© 2017 Validation Systems

Gap Analysis and Quality Audits
Quality Manual and Quality System Procedures Writing

VSI can work with your Quality department to develop a customized Quality System that meets your specific need while also addressing all regulatory compliance requirements. We realize that a Quality System must be thorough and Our focus is on creating Quality Systems that are thorough, but also easy to follow.

Our Quality System Development services include:

  • Quality Manual and Quality System Procedures Writing

  • Gap Analysis and Quality Audits

Quality Systems Services

A well developed Quality Manual customized to your company’s needs is a valuable tool in achieving regulatory compliance. VSI can write a Quality Manual for your company that will establish corporate quality policies and responsibilities, outline the requirements for compliance, and provide an overview of your Quality System.

VSI can develop customized SOPs to support your Quality System and ensure regulatory compliance. We can work with your Quality Department to develop procedures that are easy to follow and meet your specific needs.

These procedures include the following:

  • Change Control/Document Control, Processing, Archival

  • SOP Format/Numbering

  • Master Batch Records

  • Test Methods

  • Equipment SOPs

  • Personnel Training

  • Documentation Practices

  • QA Audit Program

  • Receiving

  • Receiving Inspection

  • Material Status Labeling

  • Validation Policy

  • Lot Numbering

  • Manufacturing Line Clearance/Start-up

  • Equipment Calibration/Maintenance/Logbooks

  • Variance/Deviation

  • OOS

  • CAPA

  • Failure Investigation

  • Non-conforming Material Control

  • QC Sampling

  • Product Release

  • Record Retention

  • Product Retentions

  • Facility Inspections by Regulatory Agencies

  • Corrective Action

  • Change Control for Validated Systems

VSI can perform a Gap Analysis of your existing Quality Systems, Validation Programs, and Quality Control Laboratory Programs. A Gap Analysis is essential in determining whether the programs in place are sufficient and that you are compliant with with your policies. We can provide you with a comprehensive report including observations about your current systems and recommendations for improvement.

We can also provide auditing services for both internal audits and external audits of vendors, suppliers, and outside test laboratories. We write detailed audit reports to allow you the necessary information to make an informed assessment.