Security archiving

The sponsor and investigator, as appropriate, must retain all essential documents relating to the trial for at least 5 years after its completion. Documents should be securely archived, with restricted access to maintain subject confidentiality. Collectively, these constitute the Trial Master File, and facilitate any audit and evaluation of... 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

Procedures for the security, archiving, and recovery of software products are clearly... 

Security Secure management of data, i.e., un-retrievably destroyed or secure archiving of preserved integrity, depending on application)... 

Chemical structure registration is an important activity that is necessary for drug discovery. The structures that have been developed by a pharmaceutical company constitute the "crown jewels" of chemical information, and they must be properly and securely archived. The registration process usually involves the process of extracting, cleaning, transforming, and loading the data—sometimes term ECTL. 

National Security Archive (1970). The September 11th Source Books National Security Archive Online Readers on Terrorism, Intelligence and the Next War. Volume III BIOWAR The Nixon Administration s Decision to End U.S. Biological Warfare Programs. Available http //www.gwu.edu/ nsarchiv/NSAEBB/NSAEBB58/ RNCBW22.pdf. 

Quoted in Chang, Friends and Fnemies, p. 236. The Defense Department, predictably, was inclined to take a similarly pessimistic stance. See DoD paper, China as a Nuclear Power (Some Thoughts Prior to the Chinese Test), 7 October 1964, National Security Archive China Fiche Document [NSA Doc.] io. 

Memcon, 22 February 1972, Box 87, POF, NPM, p. 4. Transcripts of the 1972 Nixon—Zhou talks can also be accessed on the National Security Archive website . Fie repeated it in the penultimate meeting — memcon, 26 February 1972, Box 87, POF, NPM, p. 8. 

Kissinger to RN, My Trip to China, 2 March 1973, Box 6, PPF, NPM, pp. 2-3 (italics in original). I am grateful to William Butr of the National Security Archive for sharing the unsanitized version of this document, which he obtained through an FOIA request. 

National Archives Pacific Region [NA-PR], Laguna Niguel, CA Richard M. Nixon Pre-Presidential Papers National Security Archives [NSA], George Washington University, Washington, DC... 

The segregation of data and program memory is problematic with a single memory address field seen by the CPU (no memory access protection). Moreover, low-level communications media (IP protocol layer and management of communication cells, or other features of non-secure archival) are generally very resource intensive. 

This requirement supplements that for records to be readily retrievable but in addition implies a further requirement for security of records. After addressing the filing and storage requirements, you need to ensure that the records are accessible to those who will need to use them. This applies not only to current records but to those in the archive and any insurance copies you may have stored away. A balance has to be attained... 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

Is there a SOP for archive requirements and retention policies (Is the archived material indexed, is there document control and is it secure )... 

Archiving - placing files received and transmission logs into secure, long-term storage. 

It is essential that all data generated and any other records or samples (if possible) are retained so that they are available for inspection at a later date. This means that there must be a secure and properly controlled archive, with an archivist to maintain it. The archive will contain a copy of the Study Plan, quality assurance reports, records of staff including their curriculum vitae (CV) and training records. Access to the archive has to be strictly controlled, and any additions to or withdrawals from the archive must be logged (see also electronic records in Section 9.2.1.8). Such removal or additions can only be undertaken by stated personnel. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

Archive facilities should be provided for the secure storage and retrieval of raw data, final reports etc. 

Raw data and specimens need not be transferred to the archives until the completion of the study. Many lahoratories elect to transfer material to the archives as it is completed, however, to provide greater data security. The FDA has stated that all materials must he transferred to the archives within a reasonable period of time after the study director signs the final report. 

Managerial control is estabhshed and documented through a series of SOPs. These SOPs are system design, use, and control pohcy statements. They summarize procedures of system security, disaster recovery, normal use, data archive and backup, error response, documentation, testing, and other important aspects of control. 

Requirements for electronic records and electronic signatures [13-15] System security, data integrity, traceability, and data archive/retrieval. 

In addition to testing the system components, a test of software functionality would be performed to test the system software operation and electronic records and electronic signatures (ERES) compliance (security, data integrity, data backup, and archive). In order to test the software functionality, a predetermined set of instructions can be entered step by step into the system. The system responses are then compared to the expected outcomes of the instruction and any problems with the execution are determined. Some vendors will provide a standard set of data which can be processed by the system to verify the data-handling capability of the system. 

CFR Part 11 Electronic Records and Electronic Signatures (ERES) system security, data integrity and tracibilty, audit trail, and archive... 

All other validation sections, such as Design, Test, Security, Documentation for User and Training, Changes and Version Control, Archiving, Periodic Review, and Review and Approval, can be taken from the content uniformity example described earlier in the chapter. 

URS preparation Supplier audit and evaluation Qualification protocol preparation Qualification review and reporting System access security Backup, archiving, and retrieval System operation and management Contingency/recovery planning System maintenance Calibration... 

Bugayev couldn t believe there was a but. On the other hand, the way in had been far too easy. Zhelnin had assured him the Chervya had masked all identified surveillance with images pulled from Kronometr s own security-system archives. But the lack of guards and the empty corridors, even on these lower levels, was suspicious. 

All SLC documentation should be archived in an environmentally controlled facility that is suitable for the material being archived, and that is both secure and, where possible, protected from environmental hazards. A record of all archived materials should be maintained. 

After the computer system is put into operation and all appropriate validation documentation has been collected, as defined in the validation plan, the entire validation documentation package should be archived to ensure its safety and security. 

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