MANUFACTURING SYSTEMS IMPLEMENTATION & VALIDATION

In addition to all of our Hands On scientific services, Sigma Biomedical exercises all-inclusive validation consulting to one of the most scrutinized and thoroughly regulated business areas
Regardless of the clients’ project scopes, we will help ensure product quality by:

• Preparing meticulous Validation and Verification Plans for New   Manufacturing facilities

• Developing and Implementing software packages necessary to   satisfy all applicable Quality System Regulations (21 CFR Part 820)   and any other requirements related to the Manufacturing Floor

• Executing Validation of Automated Assembly and Packaging Lines

• Developing challenging Installation Qualification, Operational   Qualification as well as Performance Qualification testing protocols   for each applicable Automated Control Mechanism

• Creating real-time software applications used in Industrial Process   Monitoring & linked Disaster Recovery Management

• Developing competent Software Interfaces that examine   Programmable Logic Controller (PLC), Supervisory Control & Data   Acquisition (SCADA) and Numerical Control (NC) subsystems

• Validating business-related third-party Integrated Management   Software Packages

ANALYTICAL METHODS VALIDATION

Analytical Methods utilized in regulated laboratories must be validated in order to establish evidence that they are reliable, robust and can generate repeatable results. Failure to produce concrete Analytical Method Validation documentation, necessary to demonstrate compliance to global regulatory agencies, may result in embarrassing Product Recalls, Severe Fines and/or Legal Accountability.  Sigma Biomedical validates our clients’ Analytical Methods by providing services such as:

• Validation Master Planning

• Qualitative and Quantitative Gap Analyses

• Creation of Validation Protocols

• Preparation and Implementation of SOPs