Hazel McMeekin
SciVal Ltd

Hazel is an independent consultant highly experienced in regulated systems implementation:

Regulated Computer Systems Implementation

• Full project management of a regulated application deployment
• Production of Project Management/CSV plan
• Structuring & gathering user requirements (URS)
• Preparation/execution of installation qualification (IQ)
• Preparation/execution of operational/performance qualification (OQ/PQ)
• Preparation of Validation Summary Report

Consultancy on the CSV Process

• Development of CSV Procedures
• Policy statement development
• Template document development

CSV Process and Quality Training

• Training on regulatory requirements – current thinking
• Meeting the requirements
• Delivering a qualified system
• Maintaining the validated state
• Risk analysis applied to CSV
• Data Integrity and CFR 21 part 11

Quality Review

• Support CSV audit
• Supplier/vendor audit
• Validation document review/approval

CSV Readiness Evaluation

• GAP analysis on procedures
• GAMP5 planning
• Planning for a new development

Planning for a major upgrade - think about validation and regulated implementation!

Availability for Work

United Kingdom, Europe, Worldwide

Areas of Expertise

Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Information Technology (IT/CSV), GAMP5, Instrumentation & LIMS

Contact Details

Hazel McMeekin
Garden Cottage
By Denny
Stirlingshire
Scotland
FK6 6QZ

Telephone: +44 (0) 7944 053278

E-mail: hazel@scival.co.uk

Back to Register of Consultants