cGxP Services Offered


Data Integrity

Assessments, Remediation Plans, Procedures, and Training for Laboratories, Manufacturing – (21 CFR Part 11, Annex 11), Clinical Device ( 21 CFR 807, 812, 814, and 820), Regulatory (Submission Data), and Quality Systems (Electronic and Manual processes) based on current Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA) guidelines and applicable regulations.

Validation

Project Management and hands-on Computer System Validation (CSV) upgrades and new implementations. Technical document development including requirements, change management, specifications,  customized plans, test plans (IQ, OQ, and PQ), and reports based on GAMP 5 and Agile methodologies.

Cloud-based Systems

Software as a Service (SaaS), Platform as a Service (PaaS), and Infrastructure as a Service (IaaS) consulting, supplier selection, audits, and implementation management. Solution selection comparisons and evaluations. Customized risk-based validation documents and execution.

Laboratory

Chromatography Data System (CDS), Laboratory Information Management Systems (LIMS), Electronic Notebooks, and Standalone implementations, upgrades, and interfacing. Legacy System remediation and controls. Procedure and Work Instruction development and training.

Supply Chain Management

Supplier Audits and evaluations. Approved Supplier List (ASL) consulting and management. Supplier Qualification methodologies and implementations. Supply Chain Mapping and detailed diagrams.

Quality Management

QMS modules business rules, configuration, and workflow analysis. Corrective Action Preventive Action (CAPA) strategies and management based on quality tools and techniques. Requirements Gathering with Critical Quality Attribute (CQA) and Critical Process Parameter (CPP) identification and mapping.

Risk Management

Failure Modes and Effects Analysis (FMEA): Functional, Design, and Process models. Customized development – team led sessions. Customized Risk Models and mitigation controls. Warning Letter response and remediation planning.

 

Enterprise Systems

Enterprise Resource Planning (ERP) systems quality consulting and validation. Business Analyst process workflow mapping for Quality Management modules. Identification and risk-based evaluation of critical quality process steps.

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