About Sterling Development LLC

Sterling Development LLC provides computerized system implementation and validation services, including project management, primarily to medical products companies.

Service areas includes all aspects of software quality assurance, for example:

• Computerized System Validation
• Data Integrity Assessment
• Validated State Review
• Master Plan for Computerized Systems
• Change Control
• Supplier Qualification
• Risk Assessment

Sterling Development LLC incorporated in California in November 2015, with a business office in Moorpark, California.

Sterling Development LLC can work at the client site, remotely or hybrid and accommodate any time zone work schedule.

Paul H Johnson is the founder, CEO and principal consultant serving clients.

Service Areas

Sterling Development LLC can be trusted to complete projects timely, effectively and efficiently in the areas listed below.

• Computerized System Validation for a wide range of non-product systems (for example: laboratory analytical systems, enterprise resource planning systems, computerized manufacturing equipment, software to automatically control the flow of water through Southern California)
• Computerized System Implementation
• Quality Management Systems for computerized systems (validation master plan, procedures for computerized system validation, supplier qualification)
• Validation Assessment for computerized systems
• Data Integrity Assessment per ALCOA++ data integrity attributes
• 21 CFR Part 11 Compliance Assessment
• Writing Procedures and Work Instructions for the use, administration and maintenance of a computerized system
• Risk Assessment for computerized system use
• Data Migration
• Business Analysis and Business Process Mapping for computerized systems
• Corrective Action / Preventive Action (CAPA) for computerized systems
• Project Management for projects in the areas listed above

About Paul Johnson

Paul Johnson was born in Philadelphia and studied physical chemistry at Pennsylvania State University (BS) and University of California, Berkeley (MS).  He did hazardous waste site investigations for the US EPA Superfund Program and managed a mobile lab that performed analyses of soil, water and air samples.  He invented miniature gas chromatography devices micromachined from silicon wafers that were patented and tripled sales for Microsensor Technology, which caused Hewlett-Packard (now Agilent) to buy Microsensor Technology.  In 1999, he completed a fast-track program in computer technology and got a job at Merck managing an Oracle database of drug stability data.

Since about 2000, Paul Johnson has been engaged in the implementation and validation of computerized systems, primarily for medical products companies.

Paul Johnson is a PMI Certified Project Management Professional, ASQ Certified Software Quality Engineer, and ASQ Certified Manager of Quality and Organizational Excellence.

Paul Johnson established Sterling Development LLC in 2015.  He is the principal consultant serving clients.

As a consultant, Paul Johnson provides services to medical products industry clients for all aspects of computerized system implementation and validation for regulatory compliance.

See Paul Johnson resume.

Resume – Paul Johnson