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Need Help with FDA Regulatory Challenges? We're Here to Help.

Established in 2001, Process XL Consulting Group is a best practice provider of Auditing & Regulatory Compliance, Computer System Validation, and Information Technology Management consulting services to the pharmaceutical, biotechnology and medical device industries.

We specialize in solving regulatory challenges requiring process and technology solutions by helping you define your requirements and processes; then leading the development of a solution by evaluating, selecting, and implementing a packaged market solution, and/or developing and implementing a custom software solution that is compliant with FDA regulations for GxP Computer Systems Validation.

We have a proven track record of successfully delivering mission critical regulatory compliant solutions for leading Global Life Science clients on time, on budget, and to customer satisfaction.

Process XL provides full service GXP (GCP, GLP, GMP) Computer System Validation and IT Project Management Consulting Services to the BioPharma industry.

Services Offerings include:

- Computer Systems Validation Assessment & Remediation

- 21 CRF Part 11 Assessments

- Gap Analysis

- Procedural Compliance Assessments

(SOPs, Policies, etc.)

- Vendor Assessments & Audits

- Prescription Drug Marketing Act Assessment & Remediation

- Validation of computer systems, e-records, e-signatures and methods used

- Quality Systems Development

- Systems and Compliance Strategy Development

- System analysis, requirements, specifications, evaluation, selection, integration, and retirement.

Regulatory Expertise Includes:

- Good Manufacturing Practice GMP

- Good Laboratory Practice GLP

- Good Clinical Practice GCP

- Electronic Records/Electronic Signatures -21 CFR Part 11

- Prescription Drug Marketing Act PDMA

- Privacy Regulations (EU Safe Harbor, HIPAA privacy provisions)

- Good Automated Manufacturing Practice ISPE GAMP 5

Process XL Consulting Group LLC
Rick Pultorak

Phone: 610-871-5381
152 Sunny Brook Road, Suite 100
Royersford, PA 19468
rpultorak@processxl.com

Process XL Consulting Group

GxP Regulatory Compliance Consulting and Solutions.