Record Retention.Part

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. 

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). 

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. 

Record Retention The FDA intends to exercise enforcement discretion with regard to the Part 11 requirements for the protection of records to enable their accurate and ready retrieval at any time throughout the records retention period. 

Part 11 defines how electronic records must be managed. The retention requirements of such records are contained in the applicable predicate regulation. Table 22-1 refers to some of the sections in the predicate regulations or guidelines that specify record retention requirements. 

In some cases, it may be prudent to obtain a certified copy for the subject s clinical trial file. For example, if the records are not owned by the investigator or under his or her control, such as patient medical records held by the hospital, depending on the hospital s archiving procedures it would be advisable to obtain certified copies for the clinical trial file in case the hospital loses, misplaces, or intentionally destroys the documents under an established record retention schedule. This is all part of CQA s oversight role regarding the appropriate transfer and authentication of raw data and source documents. 

You may now submit ANDAs in electronic format in place of paper. We have placed the ANDA on public docket 92S-0251 as a submission acceptable in electronic format as allowed under 21 CFR Part 11. It should be noted that Part 11 requires that data sets provided in electronic format and used in the review process meet the requirements for archiving, i.e., protection of those records to enable their accurate and ready retrieval throughout the records retention period. 

Scientific data management requires a complete audit trail to be a part of the application, which must be electronic, always on, unchangeable, and able to work automatically without user intervention. The audit trail is linked to the record being changed and must be kept for the full record retention time. 

For other Part 1904 provisions (for example, industry exemptions, reporting of fatalities and hospitalizations, record retention, or employee involvement), State-Plan State requirements may be more stringent than or supplemental to the Federal requirements, but because of the unique nature of the national recordkeeping program. States must consult with and obtain approval of any such requirements. 

Additionally, with the inclusion of computers as part of an instrument, mathematical manipulation of data was possible. Not only could retention times be recorded automatically in chromatograms but areas under curves could also be calculated and data deconvoluted. In addition, computers made the development of Fourier transform instrumentation, of all kinds, practical. This type of instrument acquires data in one pass of the sample beam. The data are in what is termed the time domain, and application of the Fourier transform mathematical operation converts this data into the frequency domain, producing a frequency spectrum. The value of this methodology is that because it is rapid, multiple scans can be added together to reduce noise and interference, and the data are in a form that can easily be added to reports. 

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. 

Electronic record/electronic signature. Currently, requirements concerning ER/ES according to FDA 21 CFR Part 11 cannot be implemented with Excel spreadsheets. Concerns include file protection, security, user access, audit trail, version retention, file deletion or erasure, electronic signature(s), and network issues. These can be resolved using a hybrid system, an electronic version of the spreadsheet and an approved hard copy. After data entry (and subsequent to... 

Use the same instrumental conditions to analyze the samples from part A. The samples will contain a mixture of fatty acid methyl esters, so several recorder peaks will be obtained. Do not inject a second sample until you are sure all the fatty acids have been eluted from the first sample. Determine the retention time for each standard FAME and for each FAME in the unknown samples. Retention time is the time interval between injection of sample and maximum response of the recorder. 

One of the most important procedures to be developed and followed is the administration and retention of electronic records. Part 11 requires the retention of electronic records in electronic form. For regulated systems in which electronic signatures are not implemented (hybrid systems) the electronic record requirements (Sub-Part B) in Part 11 are applicable, and the electronic records are maintained and retained in electronic form for the period established by the predicate rule. 

An element beyond the scope of the model is the retention of electronic records, but the model can be used to verify and validate the implementation of the system(s) that will hold these records. A subset of the above requirements are applicable to hybrid computer systems,1 and the implementation of these requirements have been discussed in other articles.2,3 The fundamental requirements that Part 11 establishes are as follows ... 

It is a requirement of Part 11 that all data produced from electronic files is in human readable form and that true copies are available. In the case of data retirement, the planning must include the technologies needed to support the retired records, for the duration of the retention period required in the applicable regulations. If electronic records which have been retired need to be accessed in the future for review, the data and the application source code need to be readily accessible. The qualification of any... 

Equipment to measure, proportionally divert, and collect the surface runoff was installed at the end of the irrigation ditch-draining test plot. The measuring apparatus consisted of an up-channel and apron, Parshall flume, stilling well, and water level recorder. A flow-splitting device was attached to the downstream side of the flume. One third of the flow was diverted to a settling tank where it was sampled. A 3-hour retention time was allowed for the water-borne silt to settle. A proportional part of the settleable silt was collected for analysis. 

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

IPC-generated data and records subject to regulation by 21 CFR Part 11 are required to be retained for a defined retention period, typically for a number of years beyond the expiry date of the product. The retention period is to be determined by reference to predicate rules and a risk-based assessment of the value of the record over time. 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

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