Analytical Lot Link — Connecting Lab Results to the Lots Used in Manufacturing

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated November 2025 • LIMS, Tests & Laboratory Analyses, Batch-Specific Potency, eBMR • Data Flow, Assay, Traceability, GMP

An analytical lot link is the controlled, system-level connection between a material lot (or intermediate batch) and the specific analytical results that define its quality attributes – potency, assay, LOD, % solids, identity, purity and more. Instead of potency and test data living only inside LIMS reports or on certificates of analysis, the analytical lot link ties those results directly to the lot master data and the electronic batch record (eBMR). It is the backbone that allows batch-specific potency, potency adjustment factors, corrected active content and concentration-adjusted charges to be based on traceable, reviewable lab data instead of manual data entry or assumptions.

“If you cannot show which exact test result drove a dosing decision for a lot, you do not truly control potency. The analytical lot link closes that gap.”

1) What Is an Analytical Lot Link?

An analytical lot link is more than just a shared ID number between systems. It is a set of logical relationships that state, in effect:

• “These are the laboratory tests and results that define the quality attributes of this lot or intermediate”; and
• “These are the batch records and operations where that lot and its test results were used.”

The link usually connects three layers:

• the lab layer (sample, test, result) in LIMS or QC systems;
• the material layer (lot, batch, intermediate) in ERP/MES; and
• the execution layer (additions, transfers, charges) in MES/eBMR.

When implemented properly, the analytical lot link allows you to click from a batch step that used “API Lot 12345” straight to the actual assay, LOD and solids results that were used to calculate its batch-specific potency – and vice versa. It turns paper trails and tribal knowledge into a structured, queryable web of relationships across systems.

2) Why the Analytical Lot Link Matters for GMP

From a GMP perspective, potency and key quality attributes must be attributable, traceable and reproducible. When inspectors ask:

• “Which test results did you use to release this lot?”
• “Which potency value did you use when calculating dose for this batch?”
• “Where did this corrected potency come from, and who approved it?”

the analytical lot link is what allows you to answer with evidence rather than with narrative explanations. Without it, organisations often rely on manual transcription of lab values into ERP or MES, local spreadsheets and disconnected PDFs. These patterns are fragile, hard to audit and prone to data-integrity issues.

A robust analytical lot link ensures that the potency value in MES or ERP can always be traced back to an approved test in LIMS, complete with method, version, analyst and instrument. It also ensures that any changes to that potency (for example, after re-test or stability re-evaluation) are tracked with audit trails and change control, not silently overwritten in master data.

3) Key Elements of an Analytical Lot Link

A practical analytical lot link typically involves these anchors:

• Lot identifier: the unique lot / batch number used in ERP/MES and on labels.
• Sample and test IDs: the sample IDs, test numbers and result records in LIMS.
• Result set: the specific set of tests that feed potency and quality attributes (assay, LOD, identity, purity, % solids, titer).
• Effective date / version: when those results became effective for that lot and, if re-tested, how versions are sequenced.
• Usage links: references in eBMR and inventory transactions showing where the lot was consumed.

Under the hood, the link may be implemented via foreign keys in databases, interface messages (e.g. XML/JSON from LIMS into MES/ERP) or a dedicated “quality attributes” table keyed by lot number and test type. The important thing is that the relationship is explicit and system-enforced, not inferred from file names, spreadsheet tabs or hand-written notes on printed CoAs.

4) Linkage with LIMS and Tests & Laboratory Analyses

The starting point for the analytical lot link is the lab. Test results live initially in LIMS or related QC systems. The tests & laboratory analyses process typically includes:

• sample registration (including lot and location information);
• assignment of test plans (assay, LOD, identity, purity, solids, pH, etc.);
• execution and recording of results; and
• review and approval by QC and QA.

Once approved, relevant results are published to ERP/MES as “quality attributes” of the lot. The analytical lot link ensures that this publication is not just a blind push of numbers but a structured mapping: lot X uses assay result Y, LOD result Z, solids result W, and so on. If results are re-opened or corrected in LIMS, the link ensures that updated values are versioned and propagated correctly, with a full audit trail of what changed and why.

For in-process intermediates sampled via in-process assay gates, the same pattern applies: the intermediate’s “lot” in MES is linked to its in-process sample and test results in LIMS. The gate then checks that the analytical lot link exists, is approved and meets limits before allowing the process to continue.

5) Feeding Batch-Specific Potency, LOD and % Solids

The analytical lot link is the bridge through which lab data become batch-specific potency. When a potency-managed lot is created or released, the system needs to know:

• its potency (e.g. % assay on a defined potency basis);
• its moisture or LOD, for LOD adjustment and dry-basis conversions;
• its % solids basis and density, for liquids and slurries;
• any other potency-related attributes (titer, units/mL, activity units).

