EM for Windows™ Compliance Pack™ was developed and validated
in cooperation with a major US pharmaceutical manufacturer.

Do You Need Compliance Pack?

GLP compliance is required for all nonclinical pharmacological and pharmacokinetic studies designed to test drug safety and efficacy; GCP compliance is required for similar clinical studies. Additionally, the US Food and Drug Administration (FDA) mandates that all FDArequired records stored in electronic format in place of or in addition to a paper record must be compliant with 21CFR Part 11. If you are planning to use ERG, EOG, or VEP electronic records as part of a drug study or clinical trial whose results will be submitted to the FDA or other government agency, you should consider the EM For Windows Compliance Pack.

Features

EM For Windows Compliance Pack provides the safeguards necessary for LKC's proprietary EMWin software to be GLP, GCP, and 21 CFR Part 11 compliant. However, compliance with these principles requires more than just a software package. The user must still develop and follow strict usage protocols, assure training of individuals, etc. The software ensures that the correct test protocols will be followed throughout the course of the study, that raw data will be preserved, that manipulated data or procedures will be appropriately documented, that all records will be properly archived, and that access to data can be audited.

Even if you are not planning to electronically submit clinical trial data to the FDA, the Compliance Pack can provide invaluable internal controls and traceability for your GLP or GCP studies.

EM For Windows™ Compliance Pack Specifications

Provides GLP/GCP and 21 CFR Part 11 electronic records compliance to your UTAS or EPIC system running LKC’s EM
for Windows™ software.

• Separate management of GLP/GCP
  and non-GLP/GCP studies
• Preset selectively-alterable protocols
• Protocol-specific demographic templates
• Justification required for trial repeats
• Auto-save option
• Data encryption controlled by network server

• Four user authorization and privilege levels
• Login required
• Audit trails identifying user and event
• Time and date stamps stored and displayed on printouts

• Step Automation: Protocols with predetermined time intervals between steps

Resources (PDF):
Compliance Pack Brochure
Compliance Pack Manual

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