Risk

Risk Management greatly reduces inefficiencies resulting from unanticipated operational disruptions.

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Compliance

For regulated organizations, quality problems & non-compliance have serious consequences

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Quality

An integrated and effective quality system is key to improve efficiency & compliance in manufacturing operations.

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Welcome to Pilgrim Software


Living a Quality Corporate Culture

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…

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Quality is Everyone’s Job

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,…

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Crafting a Quality Culture

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…

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Measuring the Success of Training and Competency

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…

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Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

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…

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FDA’s New RTA Policy Is Just What Some Companies Need

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…

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Get with the (Management) Program…for a Change

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…

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