General overview about 21 CFR Part 11(2010制药工程国际论坛)
联邦法规：21CFR Part11“电子数据,电子签名,审计追踪” 中英对照(完整资料).doc
【最新整理，下载后即可编辑】PART 11 Electronic Records; Electronic Signatures第11款电子记录；电子签名Subpart A--General Provisions分章A 一般规定Sec. 11.1 Scope.11.1适用范围(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.However, this part does not apply to paper records that are, or have been, transmitted by electronic means.本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
FDA 21 CFR Part 11
FDA 21 CFR Part 11什么是21 CFR Part 11？21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名适用范围(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA 将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA用到，和服从于FDA的监管。
履行(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。
(b) 提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1) 符合条款的要求(2) 提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。
这个摘要将明确地识别出，何种类型文件或部分文件在没有纸制记录和FDA接收单位(举例来说，特定的中心，办公室，部门、分支机构)时的电子形式提交物是可接受的。
如果没有在公共摘要上明确出来，他们以电子形式提交给FDA接收单位的文件将不被认为是正式的；这种文件的书面形式将被认为是正式的但必须伴有电子记录。
21 CFR Part 11
21 CFR Part 11Overview21 CFR Part 11 is the FDA regulation which concerns the use of electronic records and electronic signatures. The emphasis of this regulation is to maintain the integrity of every electronic record and prevent possible falsification, copying or deletion of electronic records or electronic signatures.An electronic record is “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.”An electronic signature is “a computer data compilation of any symbol or series of symbols executed, adopted, or authorised by an individual to be the legally binding equivalent of the individual’s hand written signature.”The FDA require assurances that electronic records and submissions have the same integrity as paper records and they must be developed, maintained and used under circumstances that make it difficult for them to be inappropriately modified. Firms can decide for themselves the level of control required for each type of record they use within the frame of the company as long as it can be proved that the level of integrity cannot be endangered.The FDA chose to give firms maximum flexibility in determining:a)The circumstances under which management would have to be notified ofsecurity problems.b)The means by which the firms achieve the required link between an electronicrecord and an electronic signature.c)The circumstances under which extra security and authentication measures arewarranted in open systems.d)When to use operational checks to ensure proper event sequencing.e)When to use terminal checks to ensure that data and instructions originate form avalid source.The FDA stipulate that all persons involved in developing, maintaining and using electronic records/signatures must have the education, training and experience to perform the tasks involved although no specific examinations are required. The education, training and experience of each individual must also be documented.There are two types of system which the FDA have defined; …closed‟ systems and …open‟ systems.The definition of a …closed‟ system is an environment where system access is controlled by persons responsible for the content of electronic records on that system. An …open‟ system is an environment where system access is NOT controlled by persons responsible for the content of electronic records on that system. Both types of system are widely used in industry.Controls for Closed SystemsPersons using closed systems must ensure that the records cannot be altered, copied or reproduced in part and also that the signer cannot readily claim that the record is not a genuine record. The FDA also requires the availability of each of these records for review by the agency. The controls are to include the following:a)System validation which ensures accuracy, reliability, performance and ability toidentify invalid or altered records.b)The systems and users have the ability to generate accurate and complete copiesof records in both human readable (printout or display) and electronic form(floppy disk, tape) for review by the agency.c)Records must be protected against loss or damage. (Backup and restore facility,fire safe storage etc.)d)Limited access to the system through hierarchical use of username and passwordor limited number of licenses.e)Time stamped audit trails that independently record the date and time of operatorentries and actions that create, modify or delete electronic records. Recordchanges shall not overwrite or obscure previously recorded information. Audit trail information is required to be retained for at least as long as the subjectrecords and is also to be available to the FDA for review.f)Operational system checks are to be carried out and signed off by a responsibleperson to enforce permitted sequencing of events and steps as appropriate.g)Authority checks to ensure that only authorised individuals can access the system.h)Device checks which determine the source of an instruction or data.i)System training and experience validation.j)Signer accountability for actions initiated under their electronic signatures.k)Control over system documentation which includesi)Control of access to system O&M manuals.ii)Revision and change control procedures.Controls for Open SystemsPersons using open systems must have procedures in place that ensure the authenticity, integrity and confidentiality where appropriate of electronic records from the point of record creation to the point of the receipt by the system. The FDA also requires the availability of each of these records for review by the agency. The controls