Quality Control/Assurnace

Most organisations today have to comply with internal and external requirements and expectations related to how they manage and control quality, both in terms of operations, products, services, clients, general stakeholders and public relations. The organisations’ ability to measure and manage performance and utilise this information to evolve and improve is a critical success factor.

To control quality, one must effectively control quality documentation, such as SOPs, policies, quality manuals, CAD files, and specification sheets. Document control systems streamline these vital quality processes. It will help to ensure compliance with FDA regulations, ISO quality standards, and other regulatory requirements. Continuous compliance ensures that an organization’s quality system always ready for inspections and audits.

Each manufacturing company has its own unique production flow. But every companys production is reliant on a specification and bill of materials (BOM) systems that can accurately identify and list the components required to produce a particular product at any given revision level. Bill of materials software can help companies simplify and standardize BOM management across departments to ensure dynamic and profitable manufacturing

Inspection requests and work orders automatically generated from pre-established inspection schedules. Define inspection schedules for Receiving, Production/Lots and on-hand inventory. Initiate inspection for customer returns and create inspection procedures

Providing a proof of proper handling of every step in the production of each batch/lot is essential for quality management system to fulfil the requirements of regularity authorities. Software tracks all routing information and data entered into the electronic form, allowing the batch/lot coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing. Production records can be trended and analyzed by product, recipe, process stage, etc.

A comprehensive process starts with the processing of a customer complaint by the coordinator/manager, automatically moving to the internal investigation step (conducted either by an expert or a team of experts), and culminating with the resolution of the issue as approved by the appropriate manager. System gives you the option to integrate customer complaint handling with the NC and CAPA. Customer complaints/feedback system has advanced reporting capabilities like; Complaint summary, In-process complaints, Complaints categorized by type, product, and department.

Corrective Action (CAPA) software system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance. CAPA system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. CAPA form can be launched directly from another form (i.e., customer complaint, feedback etc.) to streamline the CAPA process and avoid mistakes during re-entry of data.

Accurate functioning of machinery, instruments, apparatus, gauges, and recording devices is critical in the manufacturing and analysis of product. The calibration and maintenance schedule manages and automatically triggers all calibration tasks before the due date is reached. Specific instructions, including spare parts lists and required equipment lists, are created during schedule setup. Calibration certificates and maintenance invoices can be stored as PDF with each record.

Supplier evaluation and re-evaluation reports are maintained that include lists of the goods or services a supplier is approved to supply, contact information for each supplier returned, and those suppliers ratings. All supplier management statuses and quality information (such as nonconforming material reports) is automatically contained in a single, easy to access location. The Supplier view in the supplier management system displays a Supplier Status field for each supplier, indicating if that vendor is approved or not.

Training control software automates training management from start to finish by automatically delivering training tasks, grading online exams and integrating with quality processes. Trainees have access to their training records in the training software with a personalized folder that shows past training, course due dates, and future training. The training coordinator can run a report according to required training by trainee, completed training by job code, or pending training by course, and find out how many people have completed their tasks.

System helps automate the administrative processes that bottleneck the flow and timely completion of essential HR tasks. HR/Finance solution automates the following processes; new employee checklist management, employee exit checklist management and purchase order fulfilment. You can predefine roles, job descriptions and HR processes for employees.