We capture incoming, in-process and final inspection records on a tablet on the shop floor; when a non-conformance appears we quarantine the goods, start the corrective and preventive action (DÖF / CAPA) flow and follow it through to closure. Measurements, certificates and approvals accumulate by batch, so you go into an ISO 9001 audit with a file that is already prepared rather than one assembled retrospectively from binders.
In most factories quality records really are kept; the problem is what happens after they are kept. The inspection form is filled in by hand during the shift, goes into a binder at the end of the day and waits there. Because the measurements are on paper they are never brought together anywhere, and nobody knows how many times the same defect has recurred over the past three months. When a customer complains, the binders are searched one by one to find which batch the product came from; and even when it is found, which raw material, which machine and whose shift produced that batch turns into a separate hunt. As the audit date approaches, the team spends weeks assembling paperwork after the fact. That effort is genuine effort, but it does not improve quality itself; it only makes the record visible.
The second problem is that the certificate comes apart from the system. In a company with an ISO 9001 certificate the documents are defined, the procedures are written and the audit is passed; yet the daily reality of production usually flows outside those procedures. A corrective and preventive action record — DÖF in Turkish, CAPA internationally — is opened and an owner is assigned, then it never closes because nobody follows it up, and the same finding is written again at the next audit. It looks as though root cause analysis has been done, but the same non-conformance recurs on the same machine. This is where the real work of quality management system (QMS) software begins: not collecting the record, but making the decision that follows the record, and the closure of that decision, compulsory.
In the structure we build, the control plan is defined per product and per operation: which characteristic is measured at which point, how often, with which instrument and within which tolerance range. Measurements are entered on the shop floor from a tablet or terminal, and a value outside tolerance raises an alert immediately. Non-conforming goods are quarantined and blocked in the system; a blocked batch can no longer be selected on the dispatch screen, so the decision does not stay on paper — it actually stops the flow. The non-conformance is linked to a DÖF/CAPA record with an owner and a due date, and closure requires evidence. The certificate of analysis (CoA) is produced from the same measurement data, so the document that goes to the customer and the record kept internally come from the same source.
This page is written for general manufacturing: quality processes running along ISO 9001 lines in fields such as food, textiles, plastics, packaging, machinery and metal. Medical device manufacturing is a separate, regulated field; ISO 13485, an electronic quality management system (eQMS), UDI coding and ÜTS (the Turkish medical device tracking system) notification are handled under their own rules, and we cover that separately on our medical page. In the interest of honesty, one more point up front: software does not raise quality, it makes quality measurable and traceable. If the measurement method is wrong, the system will accumulate wrong data faster. We also do not promise certification; the certificate is issued by a certification body, and all we do is make sure the records requested in an audit are ready and traceable.
Companies with written procedures that pass their audits but keep the daily quality record on forms and in Excel. The distance between the certificate and the shop floor opens up furthest in these businesses. The records are already being kept; what is missing is having them together, searchable and time-stamped. The first gain is the end of the weeks-long scramble to assemble paperwork before an audit.
Companies producing for a main manufacturer, a retail chain or an overseas buyer, hosting more than one customer audit a year. What these audits ask for is usually not the existence of the procedure but dated evidence that the procedure was followed. Holding measurement, approval and corrective action records in a system meets that demand directly.
Businesses producing food, chemicals, packaging and food-contact products. When a complaint arrives, it is mandatory to trace back which batch was produced with which raw material and on which shift. Once the quality record is linked to the production record through the same batch number, that trace stops being a binder search and becomes a query that takes minutes.
Businesses where the inspection criteria, acceptance limits and customer-specific exceptions are known only to the quality manager. If that knowledge is not written down, decisions either stop or are made wrongly when that person leaves or goes on holiday. Entering the control plan into the system is the most concrete way of moving this knowledge from the individual to the organisation.
A control plan is defined per product and operation: which characteristic, at which point, how often, with which instrument and within which tolerance range. Incoming inspection, in-process control and final inspection all run in the same structure. Measurements are entered on the shop floor from a tablet or terminal; a value outside tolerance raises an alert the moment it is recorded, and a mandatory field left blank will not close the record.
Samples taken are recorded by barcode, with which batch they came from, who took them and when. The instrument used for the measurement is held within the record and the validity of its calibration is tracked. A reminder goes to the owner as the calibration date approaches, and a measurement taken with an out-of-calibration instrument raises an alert. This is one of the points most often asked about in an audit.
When a non-conforming product record is opened, the batch concerned is quarantined and blocked in the system; a blocked batch cannot be selected on the dispatch or production issue screens. Release, conditional acceptance, rework and scrap decisions require authorisation and are recorded with their justification. The decision does not stay on paper; it actually stops the flow, or releases it.
A non-conformance is linked to a corrective and preventive action record (DÖF, known internationally as CAPA). Owner, due date and root cause analysis are mandatory fields, and evidence is required for closure. Overdue records escalate to the manager. Recurring non-conformances are grouped under the same product, machine or supplier, so it becomes visible which problem has genuinely not been solved.
