FDA-regulated companies in pharmaceutical, biotechnology, medical device, blood and other life sciences industries within the GxP industry environments are required to comply with 21 CFR Part 11 for electronic record keeping.
FlashLink Data Manager desktop application is a comprehensive data management tool for use in conjunction with In-Transit FlashLink Data Loggers + our patented Shadow Log^™ Technology.

User-defined alert/reminder messages can be "attached" to each key software function. Drastically reduce human operational error and costly training time.
Company standard operating procedure can be easily defined for each key software function!

Full individual and group audit trails readily available for FDA and internal inspection
Logger data authentication safe-guards against data manipulation / tampering.

What are the benefits of using FlashLink Data Manager? Compliance is just one of the benefits gained. Implementing electronic signatures and electronic records as specified by 21 CFR Part 11 has many other benefits including:

Better Quality Control – Reduce costs associated with product loss

Improved Efficiency – Search and find documents in a fraction of the time

Risk Avoidance – Be prepared for FDA inspections and minimize human error

Faster Time to Market – Reduce the costly time delays associated with lengthy approval cycles

Individual user’s software access rights can be customized depending on user's responsibilities and the company SOP.

Cost of noncompliance
With the increasing number of 483s and warning letters, the cost of noncompliance continues to be very high. Organizations that are deemed by the FDA as out-of-compliance, or those who incurred consent decrees are spending significant finanical and human resources in remediation. As FDA audits continue, 21 CFR Part 11 compliance should be a top priority, especially in regards to cGxPs.

We can help...
Please call 1-800-962-6776 for more information.