The analytical lot link ties these results to the lot and informs the calculations that derive a single potency value used in potency adjustment factors, corrected active content, concentration-adjusted charges and potency-normalised yields. Without that link, the system either cannot perform potency-aware calculations, or it relies on manually typed values that are difficult to defend during investigations and audits.

In a V5-style MES, the analytical lot link effectively underpins all potency-driven features: if the link is missing or incomplete, the system can flag the lot as not potency-ready, preventing its use in potency-adjusted batching steps until the underlying data issues are resolved.

6) Impact on Concentration-Adjusted Charges and Test-Driven Setpoints

For liquid and semi-solid ingredients controlled via concentration-adjusted charges, the analytical lot link carries concentration-defining data (assay, solids, density) from LIMS to MES. When an in-process assay gate is passed, the updated potency is linked to the intermediate, and any downstream setpoints governed by test-driven setpoint adjustment can be recalculated automatically.

For example:

• a concentrate’s solids and assay change following concentration or evaporation;
• LIMS publishes new results tied to the intermediate’s lot via the analytical lot link;
• MES updates batch-specific potency, recalculates concentration-adjusted charge targets and displays new setpoints to operators; and
• the eBMR shows that these adjustments were driven by specific, traceable test results.

Without this linkage, concentration-aware logic has no reliable anchor; operators might rely on printed lab reports, manual entry and local calculators, which defeats the purpose of a controlled, auditable test-driven control strategy.

7) Role in the Electronic Batch Record (eBMR)

In a modern eBMR, it is not enough to show that certain lots were used. Quality and regulators increasingly expect to see:

• which tests were performed on those lots;
• what the results were, on which basis, with which methods; and
• how those results influenced dosing, adjustments and release decisions.

The analytical lot link enables clickable drill-down from batch steps and materials to source test data. A typical record might show, for each lot used:

• a summary of key attributes (potency, LOD, solids, key impurities);
• a link to the originating LIMS record or a controlled copy of the CoA;
• the effective date/version of results used for the batch; and
• an indication of whether any re-tests or corrections occurred before or after the batch.

This tight integration improves review efficiency, supports deviation and OOS investigations and provides inspectors with an integrated narrative rather than a scavenger hunt across systems and paper. It also aligns with expectations under 21 CFR Part 11 and Annex 11 for integrity and completeness of electronic records.

8) Data Integrity, ALCOA+ and Audit Trails

From a data-integrity standpoint, the analytical lot link is a key enabler of ALCOA+ principles:

• Attributable: potency and quality attributes are attributable to specific tests, analysts and instruments.
• Legible: results and links are clear, structured and easy to interpret across systems.
• Contemporaneous: lab results are recorded and published when the tests are performed, not reconstructed later.
• Original: MES and ERP store references to original test records or controlled copies, not retyped approximations.
• Accurate: data is transferred electronically, with checks and audit trails for changes.

Every time an analytical result that feeds potency is changed, the analytical lot link – and therefore the potency values in MES/ERP – should update in a controlled way. Audit trails must show who changed what, when and why, and impact assessments must evaluate which batches, if any, are affected. This is far easier when the analytical lot link is explicit and system-managed than when potency values are simply keyed into master data without reference to the tests behind them.

9) Design Patterns for Interfaces and Master Data

There are several common design patterns for implementing analytical lot links:

• Push from LIMS: when tests are approved, LIMS sends a structured message (API call, file, message queue) to ERP/MES with lot ID, test IDs and key results. ERP/MES store these against the lot and mark potency attributes as system-populated, not user-editable.
• Pull from MES/ERP: when a lot changes status (e.g. to “awaiting QC” or “ready for release”), MES/ERP query LIMS for approved results matching that lot and update potency attributes via a controlled interface.
• Hub model: a central data hub or quality attributes service stores all test-lot relationships and provides a single source of truth to both LIMS and MES/ERP.

In all patterns, the key is that potency and other batch-calculation-critical attributes are derived from analytical lot links, not typed directly into “Potency (%)” fields by operators or master-data admins. MES may still provide screens to view and annotate these values, but editing them should require appropriate roles, electronic signatures and linkage back to changes in LIMS or the quality attributes hub, all under change control.

10) Use in Investigations, PQR and CPV

A well-implemented analytical lot link makes life much easier for QA, technical and regulatory teams during:

• Investigations: quickly identifying which lots and tests contributed to a suspect batch, and whether any assay, LOD or solids anomalies correlate with deviations or OOS events.
• Product quality reviews (PQR): summarising potency performance, assay variability and lot-to-lot stability across periods, tied to specific analytical data and trends.
• Continued process verification (CPV): analysing active-in vs active-out, potency-normalised yield and the relationship between analytical attributes and process performance.

Without an analytical lot link, these activities often rely on manual data mining, cross-referencing spreadsheets and reconstructing which “assay value” was used when. With the link in place, queries can be run directly against a structured dataset: “show me all batches where this lab method version was used”, or “show me yields by potency decile”, and so on. This supports more robust science- and risk-based oversight of potency and quality attributes over the product lifecycle.

