The laboratory lifecycle of data includes a step that is not always appreciated by all scientists but nonetheless is very important in maintaining a compliant operation. Archiving… the A word.
Creation and Collection → Data Analysis/Organization → Archiving → Destruction
I recently spent time reviewing the guidelines surrounding the archiving process for data created in a contract research organization. The main takeaways are to ensure and test the continued ability to retrieve data, ensure continued readability of data in a human readable format and conversion of data to a different format or transferring data to another system may be required to ensure accessibility.
When establishing your archiving policies and procedures it is important to determine the scope including all possible instruments that are collecting and being used in analysis of regulated data. Archiving should be discussed and considered upfront, especially in the case of CROs whose client’s may want to retain all data and be responsible for all archiving requirements or may put that onus on the CRO. Regardless of who ends up being responsible, determining initially with each client, mapping out data retention responsibilities and requirements can save time and avoid the potential of operating with a compliance gap. Once the instrumentation scope is determined it becomes easier to map solutions to maintaining compliance. It may also be easier to consider and treat all data collected and analyzed as regulated data so you don’t have to worry about delineating between regulated and non-regulated data which can be blurry, typically instruments are used in laboratory settings for both.
When determining the archival scope it is important to consider what data will be generated. Paper printouts or static records can be appropriately archived if the instrument does not generate dynamic data and if the static record can be considered a complete copy of the original record or a true copy of it. Dynamic records are generated from certain types of laboratory instruments and are typically electronic records. In order for these records to be complete and able to be retrieved and reconstructed, all raw data, meta data, e-signatures and associated hardware and software need to be migrated to a separate dedicated electronic archive system or a defined archive area that is explicitly marked or logically separated and only under the control of the “archivist”. It is important to ensure the preservation of records so everything remains complete and retrievable during the entire defined retention period. Appropriate equipment for use in rendering the records into readable formats must also be maintained. If original records are in danger of being lost or destroyed, migration is an option. To ensure complete and accurate migration of original records, the process should be documented and validated.
Documentation is key. Establishing clearly defined documentation requirements and procedures for archival, retrieval and migration of data is paramount to running a successful and compliant program. Every operation is different, so it is also important to make it work for your specific needs and facility.
Author: Josephine Oldham, President, SpecLine Consulting, Inc.
21 CFR Parts 16 and 58 Good Laboratory Practice for Nonclinical Laboratory Studies
EU Guidelines for GMP – Annex 11 and Annex 15
OECD Series on Principles of GLP and Compliance Monitoring: Computerized Systems and Archives
USP 37: 1058 Analytical Instrument Qualification
GAMP Electronic Data Archiving