Tag Archives: GxP

Raw Data Management – Challenges for the Pharmaceutical Industry

arivis and BioMedion focus on developing software for the pharmaceutical industry. One of our areas of core competence is realizing Enterprise Content Management projects for managing raw data, especially device data in a GxP environment.

Our customers are confronted with a raft of challenges when it comes to managing their device data. Many laboratory systems do not meet the requirements of 21 CFR Part 11 (despite labels which often make claims to the contrary). They have considerable shortcomings in terms of user management, audit trails and protecting generated data against unauthorized modification. In addition, there is often no robust strategy that makes it possible to restore data that has been archived for many years.

Regulatory requirements are also becoming more onerous. In the latest Guidance for Industry “Data Integrity and Compliance with CGMP”, the FDA makes it unmistakably clear that the hitherto available option of declaring laboratory data in printed form as raw data is no longer valid in the field of complex systems (see also http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf, especially III.10).

Inspections are therefore increasingly focusing on computerized systems. This impact is reflected in current warning letters:


BBT Biotech GmbH          http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502347.htm

Chongqing Lummy Pharmaceutical Co., Ltd. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508291.htm

Sandoz International GmbH http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474013.htm

We deal with all the questions thrown up by this guideline and the warning letters. How can device data be rationally archived, indexed and reprocessed? How can the reason for modifying data be logged even in systems that do not actually support this function? How can an audit trail be represented, even for laboratory equipment that was not specially developed for the pharmaceutical industry? How can proprietary manufacturer-specific files be read and made sense of many years in the future if the laboratory application that was originally used is no longer available?

During the webinar we aim to examine the practical consequences of the requirements defined in the latest draft of the above-mentioned FDA Guideline and to present BM-windream as a possible solution to the problems outlined above.

Paul Daniel, Senior Regulatory Expert, VAISALA

Paul Daniel, Senior Regulatory Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries.

Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820.

An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor’s degree in biology (with honors) from the University of California, Berkeley.

What is your favourite thing about presenting on webinars?

It is an opportunity for me to give something back to the professional Life Science community which has given me a rewarding career in Validation.

What are you looking forward to explaining to the audience?

Mean Kinetic Temperature (MKT) is a really interesting topic. There is a deep and engaging story in the history of MKT that is intertwined with the history of HVAC and monitoring technology, and heavily influenced by ongoing regulatory changes in Good Distribution Practice. I am looking forward to sharing this story, so that we can see how our understanding and use of MKT has changed over the last 40 years, and hopefully, have a better idea of where this unique tool can be used effectively today.

What attracted you to the industry and what do you enjoy most about working at VAISALA?

I became involved in Pharmaceutical Validation because I was good with details, and I was seeking an industry where my work would have a direct link to improving quality of life. I joined Vaisala over 4 years ago because I thought it would allow me to be more effective at influencing positive change within my industry. I really like Vaisala because this company is dedicated to making the world a better place, one measurement at a time. Our mission statement – Observations for a Better World – conveys this idea. And, I really enjoy working with excellent people, in an established international company, that continues to create technology that changes the world. I may work in the narrow niche of Temperature Monitoring for Pharmaceuticals and Medical Devices, but Vaisala is involved in a much wider scope of enterprise that includes weather, road safety, interplanetary exploration, and preserving cultural treasures. I can’t imagine a more exciting place to work!

What is your favourite holiday destination?

I don’t have a favourite. But if you gave me two-weeks off and an expense account, there are a few places you would likely find me; high in the Colorado mountains fly-fishing an isolated stream, riding a mountain bike on remote single-track trails in the Pyrenees, or asleep in the sun on a beach in Mexico.

How did you spend the Easter holiday?

Easter was spent with friends and family, enjoying the return of spring, sitting in the sun, and talking about our hopes for the coming year.

Join Vaisala’s webinar with Paul on “Mean Kinetic Temperature in GxP Environments”. Register here.