21 CFR Part 11 Compliance
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
IEC 61131 Compliance
Part 3 of IEC 61131 deals with programming languages and defines two graphical and two textual PLC programming language standards:
• Ladder diagram (LD),
• Graphical Function block diagram (FBD),
• Graphical Structured text (ST),
• Textual Instruction list (IL), textual
• Sequential function chart (SFC), has elements to organize programs for sequential and parallel control processing.
S88 and S99 Compliance
S88 defines hierarchical recipe management and process segmentation frameworks, which separate products from the processes that make them. The standard enables re-use and flexibility of equipment and software and provides a structure for coordinating and integrating recipe-related information across the traditional ERP, MES and control domains.
Electronic Batch Record Systems (EBRS)
Electronic Batch Record Systems helps pharmaceutical companies meet the critical challenges of increasing productivity while maintaining compliance levels required by the FDA
Project and Consulting Services
• Design Review for GMP Compliance
• Design Specification Development and Review
• Pre-qualification (FAT/Commissioning/SAT) Documentation Development, Review and Execution
• Quality Plan Development and review
• Validation Master Plan Development and Review
• SOP Development and Review
• Protocol Development, Review and Execution
• Risk Analysis (DFMEA, PFMEA) Development and Review
• Re-qualification Program Development
• Process Validation (IQ/OQ/PQ)
• Source Code Review
• Consultancy
• Support
24x7 Support Contracts
lotus Automation has dedicated teams of support engineers in each of its regional offices, available to help customers diagnose and correct faults either on the telephone or through site visits. This help is available 24x7 if needed
Batch Management Systems
Control of batch processes demands more of the automation system than straight forward control and supervision. An important issue in batch processes is the data handling. The control task of the process objects is important, but batch control also requires handling of information.
High Availability Systems
High-availability systems are specially designed to reduce the risk of production downtimes. In the event of a fault in the master system, the system switches to the stand-by station. It is suited for high-availability process with hot-standby requirements (processes with switchover times of less than 100 msec).
18001 provides a framework for managing Health and Safety Management responsibilities through an Occupational Health and Safety Management System, it enables our company to control our health and safety risks and improve our performance. Lotus is certified to OHSAS since 2006.
Lotus is ISO 14001 certified since 2006 and this internationally accepted standard assisted us in putting an effective Environmental Management System in place. The standard addresses the delicate balance between maintaining our profitability and reducing our environmental impact.
ISO 9001 is the International standard for Quality Management Systems (QMS). It provides our company with a set of principles that ensures a common sense approach to the management of our business activities to consistently achieve customer satisfaction. Lotus is certified since 1999.