for open systems are the same as those provided for closed systems and may also contain additional measures such as document encryption and use of digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity and confidentiality.Electronic SignaturesElectronic signatures must contains the following:a)PRINTED name of the signer.b)Date and time when the signature was executed.c)The meaning associated with the signature i.e. Review, Approval, authorship etc. Electronic signatures must be unique to one individual and never reused and must also be easily identifiable with the individual. Electronic signatures are to be used with the intention that they are legally binding and may only be used by their genuine owners.Electronic Signature ControlsElectronic signature components and controls should employ two distinct components, i.e. username and password and no two individuals are to have the same combination of username and password.Electronic signatures must be periodically revised to prevent password ageing. Transaction safeguards must be in place which prevent unauthorised use of passwords and/or usernames. A safeguard which detects and reports in an immediate and urgent manner any attempts of use of unauthorised passwords and usernames must also be in place.Lost, stolen, missing or compromised tokens, identification cards or other similar devices that contain information pertaining to an individual must follow a procedure that immediately de-authorises the device and which issues a temporary or permanent rigorously controlled replacement.It is also a requirement that periodic testing of all devices that contain information pertaining to an individual is performed to ensure that the devices function correctly and have not been altered in an unauthorised manner.Signature/Record LinkingElectronic signatures cannot be edited, copied or transferred in order to falsify an electronic record.Guidance for IndustryPart 11, Electronic Records; Electronic Signatures -Scope and ApplicationU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)Center for Devices and Radiological Health (CDRH)Center for Food Safety and Applied Nutrition (CFSAN)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)August 2003Pharmaceutical CGMPsDivision of Drug Information, HFD-240Center for Drug Evaluation and Research (CDER)(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and Research (CBER)/cber/guidelines.htmPhone: the Voice Information System at 800-835-4709 or 301-827-1800orCommunications Staff (HFV-12),Center for Veterinary Medicine (CVM)(Tel) 301-594-1755/cvm/guidance/guidance.htmlorDivision of Small Manufacturers Assistance (HFZ-220)/cdrh/ggpmain.htmlManufacturers Assistance Phone Number: 800.638.2041 or 301.443.6597Internt'l Staff Phone: 301.827.3993orCenter for Food Safety and Applied Nutrition (CFSAN)/~dms/guidance.html.August 2003Pharmaceutical CGMPsTABLE OF CONTENTSI. INTRODUCTIONII. BACKGROUNDIII. DISCUSSIONA. Overall Approach to Part 11 RequirementsB. Details of Approach - Scope of Part 111. Narrow Interpretation of Scope2. Definition of Part 11 RecordsC. Approach to Specific Part 11 Requirements1. Validation2. Audit Trail3. Legacy Systems4. Copies of Records5. Record RetentionIV. REFERENCESGuidance for Industry1Part 11,Electronic Records; ElectronicSignatures -Scope and ApplicationI. INTRODUCTIONThis guidance is intended to describe the Food and DrugAdministration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).2This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA,3 have chosen tomaintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirementsset forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulati ons (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referredto in this guidance document as predicate rules.As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics,4 FDA is re-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result ofthat re-examination. This guidance explains that we will narrowly interpret the scope of part 11. While the re-examination of part 11is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements ofpart 11 as explained in this guidance. However, records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliancewith such predicate rules.In addition, we intend to exercise enforcement discretion and do not intend to take (or recommend) action to enforce any part 11 requirements with regard to systems that were operational before August 20, 1997, the effective date of part 11 (commonly known as legacy systems) under the circumstances described in section III.C.3of this guidance.Note that part 11 remains in effect and that this exercise of enforcement discretion applies only as identified in this guidance.FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.II. BACKGROUNDIn March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.After part 11 became effective in August 1997, significant discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. FDA has (1) spoken about part 11 at many conferences and met numerous times with an industry coalition and other interested parties in an effort to hear more about potential part 11 issues; (2) published a compliance policy guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures; and (3) published numerous draft guidance documents including the following:· 21 CFR Part 11; Electronic Records; Electronic Signatures,Validation· 21 CFR Part 11; Electronic Records; Electronic Signatures,Glossary of Terms· 21 CFR Part 11; Electronic Records; Elect ronic Signatures,Time Stamps· 21 CFR Part 11; Electronic Records; Electronic