Linda Proctor has over 25 years experience working with the premier pharmaceutical, biotechnology and medical device companies.  Areas of expertise include quality systems, training, internal audits, Part 11 GAP Analysis, SOP development and cleaning and computer system validation. 

PCS has participated in numerous FDA inspections and can assist your company in preparing for the FDA, EU and other regulatory inspections.  PCS will assess your company's preparedness for the regulatory requirements.   Recommendations for correcting non-compliance issues will be made.  PCS will work with the client to resolve all non-compliant issues by suggesting corrective actions and/or locating required resources to complete the corrective actions.

PCS follows the SYSTEM LIFE CYCLE methodology in validation of computer systems.  PCS will prepare a full suite of validation documents as required.  PCS will work with the client to customize the work to supplement in-house resources or provide all resources to complete the project.

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