What Is LineDirectorTM?
Crest Solutions LineDirector™ is a centralised software control system that is designed to manage production line peripherals in an automated and compliant manufacturing environment. The system manages line peripherals such as vision cameras, sensors, printers, coding devices and checkweighers. LineDirector™ software sits below the ERP or MES system and can be incorporated into it to send data to and from peripherals. The LineDirector™ integrated suite of applications is suited to any application where machine vision, peripheral management, controlled authorisation and batch reporting are required. The system typically operates within pharmaceutical and medical device manufacturing organisations.
What Are the Key Features?
A Secure Production line: Single-point Data Entry and Automated Changeover
LineDirector™ facilitates automated batch changeover with a single point of data entry. It simplifies the process for operators while ensuring accurate data entry. Personnel can input variable data in one of three ways; by keying it in, scanning a document or by automatically downloading it from the ERP or MES system using the LineDirector™ interface. Authorised personnel have access to a recipe management interface. Data can be entered once and then translated to each peripheral in the production line as required. This is much more reliable, consistent and time efficient than allowing human interaction with the production line. The authorisation involved in the system ensures a complete ‘lock down’ of a production line to ensure no unauthorised human interference with the parameters set by the engineer. If any product is interfered with, the vision technology will detect it immediately, halt production, alert authorised personnel and log all details on the database to facilitate full Track and Trace capabilities.
Quality and Certification
Leveraging COGNEX - the world leader in Machine Vision camera systems. Crest Solutions is a Gold Standard Cognex Partner System Integrator. LineDirector™ is designed to leverage the Cognex range of vision sensors and associated equipment in an automated production environment. In addition to Cognex, another benefit of LineDirector™ is its capacity to integrate with existing equipment regardless of brand. It can manage multiple vendors, including Cognex, Markem, Videojet, Imaje, Allen, Siemens, Laetus, Omron, Micro-scan, Sick, Domino, etc.
LineDirector™ is certified with full 21 CFR part 11 capabilities for FDA regulated industries, GS1 compliance and full GAMP5 documentation.
LineDirector™ is scalable to manage one line to multiple lines and factories. It can be delivered as part of a turnkey solution which includes Crest Solution’s vision system supply and setup. It can be retrofitted to existing lines or incorporated into new line design. It is a customisable solution that facilitates full Track & Trace, Serialisation and e-pedigree implementation. An added benefit of LineDirector™ is that it can be expanded to accommodate the addition of new modules or new equipment in a production line, e.g. case packer, labeller, etc.
Quality and Control Reduce Cost Compliance: Providing the Basis to Meet Future Regulation Reduces Cost Improved Quality & Integrity Compliance Performance Ease of implementation Simplifies validation
LineDirector™provides a ‘lock down’ style of control over a production line. The life sciences sector requires a very high standard of quality and consistency from all manufacturers in the industry. Caution and stringent discipline are critical in these high risk manufacturing environments, as a defective product can have grave results for all involved. LineDirector™ guarantees quality by eliminating many of the key causes of defective products at an early stage, before damage can occur. Such causes addressed by LineDirector™ include; human interference with production lines, failure to detect a failed product or batch, failure to detect mismatching products and packaging. LineDirector™ ensures that full control of the production line lies only with the authorised personnel. Only authorised personnel can change the parameters of production on any or all peripherals. This means that random changes to the system by random staff members are eliminated and interaction with the production line is regulated and monitored. Secure login can be applied to various aspects of the system allowing different people access to different functions. LineDirectorTM also offers the ‘counter-sign’ facility which requires more than one authorised login in order to make certain adjustments. The LineDirector™ software fulfils CFR21 Part 11 criteria by logging details of any system changes including the user ID. This data is stored in the manufacturer’s server.
This is a high risk manufacturing environment. A situation with potential to result in error cannot be allowed to occur, not least due to the intangible costs associated with the production and distribution of a defective batch. Through vision and early detection, LineDirector™ saves the manufacturer these costs.
In the future, more regulations will be introduced including a requirement for the serialisation of all products. This means that Track and Trace capabilities for all products manufactured in pharmaceutical and medical manufacturing plants will become a basic requirement. LineDirectorTM provides the basis for this procedure and includes the added benefits of vision technology operating at multiple points in the production line providing early detection of defects and logging details on the manufacturer’s server. This complies with FDA standards and saves time and cost incurred through errors occurring during the manufacturing process.
Quality and Control
Compliance: Providing the Basis to Meet Future Regulation
Improved Quality & Integrity
Ease of implementation