Signatures,Maintenance of Electronic Records· 21 CFR Part 11; Electronic Records; Electronic Signatures,Electronic Copies of Electronic RecordsThroughout all of these communications, concerns have been raisedthat some interpretations of the part 11 requirements would (1)unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit. These concerns have been raised particularlyin the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems.As a result of these concerns, we decided to review the part 11 documents and related issues, particularly in light of the Agency's CGMP initiative. In the Federal Register of February 4, 2003 (68 FR 5645), we announced the withdrawal of the draft guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records. We had decided we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the CGMP initiative. Then, in the Federal Register of February 25, 2003 (68 FR 8775), we announced the withdrawal of the part 11 draft guidance documents on validation, glossary of terms, time stamps,5 maintenance of electronic records, and CPG 7153.17. We received valuable public comments on these draft guidances, and we plan to use that information to help with future decision-making with respect to part 11. We do not intend to re-issue these draft guidance documents or the CPG.We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of that regulation. To avoid unnecessary resource expenditures to comply with part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of part 11. As mentioned previously, part11 remains in effect during this re-examination period.III. DISCUSSIONA. Overall Approach to Part 11 RequirementsAs described in more detail below, the approach outlined in this guidance is based on three main elements:· Part 11 will be interpreted narrowly; we are now clarifyingthat fewer records will be considered subject to part 11.· For those records that remain subject to part 11, we intendto exercise enforcement discretion with regard to part 11requirements for validation, audit trails, record retention,and record copying in the manner described in this guidance and with regard to all part 11 requirements for systems that wereoperational before the effective date of part 11 (also known as legacy systems).· We will enforce all predicate rule requirements, includingpredicate rule record and recordkeeping requirements.It is important to note that FDA's exercise of enforcement discretion as described in this guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which the extent of enforcement discretion, under certain circumstances, will be more broad). We intend to enforce all other provisions of part 11 including, but not limited to, certain controls for closed systems in § 11.10. For example, we intend to enforce provisions related to the following controls and requirements:· limiting system access to authorized individuals· use of operational system checks· use of authority checks· use of device checks· determination that persons who develop, maintain, or useelectronic systems have the education, training, and experience to perform their assigned tasks· establishment of and adherence to written policies that hold individuals accountable for actions initiated under theirelectronic signatures· appropriate controls over systems documentation· controls for open systems corresponding to controls forclosed systems bulleted above (§ 11.30)· requirements related to electronic signatures (e.g., §§11.50, 11.70, 11.100, 11.200, and 11.300)We expect continued compliance with these provisions, and we will continue to enforce them. Furthermore, persons must comply withapplicable predicate rules, and records that are required to be maintained or submitted must remain secure and reliable in accordance with the predicate rules.B. Details of Approach - Scope of Part 111. Narrow Interpretation of ScopeWe understand that there is some confusion about the scope of part 11. Some have understood the scope of part 11 to be very broad. Webelieve that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. As a result, we want to clarify that the Agency intends to interpret the scope of part 11 narrowly.Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generallynot consider persons to be "using electronic records in lieu of paper records" under §§ 11.2(a) and 11.2(b). In these instances, th e useof computer systems in the generation of paper records would not trigger part 11.2. Definition of Part 11 RecordsUnder this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronicformat (part 11 records or signatures):· Records that are required to be maintained under predicaterule requirements and that are maintained in electronic formatin place of paper format. On the other hand, records (and anyassociated signatures) that are not required to be retainedunder predicate rules, but that are nonetheless maintained inelectronic format, are not part 11 records.We recommend that you determine, based on the predicaterules, whether specific records are part 11 records. Werecommend that you document such decisions.· Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.In some cases, actual business practices may dictatewhether you are using electronic records instead of paperrecords under § 11.2(a). For example, if a record isrequired to be maintained under a predicate rule and youuse a computer to generate a paper printout of theelectronic records, but you nonetheless rely on theelectronic record to perform regulated activities, theAgency may consider you to be using the electronic recordinstead of the paper record. That is, the Agency may takeyour business practices into account in determiningwhether part 11 applies.Accordingly, we recommend that, for each record requiredto be maintained under predicate rules, you determine inadvance whether you plan to rely on the electronic recordor paper record to perform regulated activities. Werecommend that you document this decision (e.g., in aStandard Operating Procedure (SOP), or specificationdocument).