Quality control and quality assurance

Quality built into the batch. Ready for the auditor.

Electronic batch records with second-person verification, checklists on a phone, specs and tests on every lot, your own COAs, deviations and CAPA with the flows you define, and compliance maps that read your live records instead of a binder.

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app.innersol.io/batches/B-0480/record
Batch record B-0480Immune Elderberry Gummies · Lot L-0481 · Step 6 of 14
In progress
✓Line clearance confirmed, previous product removedJ. Baker 7:42
✓Weigh Vitamin C (ascorbic acid), target 13.08 kg13.10 kg
6Cook to 112 °C, hold 4 min, record the reading111.6 °C
7Deposit, verify piece weight against the spec2.80 to 3.20 g
Sign this step
Jon Baker
••••
Performed
SignVerifier: Mira Patel (QC) signs second
Open a deviation from this stepAttach photo
123
1

Targets on the stepInstruction, target range and recorded value together. Out of range turns amber.

2

Two signaturesTyped name, PIN and the meaning of the signature. A second person verifies the steps you mark.

3

Deviation from the stepOpens with the batch, the lot and the step already filled in.

84sections of 21 CFR Part 111 mapped to live records, each one Compliant, Gap found or No evidence
2signatures on every critical step: the person who did it and the person who checked it
1 clickfrom a failed test to a deviation, a CAPA or a supplier corrective action request
0binders to carry into the audit room
Checklists on a phone

GMP checklists done where the work is.

Daily, weekly and per-batch checklists run on a phone or a tablet. Innersol creates the runs when they are due, asks for a photo where you want one, and turns a missed run red on Home before the day is over.

  • Line clearance, sanitation, pest control, temperature logs, pre-op and post-op walks.
  • Pass, fail or a value per line, a photo or a note where the checklist asks for one.
  • A failed line opens a deviation with the checklist and the line attached.
  • Due runs on the sidebar badge, overdue ones in Needs attention and on the quality feed.
app.innersol.io/checklists
6Due today
4Done
1Overdue
ChecklistWhenStatus
Pre-op walk, Line 2Daily 6:30Done
Cook room temperature logEvery 2 hDue 10:00
Pest control stationsWeeklyOverdue
Allergen changeoverPer batchWaiting
Pre-op walk, Line 2
PassFailN/A
Floor drains clean and covered
PassFailN/A
No product from the previous run
PassFailN/A
Photo attached · deviation openedFinish and sign
12
1

Fail opens a deviationWith the photo, the line and the time. Nobody writes it up later.

2

Runs create themselvesDaily, every two hours, weekly or per batch. Overdue goes red on Home.

Electronic batch records

A batch record that signs itself into the audit trail.

Every manufacturing order carries the steps of its production process: the instruction, the target, the recorded value, who did it and who verified it. Signatures are a typed name, a PIN and a meaning, linked to the record and hashed.

  • Second-person verification on the steps you mark, with the verifier's own signature.
  • Weights against the batch sheet, readings against a range, out of range flagged before the signature.
  • Materials and lots consumed per step, so traceability is a by-product of doing the work.
  • The finished record prints as one PDF with every signature, photo and deviation on it.
app.innersol.io/batches/B-0480/history
Record historyB-0480 · 31 entries · exported to PDF on release
Complete
TimeWhatWhoSignature
07:42Step 1 performed: line clearanceJon BakerPerformed
07:44Step 1 verifiedMira PatelVerified
08:10Step 2 weighed 13.10 kg of lot M-2219 (target 13.08)Jon BakerPerformed
09:05Step 6 reading 111.6 °C, below 112. Deviation DEV-0027 openedJon BakerDeviation
09:20DEV-0027 disposition: re-cook 2 min, QA approvedMira PatelQA
Print batch record PDFExport audit trail
12
1

The deviation is in the recordOpened from the step, dispositioned by QA, printed with the batch.

2

Meaning on every signaturePerformed, Verified, Reviewed, Approved. Hashed and linked to the record.

Specs, tests and lot release

Nothing ships before QC says so.

Specifications live on the product and on each material. Tests are entered against them, results land in or out of spec, and the lot stays on hold until the release is signed. The COA is generated from the results you entered, with your logo and the QC signature.

  • Specs per product and per material: identity, assay, micro, heavy metals, physical attributes, with limits.
  • Pending tests hold the release. Follow-up rules can hold it too, for example until the outside lab results are attached.
  • Lot release is a signature with a meaning. A Super Admin can release anyway, and the record says so.
  • Retains logged per lot, with the location and the retest date.
app.innersol.io/lots/L-0481/release
Lot L-0481Immune Elderberry Gummies · 248,600 pieces · Northlake Wellness
On hold, 1 test pending
TestSpecResult
Vitamin C assay90 to 120%104%Pass
Zinc assay90 to 120%98%Pass
Total plate count<3,000 cfu/g<100Pass
Heavy metals (outside lab)Pb <0.5 ppmResults due Nov 6Pending
Certificate of Analysis
Lot L-0481 · Best by 11/2028
Draft
Vitamin C104% of claim
Zinc98% of claim
Total plate count<100 cfu/g
Leadpending
QC release signature
waiting
Release lotAttach lab resultsLog a retain
12
1

Pending holds the releaseThe outside lab's results are a follow-up task. Attach them and the button wakes up.

