Record retention

The final audit report, action plans, progress reports, and any closure report should be retained by the facility based on the facihty record retention pohcy. Typically, these items will be retained until future audit documentation replaces them. In some cases, audit records are retained for the life of the plant. 

Production part approvals, tooling records, etc shall be maintained for the length of time that the part is active for production plus one calendar year, unless otherwise specified. This requirement, although removed, is implicit in the new requirement for record retention. However, the note on including purchase orders as quality records is removed, implying that they are not considered quality records but are documents and retained until obsolete. 

Disposition in this context means the disposal of records once their useful life has ended. The requirement should not be confused with that on the retention of records. Retention times are one thing and disposal procedures quite another. 

The standard requires the retention times of quality records to be established and recorded. The supplementary requirements extend the records retention requirements to quality system related documents and records to satisfy regulatory and customer requirements as a minimum. 

Procedures and controls shall include protection of records to enable their accurate and ready retrieval throughout the records retention period. 

What is the relationship of the single file to the database Demonstrate the functionality to accurately and readily retrieve archival records throughout the record retention period (e.g., backup and restore or archive/ retrieve or other). Include ... 

Are records protected during record retention period Accessible by database commands, SQL, etc. ... 

The archiving of electronic data poses more specific challenges. GLP requires records retention and retrieval of archival records. Since software used for the creation of electronic records is upgraded at a rapid pace, the requirement of retrievable archived records can be difficult to comply with. Even when stored on electronic media, the records have to comply with the records retention period and be retrievable. The collection, storage, and retrieval of electronic records should address all GLP aspects, including environmental conditions to ensure the integrity of the media. 

Retention of historical information must be done in accordance with the company s record retention policy, where one exists. However, in all cases, it is important to think in terms of when the information will be needed and not simply when it was created. 

Additional statements regarding records retention, which do not supersede the previous statements, are presented in the Retention of Records paragraph (EPA 160.195 and FDA 58.195). The period of time specific records must be retained is indicated here. 

For those records that remain subject to Part 11, enforcement discretion will be exercised with regard to Part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in the guidance and with regard to all Part 11 requirements for systems that were operational before the effective date of Part 11 (also known as legacy systems). 

Although it is the most important single document, the final published report is only a portion of the overall record of the investigation. A full and complete set of documents should be maintained for future reference. This systematic documentation package is sometimes referred to as the audit trail. It provides subsequent reviewers and investigators with the opportunity to understand the team s decisions and analysis more completely. The document set should contain lists of relevant files. All documents associated with the investigation should be preserved according to the company records retention plan. 

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

If the record retention requirements of 58.195 are inconsistent with those of any other part of 21 CFR, the other parts of 21 CFR wiU take precedence. 

The records and documents required to be maintained by the QAU are also subject to the record retention requirements of 58.195(b). Spokesmen for the FDA have stated on occasion that these QA records should be stored in the archives described in 58.190(b). This is an option that can be considered by the QAU, but there is no stipulated requirement in the GLP regulations for such storage. In fact, it could be argued that the requirement of 58.35(a) for the QA function to be independent of nonclinical laboratory study personnel militates against storage of QA records in the archives. 

Rather than storing summaries of training and experience and job descriptions in the GLP archives, a laboratory may elect to store such records together with other employment records (e.g., in the personnel department). If such alternative storage of these records is elected, care should be taken that the personnel responsible for the alternate records storage are aware of GLP record retention requirements. Be-... 

For the anal5d ical laboratory in the process of implementing GLPs, the standards will require some changes in record retention and storage pohcies. 

Food and Drug Administration investigators found generally acceptable performance in the archival and record retention areas as well as in the area of the physical facilities associated with animal care and laboratory operations. The lack of findings in these areas is encouraging, since it may be... 

Regardless of the laboratory s mission, managers are confronted with a common set of problems Increases in data volume from increased use of smart instruments and from increased testing and record retention requirements imposed by ERA, FDA, OSHA, and other regulatory agencies constantly rising operating and material... 

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