No. Firstly 21 CFR part 11 is only binding for companies in the United States that use electronic data and/or documents in lieu of paper in their GxP processes. Outside the US, the rule applies in a similar way to all companies that develop or produce products under GxP for the US market. The fact however, that the USA is the most important pharmaceutical market, has made 21 CFR part 11 a quasi global standard within the industry.

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Is there a way to avoid the need for 21 CFR part 11 compliance?

If you operate within the USA or produce for the US market, the only way to avoid 21 CFR part 11, is to resort to an all-paper-based documentation and archiving of GxP relevant data and processes. For electronic data, compliance to 21 CFR part 11 is mandatory.

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From what date on must GxP operations comply with 21 CFR part 11?

Rule 21 CFR part 11 has been in effect since August 20, 1997. However a final FDA guidance for industry about the implementation was missing until 2003. Recently the FDA has been stepping up its efforts to monitor compliance during audits and an increasing number of “warning letters” have been issued.

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Is it true that 21 CFR part 11 was recently withdrawn by the FDA?

No. In February 2003 FDA withdrew all prior draft guidance documents dealing with different aspects of 21 CFR part 11 implementation and announced to review the rule itself and the draft guidance. In August 2003 a final Guidance for Industry, Electronic Records; Electronic Signatures — Scope and Application was issued and the Rule itself remained unchanged and valid. Since then the FDA is increasingly inspecting for 21 CFR part 11 compliance within the framework of its normal GLP and GMP inspections.

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Can I become compliant by using 21 CFR part 11 compliant software?

No. Software alone cannot render a laboratory or manufacturing operation part 11 compliant. Full compliance entails a number of steps including organizational measures, validation, policies & procedures and user training. Software like BM-Windream can supply the core technical features necessary for compliance like computer generated audit trails, access control, life cycle and electronic signatures. But only if and when hardware, software and operational procedures ensure that all electronic data are secured against loss, corruption, or unauthorized changes, a (validated) system can be viewed as part 11 compliant.

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According to 21 CFR part 11, am I forced to change from paper to electronic documentation?

No. 21 CFR part 11 applies only to data and documents that are required in compliance with predicate rules (GLP, GCP, GMP) AND that are generated and maintained in electronic form in lieu of paper. This means that paper records can still be maintained as usual. In this instance, however the paper is the only valid form of a particular document. Electronic copies of data or a document kept in parallel may not be used in the GxP process. If electronic data or documents are used in the GxP process, then compliance with 21 CFR part 11 is mandatory.

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If paper-based documentation is still allowed, why change to electronic documents?

Using electronic data and document management in GxP processes instead of paper holds great potential to save time and money. Most data are originally generated in electronic form already. Time and resources needed for printing, organizing and archiving all these data on paper afford a great deal of time and effort in most laboratories. The physical distribution, routing and retrieval of data and documents in R&D or GMP environments takes up a considerable amount of time, often from skilled personnel. The ability of electronic data management systems to store, archive and retrieve documents according to criteria such as Batch No., Project No., Instrument ID, Operator, SOP No. etc. - instantaneously and with a mouse click - boosts productivity and saves cost at the same time.
In order to realize such time and cost benefits, a data management and archiving system needs to be able to handle all electronic file formats, integrate easily with existing equipment, software and IT infrastructure and ensure full 21 CFR part 11 compliance. BM-Windream was developed with the objective to combine all these advantages in an easy-to-use and cost-effective solution.

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What can I do with my legacy systems that run non-21 CFR part 11 compliant software?

Virtually all existing PC-controlled instruments can integrate with BM-Windream. Data are stored directly in BM-windream, which supplies all the technical controls (access control, audit trail, e-signature etc.) for 21 CFR part 11 compliance. BM-Windream can handle binary and proprietary formats from any application. Please contact us, if you have questions about a specific system.

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Does 21 CFR part 11 mandate that all data are electronically signed?

No. When using electronic data and documents according to 21 CFR part 11, only such documents need to be electronically signed, that would also require a signature according to the 'predicate rules' (GLP, GCP, GMP) if paper records were used. Usually in GxP operations, many more paper records are signed than are explicitly required by the predicate rules. Using paper records, a signature is often used as an easy way to document a paper trail. Electronic systems like BM-Windream automatically track the fate of each data file or document through the computer generated audit trail. Thus e-signatures need only be applied if and when the applicable predicate rule explicitly calls for a signature. According to 21 CFR part 11, even handwritten signatures (on paper) can be employed to sign electronic documents. Users who want to employ this hybrid method must however ensure that the paper record of the signature is unequivocally and irreversibly linked to the respective electronic record.