS

How the LIMS controls map to Part 11 and Annex 11.

Regulators expect the laboratory record to be complete, consistent and attributable. These are the controls Swat iQua Suite puts behind that expectation.

Electronic records — 21 CFR 11.10

21 CFR 11.10 asks for controls such as limited system access, secure, computer-generated, time-stamped audit trails, operational and authority checks, and accurate copies of records for inspection. In the LIMS this means role-based permissions per site, an audit-trail entry written in the same transaction as every change with a mandatory reason, server-enforced workflow order, and PDF and Excel exports of results and audit trails that are themselves logged.

Electronic signatures — 21 CFR 11.50 and 11.200

Signatures re-authenticate the user with their password — or password plus a one-time code where configured — and record the signer’s name, designation at the time of signing and the time. Specifications are signed at review and approval; samples can require a signature at send-for-approval and at approval.

EU GMP Annex 11 and data integrity

Annex 11 expects computerised systems to be validated, risk-assessed and to keep audit trails that are regularly reviewed. Periodic, risk-based audit-trail review in Swat iQua Suite flags deletions, privileged changes and changes after approval, and the data-integrity themes inspectors return to — original records, second-person review, no silent overwriting — are built into the testing workflow rather than left to procedure.

Five questions to ask any LIMS vendor

  1. Can a past result be traced to the exact specification version it was judged against?
  2. Can one person enter, review and approve the same result?
  3. How do instrument results get in — and is the original file kept?
  4. Can clients or other sites see only what they should?
  5. How long until the lab is live, and who migrates the history?

Swat iQua Suite answers each of these in the product, not in an SOP. Typical go-live is 1–3 months, including structured migration of your existing specifications and records.

Designed to comply with

Customer stories

Ten years on, they would choose Swat iQua Suite again.

“Ten years on, we would choose it again.”

We moved our QC LIMS onto SwatTech in 2016 and have never looked back. Every specification, result and calibration is one search away, and every change explains itself. When inspectors arrive, we don’t prepare — we simply open the system.

ARC Pharma UK LimitedUnited Kingdom · QC laboratory, since 2016

“Audits are something we welcome now.”

In contract testing, our reputation rides on every result we sign. A second-person review on every result, a complete audit trail and a client portal that delivers reports and CoAs on time have turned audits from something we braced for into something we welcome.

Lunar Labs LimitedUnited Kingdom · QC laboratory

“Any batch, traced in one click.”

In API manufacturing, traceability is everything. Today we follow any batch back to its raw-material lots and forward to every shipment in seconds. Revised Schedule M no longer feels like a deadline — it feels like the way we already work.

Norvium Healthcare Pvt. Ltd.India · API manufacturing

Keep exploring

Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is a pharma LIMS?

A laboratory information management system built for GMP work: it controls samples, specifications, testing, review and release, and keeps the evidence regulators expect — audit trail, e-signatures and segregation of duties. Swat iQua Suite adds stability, environmental monitoring, instruments and a client portal on the same platform.

Is the Swat iQua Suite LIMS 21 CFR Part 11 compliant?

Software on its own cannot be “Part 11 compliant” — compliance depends on how each installation is validated and used. Swat iQua Suite is designed to comply with 21 CFR Part 11 and EU GMP Annex 11, with a complete audit trail, password or password-plus-code e-signatures, segregation of duties and role-based access. We support your validation.

Does the LIMS connect to HPLC and other instruments?

Results enter through approved Excel/CSV import profiles or the secure REST API. The original file is stored as raw data with a SHA-256 hash, and every value is reviewed before it counts — data integrity from day one, without a long instrument-integration project.

Can contract testing labs use it?

Yes. The client portal lets client companies submit sample requests, which your team reviews and converts into samples. Clients see only their own records and can download the CoA only after it is released.

Is it a cloud LIMS?

Yes. Swat iQua Suite is cloud-hosted: no servers to buy or maintain, encrypted connections, scheduled backups and your data stored in your chosen region.

How long does a LIMS implementation take?

Typical go-live is 1–3 months, depending on the modules and sites in scope. We map your processes, configure the lab, migrate your specifications and records, and train your analysts and reviewers.

Ready to see Swat iQua Suite in action?

Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.

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