VALIDATION

Sparko Quality Consulting (SQC) offers validation supports to a miriad of different clients with different needs.

Some clients will have evovled validation systems while others will not. SQC is happy to provide support where it is required.

We have the expertise and due diligience in our work to achieve any goals that our clients require.

Validation services provided by SQC validation consultants provide the client with the utmost confidence that sampling is completely representative of their batch quality.

Sparko Quality Consultancy utilises a cost effective, risk-based approach to validation which is always up to date and constantly evolving with any regulations that may arise.

SQC has experience in Pharma validation as well as medical device validation of direct and indirect manufacturing systems through a risk-based and vetted approach.

We have experience in a whole host of validation scenarios through a number of years in the field. Whether you require an experience GXP engineer, a validation specialist or a medical device engineer, SQC can provide the expertise required.

Our validation life cycle services for all systems and equipment include, but are not limited to:
– Risk-Based Approaches
– Concurrent, Prospective and Retrospective Validation
– Full Documentation Packages and Reports
– Test Protocol Writing and Execution
– Commissioning and Qualification
– Reports and Requirement Traceability Matrix
– Equipment Validation
– Cold Chain Validation
– Medical Device Validation
– Gap Analysis and Remediation
– Cleaning Validation
– Spreadsheet Validation
– Drawing Updates and all CAD requirements
– Thermal Mapping using Kaye Validators
– Automation and Computer System Validation to GAMP 5 ®
– Electronic Signatures and Records / Data Integrity
– Maintenance Databases
– Software Validation