Quality Management System

SigmaTech 3.1   

SigmaTech 3.1  is a software for achieving objectives of QbD. It is useful for Designing and building quality into the process using DOE technique.

The statistically planned experimental data will be analysed by this software to build the statistical/mathematical model and provide various simulation techniques for optimal design of the process.  This software is useful for applications in Research & Development of API(active pharmaceutical ingredients), Pharmaceutical formulations, Biotechnology Process, Contract Research work, Chemical Process and Analytical Research work.

Quality Management System

• Some of the salient features of this software are:
• Helps in screening for the vital few variables
• Helps in Robust Process design with cost optimized
• Helps in process validation
• Enables Six Sigma Process development
• Regulatory compliance with 21 CFR part 11
• Screens cost effective alternative materials
• Identifies the key factors affecting a process consistency
• Balances multiple output characteristics to achieve desirable out comes
• Significantly reduces the rejections to improve the bottom line of an organization

• Redesigning of SOP and other documents of Plant
• Qualification and Validation: Qualification and Validation are integral steps in building quality into any facility. HLS provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

• Validation Protocol Preparation & Execution:

1.  Validation Master Plan
2. Deign Protocols
3. IQ protocols for all types of Equipment
4. OQ Protocols
5. PQ protocols
6. Conducting Process Validation at your site
7. Area Validation (HVAC)

• Purified Water Validation Protocol & Validation
• Manual Preparation
• Site Master File
• Validation Master Plan
• Quality Manual
• Safety Manual
• Training Manual
• Standard Operating Procedures (All department present in unit)
• Quality Assurance Procedures
• Quality Control Procedures
• Warehouse/Store
• Engineering/ Maintenance
• Production
• Human Resource
• Redesigning of Manufacturing batch records and Batch packing Record.
• Redesigning of Specification and Method of analysis.
• Redesigning of Master Formula Record