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Validation, compliance and documentation

Stories that report on the information and documentation involved in complying with verification, qualification, and validation guidelines and regulations from agencies and organizations, including quality-related issues.

Validation insights for medical device packaging

Medical device packaging validation can be confusing, so here are a few helpful resources to guide your efforts....

Compliance Checklist for FDA-regulated Companies Now Available from Dickson Company

Worldwide food and drug companies selling to the U.S. market can now obtain a free FDA 21 CFR Part 11 Checklist to ensure full regulatory compliance of their environmental monitoring practices....

Compliance risks and package validation mistakes

Examining common medical device package development/validation errors, and five compliance risks facing life-science firms....

Manage your validation missions with GxP Manager*

As a Validation Manager, you know the validation team is usually the last on the scene when money and time have run out!...

First DataBank Joins Health 2.0 Accelerator Consortium and Partners with PharmaSURVEYOR*

First DataBank, a leading provider of integrated drug databases for the healthcare industry, today announced that it will join PharmaSURVEYOR and a growing list of "Health 2.0 companies" as participants in the Health 2.0 Accelerator, a consortium focused on promoting...

Inventory control software

• FastPic5® software for health care users provides improved tracking, validation, and traceability...

Outsert systems

• MV-08 (shown) is a single knife-folder system that folds evenly sealed outsert leaflets with up to 110 panels...

A change of course for pharmaceutical manufacturing

The FDA’s Quality-by-Design initiative holds potential to transform the pharmaceutical industry’s approach to drug development and manufacturing....

Health professionals express ESD concerns

During HealthPack 2009 in Memphis, several conference users and attendees outlined issues pertaining to static electri-city with packaging materials, electrostatic discharge (ESD)-protective compliant packaging, and electrostatic attraction (ESA) observations with packaging....

Machine vision inspection system

• IMprints™ CodeMatch enables pharmaceutical companies to begin building an e-Pedigree-compliant packaging line system • this addition to the IMprints Track & Trace Solutions suite provides a range of inspection tools for validation and verification of label information •...

Blister documentation package

• comprehensive Quality Documentation Package comes at no charge with every set of the company’s blister tooling • includes everything necessary for tooling validation, including inspection documents, material data sheets, and material safety data sheets • a similar package...

Bauer’s pharmaceutical handbook lends ‘Hall of Fame’ packaging perspective

Professionals and students will benefit from an informative research tool now available for the healthcare packaging community....

ESD-safe packaging considerations for microprocessor-driven medical devices

Medical and pharmaceutical professionals must adhere to protective measures in safeguarding ESD-sensitive devices against electrostatic discharge....

GlaxoSmithKline, Abbott, and contract packaging panel highlight Pharmaceutical Packaging Forum

The third-annual Pharmaceutical Packaging Forum (PPF) will deliver information you can use on pharmaceutical package design, increasing quality and productivity, patient compliance, strategies to combat counterfeiting, how to increase packaging line profitability, and will include a contract packaging panel, and...

Three testing tips for medical device packages

Sterile medical device package testing is a requirement for compliance to ISO 11607 "Packaging for Terminally Sterilized Medical Devices", Part 1: Requirements for materials, sterile barrier systems and packaging systems, and Part 2: Validation requirements for forming, sealing and...

Cost pressures cloud healthcare packaging's future

Mounting financial pressures top a list of issues driving the pharmaceutical, biologic, and medical device sectors. In an exclusive interview, Freedonia senior healthcare consultant Bill Martineau discusses where packaging fits into these issues. Even before the recent global financial...

Packaging vaccines for pandemic flu or bioterrorist attack: Are we ready?

A Congressional blue-ribbon panel believes, "Terrorists are likely to use a weapon of mass destruction somewhere in the world in the next five years," according to a Dec. 2 CNN report. Biological weapons are more readily available than nuclear...

Podcast: Serialization matters: What pharmaceutical packagers need to know

In this exclusive podcast from Pack Expo 2008, Anne Marie Mohan, senior editor of Packaging World, speaks with Bruce A. Harder, Systech International's director of business development. Harder provides an overview on what constitutes a complete serialization solution and...

CHPA issues voluntary pediatric cough and cold label updates

"Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral pediatric cough and cold medicines with new labels and packaging. As with other OTC [over-the-counter] labeling changes in the past, FDA [U.S. Food and...

Seven essentials for successful medical package design and validation

Individuals responsible for medical device packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end user without incurring defect or risk to patient safety. In this...

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