GMP Data Integrity and ALCOA+: A Six-Step Guide for Production and Laboratory Records
What do GMP data integrity and ALCOA+ require? Apply them with a six-step plan, based on FDA and MHRA guidance, for audit trails, accounts and hybrid records.
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Quality management software brings control plans, measurement records, SPC control charts, nonconformances, 8D investigations and calibration tracking into one system. Each measurement is checked against tolerance and control limits as it is taken, and the right person is alerted when a process drifts, so bad batches are caught on the line rather than at the customer.
In many plants, measurements still go onto paper check sheets that end up in a binder. The data is there when the auditor asks, but nobody looks at it while the line is running. By the time a drifting process is noticed, the batch is finished and the problem surfaces at the customer's goods-in inspection. Then the 8D starts, and days go into chasing forms, emails and spreadsheets.
We build quality management software that evaluates every measurement the moment it is taken. Your control plan lives in the system; operators enter readings on a tablet, or a connected digital gauge sends them directly. When a value falls outside tolerance or a control chart starts to drift, the right person is alerted straight away. Nonconformances, quarantine, 8D and calibration records sit in the same system and link to each other, so audit preparation stops being a separate project. For procedures, work instructions, quality documents and supplier contracts, our business file management product SmartFiles keeps documents in department areas, with version history for every file and access granted per person or department.
Define which characteristic is checked on which part, how often and with which gauge. Operators see the next check and its tolerance on screen, and a skipped check is logged.
X-bar/R charts and Cp/Cpk update automatically with every reading. You are warned as the process approaches its limits, so you can act before a bad part is made.
Nonconforming product is quarantined in the system and blocked from dispatch. Scrap, rework or concession decisions are recorded with who made them and when.
Open an 8D for a customer complaint or an internal defect. Fishbone and 5 Whys analyses run in the system, and every action has an owner and a due date.
Trace forward and backward which raw material, machine and operator went into each batch. When an issue arises, the affected batches are listed within minutes.
Calibration due dates for callipers, micrometers and test equipment are tracked. Readings cannot be entered from a gauge that is out of calibration.
On a machining line, the diameter of a shaft starts creeping towards the upper tolerance as the tool wears. When the operator takes the reading with a digital calliper, the value is still in tolerance, but the control chart shows the trend and the quality lead is alerted; the tool is changed before a bad part is made. If any parts have already gone out of tolerance, the batch is quarantined in the system and blocked from dispatch. The traceability record shows which machine, operator and raw material went into the batch, so when the customer asks, the answer is in one record rather than a stack of forms.
We go through your control plans, check sheets and nonconformance flow, and list what your standard and your customers require.
We set up the part, characteristic and tolerance structure, and agree inspection points, frequencies and owners.
We connect digital callipers and test equipment and design operator screens for real shop-floor conditions.
We start on one line, settle control limits with real data, then extend the system to the rest of the plant.
For visual checks such as scratches, missing components or label errors, we connect our AI-based computer vision systems to the quality software. When the camera spots a defect, a nonconformance record is opened without operator intervention. For deeper batch and material tracking, see our production traceability solution; to see quality data alongside downtime and scrap, see our MES production tracking software. If process drift comes from the machine itself, predictive maintenance shows the fault while it is still developing. To keep procedures and work instructions in one place with full version history, you can buy SmartFiles now.
Related guides: QMS software modules and selection criteria, SPC, Cp and Cpk with a worked example, the 8D problem-solving steps. For more, browse our Industry 4.0 guides.
Let us go through your control plan and nonconformance flow together, then set out the scope and cost of a first pilot line in a written proposal.
Quality management software brings control plans, measurement records, SPC control charts, nonconformances, 8D investigations and calibration tracking into one system. Each measurement is checked against tolerance and control limits as it is taken, and the right person is alerted when a process drifts. Bad batches are caught on the line rather than at the customer's goods-in inspection, and audit records build up as you work.
Yes. X-bar/R control charts and Cp and Cpk values update automatically with every new measurement. Operators enter readings on a tablet, or a connected digital gauge sends them directly. When a process starts drifting towards its control limits the system raises a warning, so action can be taken before defective parts are made. Control limits are set from real data on a pilot line.
A nonconforming product is placed in quarantine in the system and its shipment is blocked. The scrap, rework or concession decision is recorded with the name of the person who made it and the date. If visual checks are connected to our AI-based computer vision, a nonconformance record is opened automatically, without operator intervention, when the camera detects a defect.
Yes. An 8D can be opened for a customer complaint or an internal defect, with fishbone and 5 Whys analysis carried out in the same record. Every action has an owner and a due date that are tracked. Because nonconformance, quarantine and traceability records are linked to the 8D, no one spends days collecting forms, emails and spreadsheets.
Calibration dates for callipers, micrometers and test equipment are tracked in the system. Measurements cannot be entered with an instrument that is overdue for calibration, so readings from an invalid instrument never reach your quality records. These records sit in the same system as measurements, nonconformances and 8Ds, so audit preparation stops being a separate project.
We first review your control plans, forms and nonconformance flow, and list the requirements of your standard and your customers. We then set up the product, characteristic and tolerance structure, connect digital gauges and design operator screens. The system runs on one line first, control limits are set from real data, and it is then rolled out to the other lines.
As we do not sell off-the-shelf packages, the cost depends on the number of lines and inspection points, the gauges to be connected and the modules you need. We review your control plans and check sheets during the initial assessment, then set out the scope, phases and cost in a written proposal. Because the system goes live on a single pilot line first, the first step is limited to that line.
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