Technical Enablers
SOP Development
We help our clients develop Standard Operating Procedures (SOPs) that outline the procedures for various processes in the production of pharmaceutical products.
Documentation Management
We help our clients manage their documentation, including the development of document control procedures and the implementation of a document management system.
Validation Master Plan (VMP)
We help our clients develop a Validation Master Plan (VMP), which outlines the validation activities required for the various systems and processes used in the production of pharmaceutical products.
Site Master Plan(SMF) & Quality Manual
We help our clients to prepare Site Master File with comprehensive information about the manufacturing and control of the pharmaceuticals product and provide guidance on how to implement and maintain Quality Management System and its Compliance with regulatory standards at their site.
Risk Management
We help our clients perform risk assessments by FMEA, FMECA, HACCP, HAZOP/PHA/RISK RANKING AND FILTERING to identify potential problems and hazards in the production of pharmaceutical products and develop mitigation strategies to minimize risk. Through RISK ASSESSMENT, PROCESS RISK MANAGEMENT, QUALITY RISK MANAGEMENT
Quality Management System
Quality Management Software-Quality management software is used to automate various quality management processes, including risk management, change control, and complaint management.
Quality System Maintenance – We help our clients maintain their quality management systems, including the regular review and update of policies, procedures, and processes.
Document Management Systems – We help our clients to develop A document management system (DMS) to store, manage, and track the production and revision of quality management system documents.
Statistical Process Control (SPC) – We help our clients to develop a statistical technique used to monitor and control a process to ensure it is in a state of statistical control and producing a product of consistent quality.
Capa (Corrective and Preventive Action) System – We help our clients to develop A capa system is used to track, investigate, and resolve problems that arise during the production of pharmaceutical products.
Training Management System – We help our clients to develop A training management system is used to manage the training of employees and ensure they are properly trained on the policies, procedures, and processes of the quality management system.
Qualification and Validation
Our team of experts provides comprehensive validation and qualification services, including
- Validation master planning
- Validation protocol and report writing
- Execution of validation studies
- Equipment and system qualification
- Equipment Qualification (EQ)/Utility Qualification
- Computer System Validation (CSV)
- Process Validation
- Cleaning Validation
- Method Validation
- Water Qualification
For any Query call us
If you have any question or would like to learn more about our services, please don’t hesitate to contact us using the information provided on our website.