· Records submitted to FDA, under predicate rules (even ifsuch records are not specifically identified in Agency regulations) in electronic format (assuming the records havebeen identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However,a record that is not itself submitted, but is used ingenerating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule andit is maintained in electronic format.· Electronic signatures that are intended to be the equivalentof handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures includeelectronic signatures that are used, for example, to documentthe fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).C. Approach to Specific Part 11 Requirements1. ValidationThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements for validation of computerized systems (§ 11.10(a) and corresponding requirements in § 11.30). Although persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements for validation.We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential ofthe system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs.For further guidance on validation of computerized systems, see FDA's guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide (See References).2. Audit TrailThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails (§ 11.10 (e), (k)(2) and any corresponding requirement in §11.30). Persons must still comply with allapplicable predicate rule requirements related to documentation of,for example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records.6 We recommendthat you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. We suggest that you apply appropriate controls based on such an assessment. Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation.3. Legacy Systems7The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11, under the circumstances specified below.This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system:· The system was operational before the effective date.· The system met all applicable predicate rule requirementsbefore the effective date.· The system currently meets all applicable predicate rulerequirements.· You have documented evidence and justification that thesystem is fit for its intended use (including having anacceptable level of record security and integrity, ifapplicable).If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance.4. Copies of RecordsThe Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject toinspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).We recommend that you supply copies of electronic records by:· Producing copies of records held in common porta ble formatswhen records are maintained in these formats· Using established automated conversion or export methods,where available, to make copies in a more common format(examples of such formats include, but are not limited to, PDF,XML, or SGML)In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible.You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.5. Record RetentionThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enabletheir accurate and ready retrieval throughout the records retention period (§ 11.10 (c) and any corresponding requirement in §11.30). Persons must still comply with all applicable predicate rule requirements for record retention and availability (e.g., §§211.180(c),(d), 108.25(g), and 108.35(h)).We suggest that your decision on how to maintain records be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment and a determination of the value of the records over time.FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format。
21CFR-part11-中文
制药行业美国FDA法规联邦法规21章第11款电子记录；电子签名分章A 一般规定11.1适用范围11.2 履行11.3 定义分章B 电子记录11.10 封闭系统的控制11.30 开放系统的控制11.50 签名的验证11.70 签名/记录连接分章C 电子签名11.100 一般要求11.200 电子签名的构成及控制11.300 识别代码和密码的控制分章A 一般规定11.1适用范围(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA用到，和服从于FDA的监管。
11.2履行(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。
(b) 提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1) 符合条款的要求；和(2) 提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。
21-CFR-Part-11介绍讲解
-Centralized Laboratory -Data Acquisition & Reporting -Remote Data Entry -Case Report Form Systems -Clinical Data management -Adverse Event Reporting -Clinical Supply Systems -Statistical Analysis Systems
系统验证
误区二
软件符合（compliant）21 CFR Part 11
体系的符合性，除软件外，还包括体系内硬 件、SOPs、人员培训和管理的对21 CFR Part 11 的符合性。
21
CFR Part 11概述
21 21
CFR Part 11内容解读 CFR Part 11应用
CFR = Code of Federal Regulations 美国联邦法规21章第11款 电子记录和电子签名 /scripts/cdrh/cfdocs/ cfcfr/cfrsearch.cfm?cfrpart=11
概述
1997年8月20日颁布实施的法规 适用于包括现有体系内所有FDA监管的工 作中的电子记录 电子签名和电子记录的准则：可信的和可 靠的 电子签名 = 手写签名 最低要求 / 防止假冒
绪论 正文
从企业反馈中整理出来的问题解释
法规本身
目录
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A--General Provisions § 11.1 - Scope. § 11.2 - Implementation. § 11.3 - Definitions. Subpart B--Electronic Records § 11.10 - Controls for closed systems. § 11.30 - Controls for open systems. § 11.50 - Signature manifestations. § 11.70 - Signature/record linking. Subpart C--Electronic Signatures § 11.100 - General requirements. § 11.200 - Electronic signature components and controls. § 11.300 - Controls for identification codes/passwords.
