Our archiving services, provided in conjunction
with our laboratory function, provide regulatory compliant storage for a period
of 2 years after study completion.
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Program Management
FDA regulations require that
study materials be retained for two years following the approval for a research
or marketing permit, or five years following the submittal date for the results
of studies for New Drug Applications (NDAs) or Applications for Investigational
Device Exemptions (IDEs). EPA regulations require the retention of study
materials from pesticide toxicology studies for as long as the product is on the
market.
In the case of compounds or
materials regulated by the Toxic Substances Control Act, the materials must be
stored a minimum of ten years. In order to meet individually tailored archiving
requirements within the industry, we provide additional contractual services
beyond Calvert’s standard two-year time period.
Inspection Procedures
The archive facility and
procedures are inspected annually by Calvert’s in-house Quality Assurance Unit
as well as sponsor driven audits. Internal inspection procedures are performed
to ensure accuracy of inventory and appropriate packaging for long-term storage.
Calvert archive personnel inspect all wet tissues in storage every three
years. A sample of blocks, slides and data are examined individually on an
annual basis to confirm archival quality. In addition, the archive is open to
inspection by regulatory agencies.
Reporting Capabilities
Our records management tracking
system is able to provide a variety of reports according to your needs. Example
reports include the following: Total Files Archived
- Individual File Inventory
Consulting
Calvert is always available to
assist clients in establishing and maintaining quality records retention
programs. Our Document Center Coordinator is an active member of ARMA
(Association of Records Managers & Administrators).
Contact Information
Scott Technology Park
100 Discovery Drive
Olyphant, PA 18447
(570) 586-2411
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