Compliancy and Validation

PharmaCIMS Professional Services

Regulated industry sectors, such as pharmaceutical, chemical and food/beverage, are becoming more and more regulated as time goes by. There are increasing pressures from competitors, markets and shareholders to improve performance and results. Information systems, Laboratory Automation, and ERP help companies comply with governmental regulation and ensure the safety/quality of their products.

PharmaCIMS Life Sciences and Technology professionals are equipped with mass amount of professional experience in implementing, qualifying, and validating the GxP based Information Management Systems solutions for the regulated industries. Our area of expertise expands to Risk Management, Laboratory Sciences, Life Sciences, Biology Sciences, Drug Safety, and Pharmaceuticals QA Business Process Improvement. This capability delivers advanced solutions to enable Pharmaceuticals, Chemical, Food/Beverage, and Biotechnology customers to solve their business problems effectively. Through this process our consultants utilize a formal Project Management methodology to effectively advise clients of our progress with maximum output and minimum risk.

More Areas of Expertise - Formal Project Management - Formal Training - WAN implementation and validation with external CROs. - LAN and Internet setup/validation to connect to FDA's ESTRI Gateway. - Biostatistics SAS Implementation - Supervisory Control and Data Acquisition (SCADA) - LIMS Installation - Environmental, Gas, Water, Gowning - LIMS process Analysis and Reporting - Stability Analysis, Implementation, and Validation - Instrumentation Network Installation, Integration, and validation - 21 CFR Part 11 (eSig) Consulting, and Training for GLP and GCP.

Validation & Document Management - IQ/OQ/PQ protocols, Reporting, and Archiving. - Validation Script Writing. - Vendor Audit & Reporting - SOP Development & Control

IT Qualification Practice | Benefits | 21 CFR Part 11