11) Typical Use Cases Across Industries

Analytical lot links are fundamental across regulated and quality-critical sectors:

• Pharmaceuticals and biologics: linking API, intermediate and bulk lot potency, purity, LOD and titer results to lots used in synthesis, purification, formulation and filling.
• Dietary supplements: connecting vitamin, mineral and botanical assay results – often with variable potency and moisture – to lots used in blends and tablet/capsule manufacture.
• Food and beverage: linking enzyme activity, solids and potency tests to lots of concentrates and premixes used in high-volume production.
• Cosmetics and personal care: connecting actives’ assay and stability tests to bulk lots and finished batches where label claims depend on active level.
• Chemicals and speciality materials: linking activity tests and compositional analysis to catalyst and additive lots used in downstream processing.

In each sector, the analytical lot link is a prerequisite for serious potency management. Without it, potency-aware batching features are difficult to validate and defend, and data integrity gaps are almost inevitable when bridging between LIMS and manufacturing systems.

12) Common Pitfalls and Anti-Patterns

When analytical lot links are weak or absent, organisations tend to fall into predictable patterns:

• Manual re-typing: copying assay and LOD values from PDFs or paper CoAs into ERP/MES by hand, inviting transcription errors.
• Spreadsheet islands: calculating batch-specific potency, potency factors and charges in local spreadsheets that are not integrated or validated.
• Ambiguous sources: storing a single “Potency (%)” value for each lot without recording which test, method or basis it came from.
• Silent corrections: changing potency in master data without updating or cross-referencing analytical data or documenting the reasons.
• Fragmented IDs: using different lot identifiers in LIMS, ERP and MES, making it difficult to prove that a given test actually corresponds to the lot used in a batch.

These anti-patterns dramatically increase investigation effort, raise data-integrity concerns and make it harder to implement potency-aware features like in-process assay gates and dynamic, test-driven setpoints. The analytical lot link is the structural fix: once in place, it can gradually replace manual and ad-hoc practices with automated, audit-ready ones.

13) Practical Implementation Steps

To establish analytical lot links in a robust, scalable way, organisations typically:

• agree on a single lot-identifier strategy used consistently across LIMS, ERP and MES;
• catalogue which tests and attributes must be linked to lots (assay, LOD, solids, titer, key impurities);
• define structured interfaces for publishing lab results from LIMS to ERP/MES or to a central quality-attributes hub;
• configure ERP/MES to store analytical attributes against lots as system-populated values, not manually editable fields;
• link potency-aware calculations (batch-specific potency, potency factors, corrected active content, concentration-adjusted charges) explicitly to those attributes;
• update SOPs, training and CSV documentation to describe and validate the new data flows.

Once analytical lot links are in place, they become part of the infrastructure: every new potency-managed ingredient, intermediate or control strategy can reuse the same pattern. Over time, this reduces reliance on manual workarounds, strengthens data integrity and makes potency-aware batching a normal, defensible part of operations rather than a specialist exception.

FAQ

Q1. Is an analytical lot link the same as just matching lot numbers between systems?
No. Matching lot numbers is necessary, but not sufficient. An analytical lot link explicitly associates specific test results, methods and versions with each lot and uses those associations in potency and quality calculations, with full traceability and audit trails.

Q2. Do we need a LIMS to implement analytical lot links?
A LIMS makes implementation easier, but the core concept can be implemented with other QC systems if they can expose structured test results and sample–lot relationships. The key is controlled, electronic data exchange, not a particular product.

Q3. Can operators manually change potency values when an analytical lot link is in place?
In a robust design, potency values derived from analytical lot links should not be freely editable. Any corrections must be driven by changes in the underlying analytical data, controlled via change control and recorded with audit trails.

Q4. How does the analytical lot link help during an OOS investigation?
It allows investigators to see exactly which tests, methods and versions fed the potency used in dosing, and to identify other batches or lots that relied on the same analytical data. This speeds impact assessment and helps distinguish analytical issues from true process or stability problems.

Q5. What is a practical first step toward implementing analytical lot links?
Start with one high-impact potency-managed material. Ensure lot IDs are consistent across LIMS and MES/ERP, define which tests feed potency, build a simple interface to publish results to MES, and configure MES to treat those results as the sole source for batch-specific potency. Once proven, apply the same pattern to other materials.

Related Reading
• Lab & Data: LIMS | Tests & Laboratory Analyses | Data Integrity | Audit Trail (GxP)
• Potency & Batching: Batch-Specific Potency | Potency Basis | Potency Adjustment Factor | Corrected Active Content | Concentration-Adjusted Charge
• Gates, Yield & Records: In-Process Assay Gate | Potency-Normalised Yield | Electronic Batch Record (eBMR) | Computer System Validation (CSV)