21 CFR Part 11 联邦法规21章第11款 主要规定内容涉及电子记录和电子签名
21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名适用范围(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA用到，和服从于FDA的监管。
履行(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。
(b)提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1) 符合条款的要求(2) 提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。
这个摘要将明确地识别出，何种类型文件或部分文件在没有纸制记录和FDA接收单位(举例来说，特定的中心，办公室，部门、分支机构)时的电子形式提交物是可接受的。
如果没有在公共摘要上明确出来，他们以电子形式提交给FDA接收单位的文件将不被认为是正式的；这种文件的书面形式将被认为是正式的但必须伴有电子记录。
美国FDA 21 CFR Part 11
法规解析：什么是FDA 21 CFR Part 11？美国FDA于1997年颁布21 CFRPart 11，并于2003年颁布相关行业指南来细化有关规则。
在Part11规定中，电子记录被认为具有与书面记录和手写签名同等的效力。
21CFRPart 11被美国的生物医药企业、医院、研究所和实验室广泛接受和遵照执行。
自颁布以来已被推广至全球，虽然没有强制性，但被欧洲、亚洲等地图和国家普遍接受和使用。
美国作为全球生物医药产业最主要组成部分影响力巨大，当你的药物、生物医药相关设备或者信息系统需要销售给美国的制药企业和研究人员都应该符合21 CFR Part 11的规定。
如违反，FDA能够根据规定剥夺出口到美国的权利。
其他国家对电子记录和电子签名也有类似要求，会以21 CFRPart 11的相关规定为指导原则，来制定本国的相关法规。
我国目前暂无像21CFR Part 11这样在生物医药领域针对电子记录和电子签名的规范或标准。
我国在2005年开始实施了《中华人民共和国电子签名法》，但这主要针对容易引起法律纠纷如合同、协议等的电子签名有效性的规定。
当前在GCP领域对中国来说，困扰的问题不仅在于你选择应用的信息系统是否适用于21CFR规定及是否验证，还在于如何建立一套较完善的实施GCP电子记录管理体系和电子签名有效性管理规范何时落地。
一、21 CFRPart 11涉及领域广泛(共有1499个部分) 21CFR=Food and Drugs 21CFR58=GLP 21CFR210=GMP, Drugs (General) 21CFR211=GMP, Drugs (Finished Pharmaceuticals) 21CFR312=Inv. New drug Application (GCP) 21CFR314=FDA Approval of new drug (GCP) 21CFR6xx=GMP, biologics 21CFR820=GMP, Devices 21CFR…= Food, nutrients and cosmetics 21CFR11=Electronic Records; Electronic Signatures 其中在GCP领域主要包括中心实验室建设、数据获取和报告、远程数据录入、CRF体系、临床数据管理、AE报告、临床支持体系和统计分析体系。
21CFR Part11-中英对照 Self整理
[联邦法规][第21章第1卷][2006年04月01日修改] [代号：21CFR 11]第21章－食品与药品第1节－食品和药品管理局健康与人类服务部亚节－一般规定[Code of Federal Regulations][Title 21, Volume 1][Revised as of April 1, 2006][CITE: 21CFR 11]TITLE 21--Food And DrugsCHAPTER I--Food And Drug Administration Department of Health And Human Services Subchapter A--General第11款电子记录；电子签名PART 11 Electronic Records; ElectronicSignatures分章A 一般规定11.1适用范围Subpart A--General Provisions Sec. 11.1 Scope.(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.However, this part does not apply to paper records that are, or have been, transmitted by electronic means.(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s)effective on or after August 20, 1997.(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
21CFRPart11介绍
➢ 21 CFR Part 11概述 ➢ 21 CFR Part 11内容解读 ➢ 21 CFR Part 11应用
➢ 21 CFR Part 11概述 ➢ 21 CFR Part 11内容解读 ➢ 21 CFR Part 11应用
什么是21 CFR Part 11
美国法规
