Welcome to Pilgrim Software

Living a Quality Corporate Culture
Kari Miller, Sr. Director of Industry Solutions & Product Management
A culture of quality requires teamwork. Teamwork is the natural result of working in an environment where people feel they are part of something bigger…

Quality is Everyone’s Job
Kari Miller
Senior Director of Industry Solutions and Product Management
Pilgrim Software, Inc.
Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness,…

Crafting a Quality Culture
Kari Miller
Senior Director of Industry Solutions and Product Management
Pilgrim Software, Inc.
Most people in industry are familiar with W. Edwards Deming, Joseph Juran, Jim Harrington, and others whose ideas are usually grouped under the term…

Measuring the Success of Training and Competency
Konyika Nealy, Director of Quality Assurance, Pilgrim Software
According to 21 CFR Part 211 Subpart B, Section 211.25 (Personnel Qualifications),
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have…

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk
Mark Crawford
Sometimes the most important step in a successful product launch is knowing where the documents are—getting delayed by not being able to find the documents the FDA insists on seeing (or worse, having…

FDA’s New RTA Policy Is Just What Some Companies Need
Mark Crawford
The FDA’s updated Refuse to Accept (RTA) policy for 510(k) applications that lack required documentation is now in effect. The draft version was issued last summer.
This new policy outlines an early review…

Get with the (Management) Program…for a Change
Konyika Nealy, Director of Quality Assurance, Pilgrim Software
Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is…
Recent Posts
- Living a Quality Corporate Culture
- Quality is Everyone’s Job
- Crafting a Quality Culture
- Measuring the Success of Training and Competency
- Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk
- FDA’s New RTA Policy Is Just What Some Companies Need
- Get with the (Management) Program…for a Change
- Don’t Guess on Variation and Corrective Action
- Will the Medical Device Tax Go over the Fiscal Cliff?
- Time For SaaS?
Pilgrim Software News
- Pilgrim Software Launches Life Science Industry’s First Intelligent Solution for Global Complaint Handling and Adverse Event Reporting
- Pilgrim Software eMDR Expert to Address Medical Device Industry: "Promises and Pitfalls: "The Art of Preparing and Implementing eMDR”
- Pilgrim Software to Exhibit at 25th Annual DIA EuroMeeting
Most Used Tags
Advamed audit CDRH change management clinical sponsors compliance Continuous Improvement corrective action document management electronic regulatory reporting electronic signature eletronic medical device reporting FDA FDA Guidance food and drug administration food safety GMP HACCP ISO ISO 9001 Lean life sciences manufacturers Medical device Medical Devices performance PMA PMA Procedure QMS quality Quality Management RCA recalls Regulatory regulatory standards risk Risk Management safety and quality FDA regulations Safety requirements Six Sigma SOPs Supplier Quality Management supply chain training validation




