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LIMS moduleVersioned · e-signed

Specification management software for pharma — one approved version, everywhere.

Specification management software in Swat iQua Suite keeps product and material specifications — acceptance criteria and test method trees — under versioned, e-signed control, and feeds the approved version to every test.

  • Draft → In Review → Pending Approval → Approved
  • Immutable snapshot on approval
  • Alert and action limits per test
  • Shared across sites, forked for local changes
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Specification lifecycle

Every specification earns its approval.

Specifications follow a fixed approval path with three different people. Editing an approved specification sends the new version back through review.

  1. DraftPreparer

    Drafted

    Subject (product, material or other), tests, methods and limits entered.

    Draft

  2. In ReviewReviewer ≠ preparer

    Reviewed

    A second person reviews and signs with name, designation and time.

    In review

  3. Pending ApprovalApprover ≠ both

    Approved

    An independent approver e-signs; the version snapshot is frozen.

    Approved

  4. SharedOptional

    Shared across sites

    Read-only at other sites, with a fork for genuine local changes.

    Effective

Major changes create a new version (v+1 r0); minor changes create a new revision (v r+1) — the history stays readable.

Key capabilities

Test specifications and STPs under real control.

  • Immutable approved versions

    Approval freezes a snapshot that cannot be changed. Version history shows exactly what applied, and when.

  • E-signed review and approval

    The signature records name, designation at the time of signing and timestamp, with password re-authentication.

  • Three-person approval

    Reviewer ≠ preparer; approver ≠ preparer and ≠ reviewer. No administrator bypass.

  • Method trees with copy

    Methods and child methods for each test, copied between specifications to save setup time. Identity tests flagged.

  • Alert and action limits

    Set both levels per test, so trends can be caught before a result goes out of specification.

  • Controlled print

    Controlled copies with a reprint counter, and a watermarked work copy before approval.

How it works

One specification drives the whole lab.

In Swat iQua Suite the approved specification is not a PDF on a shared drive — it is the data every test is checked against.

Pharmacopoeia limits, entered once

Each specification has a typed subject — a product, a material or another item — and a tree of tests and methods. Acceptance criteria, including pharmacopoeia limits where they apply, are entered once with alert and action limits. Child methods and copy let you build a family of similar specifications without retyping.

Frozen where it matters

When a sample is registered in Sample & Testing Management, the effective specification version is frozen for that sample, and the specification is locked while those samples are open. In-house QC testing freezes the limits when a test is assigned. Either way, a later change to the specification never rewrites a past verdict.

Global clients, local labs

Multi-site organisations can share an approved specification across sites. Other sites see it read-only; if a site genuinely needs a local variant, it forks a copy that follows its own approval path. Specifications also feed stability studies, client sample requests and the released-results history report.

Regulations

Designed to support controlled specifications.

  • 21 CFR Part 11

    Signature manifestation as described in 21 CFR 11.50 — name, designation at signing, meaning and time — on review and approval.

    21 CFR Part 11

  • US FDA cGMP

    Written, approved specifications for components and products, with every change reviewed and recorded.

    FDA cGMP

  • Revised Schedule M

    Approved specifications and test procedures available to every QC analyst, in one controlled version.

    Revised Schedule M

Keep exploring

Related LIMS pages

FAQ

Frequently asked questions

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

What does specification management software do?

It holds your approved product and material specifications — tests, methods and acceptance limits — under version control, and makes the approved version the one every test is checked against. Swat iQua Suite adds e-signed review and approval and a full version history.

How are specification versions numbered?

A major change creates a new version (v+1 r0) and a minor change a new revision of the same version (v r+1). Each approved version is frozen and stays in the history.

Can one specification be used at several sites?

Yes. An approved specification can be shared across sites, read-only for the others. A site that needs a local change forks its own copy, which goes through its own approval.

Does changing a specification affect results already reported?

No. Samples freeze the specification version at registration and in-house QC freezes limits at test assignment, so past verdicts are never rewritten.

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