2

Your own COABuilt from the results you entered, signed by QC, sent to the customer from the lot.

Deviations, CAPA and suppliers

Event flows you define, followed every time.

Deviations, non-conformances, CAPAs, out-of-spec results, supplier issues and complaints each follow a flow of steps you can edit: what must be filled in, who signs, and how many days each step gets. Innersol enforces the order and names what is missing.

  • Five whys, root cause category, containment, corrective and preventive actions, effectiveness check.
  • Escalate to a supplier corrective action request in one click, e-mailed with the printed form, chased until the reply is verified.
  • An impact assessment lists every material, lot, formula, open order, batch and customer the problem can touch.
  • Supplier scores drop with open and late requests, and the supplier page shows why.
app.innersol.io/quality/events/CAPA-0012
CAPA-0012Low assay on citrate lots from Altura Ingredients · opened from OOS-0004
Step 4 of 7
✓Describe and classifyMajor · M. Patel
✓Containment: hold the three lotsSigned QA
✓Root cause: five whysSupplier process change
4Corrective actions and ownersDue in 3 days
5Supplier corrective action requestSCAR-0003 sent
Impact assessment IMP-0009
3 material lots in stock2 formulas, 4 products5 open orders, 1 batch in progress2 customers to notify3 procedures tagged 111.75Everything, by name
12
1

Steps with teethEach step says what it needs, who signs and how many days it gets.

2

What else does this touchOne assessment, everything the bad lot could have reached, with decisions you sign.

SOPs, training and compliance maps

Compliance maps that read your records.

Every section of 21 CFR Part 111 is a row with a status: a current SOP tagged to it, nobody with a training gap, and the records Innersol can read for it. The same for Part 117, Part 11, ISO 9001 and the GMP registration questions auditors ask beyond the rule.

  • SOP lifecycle with change control, redlines, effective dates and training on change.
  • Training plans per role, sign-offs with a signature, gaps in red on the person and on the map.
  • Internal audits planned from a map, with a CAPA from every fail and coverage over the last twelve months.
  • Management review, complaints, supplier approvals and the audit trail export, all in the same place.
app.innersol.io/quality/standards
81% compliant21 CFR Part 111 · 84 sections
6 gaps, 10 without evidence
Part 117Part 11ISO 9001
SectionRequirementStatus
111.70Specifications established for components and productsCompliant
111.75Specifications are met, identity testing on each lotCompliant
111.123Personnel qualified and trained for packaging and labelingGap: 1 training
111.160Component receipt records with supplier COACompliant
111.205Written procedures for calibrating instrumentsNo evidence
Plan an internal auditPrint the summaryCreate a gap task
12
1

Live, not a checklistA gap appears the day a training lapses or a procedure goes out of date.

2

Five maps, one scorePart 111, Part 117, Part 11, ISO 9001 and the registration audit questions.

Also in Quality

The rest of the toolkit.

Audit trail on everything

Who changed what, when, from which screen. Exported per record, per lot or for the whole period the auditor asks for.

Complaints

Logged against the lot and the customer, acknowledged with a follow-up, investigated with the same flows.

Supplier approvals

Approved, conditional, on hold. Questionnaires, documents with expiry, scores that move with real events.

Internal audits

Planned from a compliance map, each line checked live, every fail a CAPA, coverage over twelve months.

Management review

The quality numbers of the period on one page, with the decisions signed and the actions tracked.

Redlines on change

When a rule or a process changes, Innersol drafts the redline of the affected procedure and the training that follows.

Works with

Quality reads the rest of Innersol.

ManufacturingThe batch the record belongs toExplore → InventoryLots, receiving and traceabilityExplore → ProcurementSuppliers and their corrective actionsExplore → Dashboards and reportsThe quality numbers by periodExplore →
Questions

About Quality in Innersol

Are the signatures acceptable for an electronic record?

Each signature is a typed full name, a PIN and a meaning (performed, verified, reviewed, approved), hashed and linked to the record it signs, with the audit trail behind it. That is the shape Part 11 describes. Your QA team and your auditor decide what your procedures require, and the exports give them everything to check.

Can we change the deviation or CAPA flow?

Yes. Each event type has steps with the fields it needs, who signs and how many days it gets. Edit them in settings, add or remove steps, or switch a type off. Innersol's starter set is there on day one.

What does the auditor get?

The batch record as one PDF with every signature, the lot's tests and COA, the traceability both ways, the audit trail for the period, the compliance map summary, SOPs with their training records, and the deviations with their closure. All from the same screens you use every day.

Is quality a separate plan?

The quality modules are part of Enterprise. Everything else about the lot, the batch and the supplier is already in Growth and Professional, so moving up adds to records you already keep.

Walk through a batch record with your QA lead.

Forty minutes, your process steps, a signature, a deviation and a release.

Book a demoThe Enterprise plan