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、 和随附的文件应便于被FDA用到，和服从于FDA的监管。
§11.2 执行
(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们 可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签 名。
(b) 提交给FDA的电子记录，人们可以使用全部或部分电子记录代替 纸制记录或电子签名代替传统签名（手签名）假如：
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求， FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的 FDA规则所求的一般签名。除非被从2019年8月20日起（包括该 日）生效后的规则明确地排除在外。
(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条 款要求的电子记录可以代替纸制记录使用。
§11.10 封闭系统的管理
(j) 为了阻止记录和签名的伪造，确立与坚持源自个人电子签名行为 的责任与职责的书面策略。 是否存在书面规定以使电子签名人，能够对其行为完全承担责任？
(k) 在系统文件方面运用适当的控制包括： （1）在分发的，有权使用，系统运转和维护方面使用的文件有足
够的控制。 （2）修订和改变控制程序以保持一个以时间顺序产生和修改的系
§11.50 签名的显示
(a)签署电子记录应包含能清晰显示如下所有与签名相关的信息： （1） 用印刷体书写出签名者的名字 （2） 签名生效的日期和时间；和 （3） 和签名相关的含意（例如回顾、批准、职责、或原创作者）
21-CFR-Part-11介绍
交给FDA接收单位的文件将不被认为是正式的；这种文件的书面形式
将被认为是正式的但必须伴有电子记录。人们期望与未来的FDA接收
单位就详细的（举例来说，传送的方法、媒体、文件格式和技术协议）
怎样和是否进行电子的提交物进行协商。
§11.3 定义
(a) 包含于法案201部分中术语的定义和翻译同样适用于那些在本条 款中使用到的术语。
21CFR11 = Electronic Records; Electronic Signatures
为什么遵循21 CFR Part 11
FDA要求和应用 全球范围内的广泛推广 国内暂无相关法规或标准
《中华人民共和国电子签名法》2005年4月1日起施行
符合质量管理的要求
应用
-GXP Training -GXP Tracking -SOP Systems
作中的电子记录 电子签名和电子记录的准则：可信的和可
靠的 电子签名 = 手写签名 最低要求 / 防止假冒
21 CFR
21CFR
= Food and Drugs
21CFR58 = GLP
21CFR210 = GMP, Drugs (General)
21CFR211 = GMP, Drugs (Finished Pharmaceuticals)
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、 和随附的文件应便于被FDA用到，和服从于FDA的监管。
§11.2 执行
(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们 可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签 名。
(b) 提交给FDA的电子记录，人们可以使用全部或部分电子记录代替 纸制记录或电子签名代替传统签名（手签名）假如：
21CFR第11部分在分析实验室中的实施(序言)第1部分总论与要求(待续)
统， 并且需要更高的安全等级。因此为了符合数字 签名的要求， 必须使用密码学的方法， 来对用户进行 鉴别和保证记录的完整性。 ２５ 生物测定学 ． 是指“ 基于一个人的物理特征， 或者是一个人可 测量可重复进行的特有行为， 来进行身份核实的一 种方法。例如面部和声音特征， ” 指纹扫描。大部分 的生物测定学方法都需要特殊的硬件和软件。这种 装置最大的问 题是确认它们可以 针对某个人可靠的 工作。 ２６ 混合系统 ． 结合电子和书面记录。这在当前的分析实验室 中很普遍。原始数据以电子数据的方式储存 ， 但最 后的结果以书面打印并手工签名。Ｆ Ａ不禁止使用 Ｄ 混合系统， 但对它们的有效性表示担心。
讲
座
２ 定义
确切理解新规定中的术语， 对于了解新规定的内 容以及新规定的执行非． 重要。因此我将使用与分 常
析实验室有关的 特定例子， 来详细阐明一些内 容。所 有的引用均来自 １ 第 １部分。 于２ＣＲ １ Ｆ
２１ 电子记录 ． 是指以数码方式， 由计算机系统创建 、 修改、 维 护、 归档、 追溯和颁布的所有结合文本、 图片、 数据、 声 音、 画报等的信息。 有关分析实验室的案例包括仪器 控制方法、 数据验证、 校正、 计算机原始数据的采集、 处理数据、 分析报告、 带基线的色谱图、 志和审计追 日 踪。如果这些信息已数码形式保存在永久存储设备
４ ４
万方数据
ａ ｏ＂Ｏ Ｈ ｇ ＇ Ｍ
去检查时， 企业莫名其妙的接到警告书。 仪器设备厂家认识到他们有责任更新硬件和软 件， 来帮助企业符合 ２ＣＲ第 １ 部分的相关规定。 １ Ｆ １ 有关更新文件， 新的刊物， 会议和指导原则的内容可 以在如下网站获得： ｗ ｗ ｌ ｃ ｐａｃ． ｅ ｓｎｔ ｓ ｍ ｌｎｅｃ ／ 一 ｉ ａ ｒ ｗ ． ｏ ｉ ａ ｂ ｏ ｍ ｇ ｕ ｅ
符合fda 21 cfr part 11 条款