The certificate of analysis and the declaration of conformity that go to the customer are produced from the measurement records held internally; the document is not written by hand. Templates can be separated per customer and per product and prepared in several languages. Which document belongs to which batch and who approved it are on record; when a second copy is requested for the same batch it is not prepared again but issued from the archive.
Every record is stored with the information of who created or changed it, when and with which value; instead of deletion, cancellation with a justification is used. Document versions, approvals and read receipts are tracked. When an audit comes, the records for the requested period and product are filtered and exported from a single screen; there is no need to search through binders.
Reject rate, rework, scrap and customer complaints are reported by product, machine, shift and supplier, and recurring defects are ranked. If you wish, these records are combined with production data to calculate the cost of a defect. Reports arrive ready for the management dashboard and for the periodic review meeting, so the quality discussion moves beyond the level of general good intentions.
Together with the quality team and the shop floor we map the current flow: which inspection is done where, which form is filled in, who makes the decision, how non-conforming goods are actually stopped. Findings raised in previous audits are an input as well. The output is an inspection and decision map we have agreed on.
Inspection points, tolerance ranges, measurement frequencies and instruments are entered into the system per product and operation. Who is allowed to make which decision in the event of a non-conformance is set out in an authorisation matrix. This is usually the longest step, because rules that have never been written down are put in writing for the first time.
Record screens, the quarantine and blocking flow, the DÖF/CAPA structure and the document templates are developed. They are trialled on the shop floor with a single product group or a single inspection point. How many seconds it takes an operator to enter a measurement is a criterion for us; every field that slows entry down is debated again. Every delivery goes through four-eyes review.
For an agreed period the paper form and the system run side by side; records are compared and any remaining gaps are closed. Team training is delivered at this stage. Once the results settle, the paper is withdrawn and the scope is widened to the other product groups. Making the transition gradual prevents gaps in the records during an audit period.
After go-live we run an audit rehearsal: we pull the requested records out of the system and look for any field left incomplete. We provide monitoring and fault resolution support under an SLA. As standards are revised, customers make requests or new product groups arrive, we update the control plans together with you.
Partly. The structure here is built for general manufacturing and the ISO 9001 axis. Medical device manufacturing is a regulated field; ISO 13485, an electronic quality management system (eQMS), UDI coding, ÜTS (the Turkish medical device tracking system) notification and technical file requirements must be handled under their own rules. We cover that subject separately on our medical device software page, and we discuss work in that field within that framework. Combining the two areas on one page would mean explaining both of them incompletely.
No, and we do not promise that. The certificate is issued by a certification body; the software ensures that the records requested in an audit exist, are up to date and can be presented quickly. In practice, where it helps most is with findings that arise from missing records or from records assembled after the fact. The procedures themselves, the measurement method and your team's practice remain your responsibility; the software does not take their place.
This is the issue that actually determines whether the project succeeds, and we design around it. The measurement screen is built so that it can be completed with one hand, wearing gloves, in a short time; the number of mandatory fields is limited to what is genuinely needed. Scanning a barcode to select the product and batch replaces typing. We do not roll anything out without trialling it on the shop floor; rather than leaving a screen that takes too long to fill in and waiting for the team to get used to it, we redesign it.
It does not clash; it connects. Product, batch and work order information comes from your existing systems, and the quality record is written on top of that batch number. The blocking decision is passed to the stock and dispatch side so that it takes effect in practice. If you have a production tracking system, we do not rewrite it; during discovery we make clear which data flows in which direction and decide together whether the integration runs one way or both ways.
You can remove most of them, but not all. Some records may be required with a wet signature by a customer or by regulation; in that case the document is produced from the system, signed, and the scanned copy is attached to the record. Our aim is not to ban paper but to prevent paper existing as a single copy in a single binder. We identify which forms will stay one by one during discovery and plan the transition accordingly.
Control plans defined per product and operation; measurement records entered from the shop floor; a quarantine and blocking flow; DÖF/CAPA records with an owner, a due date and evidence; certificates of analysis produced from measurement data; an audit trail carrying who did what and when, and periodic quality reports. Everything, including the source code, the documentation and the quality data you accumulate, belongs to you.
In a 30-minute discovery call we listen to what you need and tell you honestly whether custom development or an off-the-shelf product is the better answer.
Working from your bill of materials (BOM), we calculate which material is needed, in what quantity and by when; then we deduct stock on hand, open orders and lead times to produce dated order proposals for purchasing. With the MRP II layer we also test the same plan against machine capacity and labour.
Details →We build the software a dealership, a showroom and an authorised service centre run their own business on: vehicle or product stock, the showroom sales process, service appointments and work orders, warranty claims and integration with manufacturer-side systems come together in one structure. Your existing accounting package stays where it is, and the source code is yours.
Details →For companies whose sales run through dealers, distributors and solution partners we build channel software: partner records and tiering, target and commission calculation, lead sharing and conflict prevention, marketing collateral, and training and certification tracking are brought together in one place.
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Details →We unify the customer data held on your website, e-commerce platform, CRM, call records and in-store tills under a single identity. Duplicate records are matched, segments are generated by rule, consent status travels with every record, and segments are pushed to channels in a controlled way. The aim is not another report, but a working customer view that the channels can use every day.
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