Archiving
Calvert Archiving Services assist clients with data storage and regulatory compliance needs. Calvert Archiving Services is guided and supervised by Calvert Holdings (the parent company of Calvert Laboratories).
Program Management and Capabilities
Calvert Archiving Services consistently serves the pharmaceutical, biotech, and agro/industrial chemical industries, and they have successfully withstood regulatory scrutiny. The services of this operation are in full compliance with the Good (Pharmaceutical) Practice Regulations of the DHHS/Food and Drug Administration. Additionally, Calvert Archiving Services adheres to the Good Laboratory Practices of the United States Environmental Protection Agency, 40 CFR Part 160, 40 CFR Part 792.
The need for this type of service is clear when discussing regulatory compliance issues and the requirements for retention of study data. FDA regulations require that study materials be retained for two years following the approval for a research and 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). Additionally, 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 of materials regulated by the Toxic Substances Control Act, the materials must be stored a minimum of ten years.
To help clients meet these requirements, Calvert Archiving Services, provided in conjunction with Calvert laboratory function, provides complimentary regulatory compliant storage for a period of two years after study completion. In order to further meet individually tailored archiving needs within the industry, Calvert also provides additional contractual services beyond the standard two year time period.
The archiving services at Calvert are managed by Terri Gyza, Document Center and Archive Manager (Archivist and affiliate member of the Society of Quality Assurance) and Whitney Higgins, Quality Assurance Auditor (Deputy Archivist). These coordinators effectively communicate with and between study directors, histopathology providers, analytical services, and sponsors to insure proper receipt and disposition of data. Document information is stored and maintained in a secure database to assure ease and rapidity of retrieval and delivery. Consistent quality and attention to detail in this area is the cornerstone of Calvert Archiving Services.
Facility
Calvert Archiving Services maintains approximately 10,000 cubic feet of storage space. The facility is located off the Calvert Laboratories, Inc. premises, and it is conveniently situated with close proximity to both Philadelphia, New Jersey, and New York.
This space is located in a building constructed of brick and concrete block, and entry is restricted by a secured entry access system. Archived data is protected by a central security system, fire suppression system, and temperature/humidity control systems. Calvert facility engineering and metrology staff members perform regularly scheduled maintenance checks on all systems to insure optimal working condition at all times.
Inspection Procedures
The archive facility and procedures followed by the document coordinators are inspected annually by Calvert’s in-house Quality Assurance Unity. Sponsor driven audits are conducted upon request to insure that all client questions are addressed, and regulatory agencies are welcome to inspect this facility at any time. Internal inspection procedures are also performed to ensure accuracy of inventory and appropriate packaging for long-term storage. Calvert archiving personnel inspect all wet tissues in storage every three years, and they individually examine a sample of blocks, slides, and data on an annual basis. All of this is done to confirm that the archival quality is of the highest standard for clients.
Consulting
Our staff is always available to assist clients in establishing and maintaining quality records retention programs. Additionally, the records management tracking system is able to provide a variety of personalized reports specific to client’s individual needs. For more information about these reports or the types of personalized archiving services that Calvert can provide, please contact us.