符合FDS 21 CFR Part 11条款的意义一、 21 CFR Part 11的背景和重要性1. 21 CFR Part 11是美国食品和药物管理局(FDA)于2002年制定的一项规定，旨在规范药品、医疗器械等医疗健康产品的生产和使用过程中的电子记录和电子签名。
2. 该条款的实施对于确保医疗健康产品的质量、安全和可靠性具有重要意义，也是践行GMP、GCP、GLP等质量管理体系的重要保障。
二、 21 CFR Part 11的主要内容和要求1. 电子记录的要求a. 电子记录的格式应当具备可读性、可追溯性、一致性等特点，可以保证记录信息的真实、完整、可靠。
b. 电子记录应当具备变更追踪和审计功能，确保电子记录的修改和变更可以被追溯和审核，并且具备合适的权限控制功能。
2. 电子签名的要求a. 电子签名应当具备唯一性和不可伪造性，确保签名的真实性和完整性。
b. 电子签名应当具备合适的身份认证和权限控制功能，确保签名的授权和使用符合规定和流程。
三、符合21 CFR Part 11的意义和困难1. 符合21 CFR Part 11能够帮助医疗健康产品生产企业确保电子记录和电子签名的质量和可靠性，提高了数据的存储、管理和使用效率。
2. 符合21 CFR Part 11的过程中需要投入大量的人力、物力和财力，包括技术系统的升级和改造、人员的培训和管理制度的梳理等方面。
四、符合21 CFR Part 11的具体措施和实践1. 技术系统升级和改造a. 针对已有的电子记录和电子签名系统进行全面的评估，确定需要升级和改造的内容和方案。
b. 采用符合规定和标准的新技术系统，确保系统具备合适的记录、存储和管理功能，并且符合规定的安全和可靠性要求。
2. 人员的培训和管理a. 对于电子记录和电子签名的实施，需要对企业内部的相关人员进行培训，包括规定的政策、流程和标准等方面。
b. 完善内部管理制度，建立电子记录和电子签名的管理制度，明确相关人员的责任和权限。
联邦法规21章第11款 21 CFR Part 11
联邦法规21章第11款21CFR Part11联邦法规21章第11款21CFR Part11电子记录；电子签名分章A一般规定11.1适用范围11.2履行11.3定义分章B电子记录11.10封闭系统的控制11.30开放系统的控制11.50签名的验证11.70签名/记录连接分章C电子签名11.100一般要求11.200电子签名的构成及控制11.300识别代码和密码的控制分章A一般规定11.1适用范围(a)本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b)本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c)一旦电子签名和与它相关的电子记录符合本条款的要求，FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(d)依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
(e)在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA 用到，和服从于FDA的监管。
11.2履行(a)需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。
(b)提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1)符合条款的要求；和(2)提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。
21cfrpart11翻译
LabVantage 和21 CFR第11部分（了解规章和LabVantage如何成功地帮助客户支持其要求）内容提要:本文的目的是讨论21 CFR第11部分的要求和提供关于LabVantage Sapphire 是怎样支持这些规程的信息。
监管机构已经给出了关于展示数据的安全性和完整性的行业标准, 但没有遵循联邦规例（第11部分由美国食品和药物管理局）第21章第11部分。
此法规是1997年3月颁布，并已于1997年8月20日生效。
FDA能全面实施法律在制定规则方面，以至于确保电子记录和签名能像用纸记录或者手写签名那样值得信赖和可靠。
该规章适用于任何记录，电子或手写，或相关签名。
电子或手写，即提交给该机构（特别是21CFR第71，170，180，312，314，358514，515，571，601 ，860，861，1003，1010部分）。
下面讨论LabVantage Sapphire在具体处理第11部分符合规定的要求时的定位。
LabVantage致力于帮助客户实现这些规章。
SAPPHIRE遵循第11部分的关键功能：为了开始第11部分规定的讨论，有一些基本的信息关于LabVantage Sapphire的功能和有关部署和客户设置，这些是我们必须了解的。
>Sapphire可以部署一个“封闭系统”或“适当控制开放系统”。
>用户名/密码组合是Sapphire安全电子形式之一，当前Sapphire的记录与当前用户识别会被标记，他们满足一部分对电子签名的要求。
>用户名/密码组合只发给一个人。
>“打印名称”关系到第11部分包含在Sapphire用户的记录，它定义一个特定系统的用户。
>Sapphire用户的鉴定与电子签名是有联系的。
用户ID和时间/记录的邮戳日期部分，也是签名的一部分。
>LabVantage可以使用任何电子签名技术，例如，生物特征识别。
>一个“访问控制”时期是一个用户登录到Sapphire的时间。
21CFR-part11-中文版资料
21CFR-part11-中文版资料联邦法规21章第11款电子记录；电子签名分章A 一般规定11.1适用范围11.2 履行11.3 定义分章 B 电子记录11.10 封闭系统的控制11.30 开放系统的控制11.50 签名的验证11.70 签名/记录连接分章 C 电子签名11.100 一般要求11.200 电子签名的构成及控制11.300 识别代码和密码的控制分章A 一般规定11.1适用范围(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。
(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。
本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。
然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。
(c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA将会认为电子签名等同于完全手签名、缩写签名、和其他的FDA规则所求的一般签名。
除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。
(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。
(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA用到，和服从于FDA 的监管。
11.2履行(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。
(b) 提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1) 符合条款的要求；和(2) 提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。
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risk analysis according Gamp 5
- all parameters with indirect influence on the product quality.
CHRIST Using Siemens PCX77
Christ Christ Aqu@View Data Logger Integrate with PC477,577Touch PC
On the content of Part 11 will not be entertained here, since these guiding principles can easily be kept on application, and this would be in this extent too much and too profounding.
21 CFR Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records , and electronic signatures equivalent to traditional handwritten signatures
The Way Achieve “electronic records; Electronic signatures” Tradition recorder plus Audit-Trail SCADA Central Control System Christ Data logger plus Audit-or Control And Data Acquisition
21 CFR Part 11
What is 21 CFR Part 11
21 CFR Part 11 regulates the scales like process data how they have to be treated if they are archived electronical or will be documented. Thereby following have to be specially noted: Data security Data integrity Audit-Trail Password protection etc.
21 CFR Part 11
General overview about 21 CFR Part 11
valid version from 12.May.2010
Alex.Zhu Christ Pharma & Life Science (Shanghai) Ltd.
In august 1997, a new regulation from FDA was introduced, 21 CFR part 11 entitled “electronic records; Electronic signatures”
21 CFR Part 11
What falls under 21 CFR Part 11 -Parameter with immediate influence on the product :
-matters relating to quality (QR) Subpart D -safety relevant (SR) Predicate rules 21 CFR 211
Christ Aqu@View DataLogger
Christ Aqu@View DataLogger
Siemens Audit Trail
-- Tracking When? Who ? What?
21 CFR Part 11
Thank you for your attention