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FDA 21 CFR Part 11 Compliance Assessment - PDF
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1 FDA 21 CFR Part 11 Compliance Assessment Prepared by Cohasset Associates, Inc. Abstract This technical report is an assessment of the EMC Data Domain Retention Lock Compliance edition capabilities relative to selected requirement areas of the Food and Drug Administration 21 CFR Part 11, Electronic Records; Electronic Signatures that can be met or supported by advanced electronic storage systems. Cohasset s conclusion is that the DD Retention Lock Compliance edition, when installed, configured, and enabled on the EMC Data Domain system, supports meeting 21 CFR Part 11 requirements and guidance in the areas of: a) authenticity and integrity and b) retention and disposition of electronic records. Cohasset Associates The capabilities of EMC Data Domain Retention Lock Compliance edition that support meeting these requirements include: a) establishing a records storage environment that uses integrated control codes, for records storage and handling, to preserve the authenticity and integrity of electronically stored records for the required retention period, b) setting a read-only status for and assigning a retention period to each record, c) assigning a unique identifier and date/time stamp that identifies the records and makes them accessible, and d) creating a duplicate or backup copy of all records with the associated retention period and protection controls for the purpose of disaster recovery Washington Ave. South Suite 500 Minneapolis, MN May 2013 Guiding the Way to Successful Records & Information Management
2 Table of Contents 1. Introduction CFR Part EMC Data Domain Retention Lock Compliance Edition Overview Assessment and Technical Report CFR Part 11 Compliance Assessment Storage-Related Part 11 Requirements Authenticity and Integrity Retention and Disposition Conclusions Matrix of DD Retention Lock Compliance Edition Capabilities Authoritative and Authentic Records Retention Management Accuracy and Quality of Stored Records Administrative Security Backup and Recovery...17 End Notes...18 About Cohasset Associates, Inc Table of Contents 2
3 1. Introduction This section establishes the context for this technical assessment. It provides an introduction to 21 CFR Part 11 and sets the foundation for identifying certain areas of requirements for electronic record systems that can be met or supported by advanced electronic storage systems. It then provides an overview of the storage system that is the subject of Cohasset s assessment CFR Part 11 The Food and Drug Administration ( FDA or Agency ) issued the final 21 CFR. Part 11 ( Part 11 or Rule ) in March of Part 11 provides the FDA criteria for accepting, under certain circumstances, electronic records, electronic signatures, and handwritten signatures executed on electronic records as the equivalent of paper records and handwritten signatures executed on paper. This rule makes electronic records and signatures as valid as paper records and handwritten signatures, thereby allowing the use of electronic recordkeeping systems for compliance. The scope of Part 11 is stated in 21 CFR 11.1: (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, Introduction 3
4 (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required. Between 1997 and early 2003, the FDA published a number of draft guidance documents to aid regulated entities in the implementation of Part 11. In the first half of 2003, the FDA withdrew many of these guidance documents. This withdrawal of the guidance documents resulted from the issues and challenges that were raised by regulated entities regarding the implementation of certain requirements and the challenges and burden of complying with Part 11. In August 2003, the FDA issued a guidance update document entitled Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application ( 2003 guidance document ). The 2003 guidance document was designed to describe and clarify the then current position of the FDA and make non-binding recommendations regarding the scope and application of Part 11. While the Part 11 regulation remains in effect, the FDA stated in the 2003 guidance document that the FDA will exercise enforcement discretion on many Part 11 requirements. The FDA is in the process of drafting an update to Part 11, which was initially scheduled to be released in The drafting, industry review and comments, and finalization of an updated Part 11 regulation are ongoing, and the date for its publication remains flexible. Part 11 is intended to permit the widest possible use of electronic technology, as long as it is compatible with the FDA s responsibility to protect public health. While Part 11 does not state that a specific type of electronic media or storage system is necessary to meet the requirements, the FDA provides some clarity regarding the use of electronic record technology in the Federal Register notice for the final Rule (Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997). Specifically, Section III, Comments on the Proposed Rule, Subsection C, Flexibility and Specificity, includes the following: The agency believes that the provisions of the final rule afford firms considerable flexibility while providing a baseline level of confidence that records maintained in accordance with the rule will be of high integrity. ***** The final rule accepts a wide variety of electronic record technologies, including those based on optical storage devices. Since Part 11 was issued in 1997, the advancements in storage technology coupled with the evolving records management requirements of federally-regulated entities have encouraged Federal agencies to accept storage technologies other than optical storage devices that provide similar levels of authenticity and integrity protection. Introduction 4
5 With regard to record retention, the FDA s 2003 guidance document specifies: The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period ( (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., (c),(d), (g), and (h)). A predicate rule is any requirement, including retention periods for records, set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. In this context, advanced digital storage systems can support meeting two requirement areas of the Rule: Authenticity and Integrity preserving the authenticity and integrity of electronic records required to be maintained as set forth in Agency regulations. Record Retention ensuring that electronic records maintained under the Rule are retained for the required retention period as stated in Agency regulations. The focus of this assessment report is on these two requirement areas. 1.2 EMC Data Domain Retention Lock Compliance Edition Overview EMC offers a software product named EMC Data Domain Retention Lock that can be applied to any MTree (a logical volume in a virtual file system) on a Data Domain system. When an MTree is configured to support DD Retention Lock software, a retention period can be set for individual record files that prevent them from being deleted before the retention period has expired. The DD Retention Lock software capability can be configured for either of two retention management environments: Compliance environment designed to meet a more strict set of records management requirements, such as those in Part 11, and Governance environment where the actions allowed by the client application or certain administrative storage functions may not meet certain requirements of Part 11. This assessment report focuses only on the DD Retention Lock Compliance edition. 1.3 Assessment and Technical Report To obtain an independent and objective assessment of the EMC Data Domain Retention Lock Compliance edition ( DD Retention Lock Compliance ) capabilities relative to meeting the pertinent requirement areas of Part 11, EMC ( EMC ) engaged Cohasset Associates, Inc. ( Cohasset ). Introduction 5
6 Cohasset ( is a highly respected records management consulting firm with recognized expertise and more than 40 years of experience serving companies that are guided by Part 11 regarding records management practices. Additional information about Cohasset Associates is provided at the end of this report. Cohasset s assignment was to: Assess the ability of DD Retention Lock Compliance to meet the pertinent requirements of Part 11, and Prepare this technical report regarding that assessment. This assessment represents the professional opinion of Cohasset Associates and should not be construed as an endorsement or rejection by Cohasset of the DD Retention Lock Compliance edition and its capabilities or other EMC products. To conduct this assessment, Cohasset relied upon four types of information provided by EMC regarding DD Retention Lock Compliance: a) oral discussions, b) system requirements documents, c) user guides, and d) other directly related materials. This assessment addresses only those requirements of Part 11 that could be met or supported by digital storage systems. Regulated entities must ensure that a combination of procedures, controls and application capabilities (operating in conjunction with the storage management capabilities addressed in this assessment) are employed to meet all requirements of Part 11 for electronic records. The content and conclusions of this assessment are not intended and should not be construed as legal advice. Relevant laws and regulations are constantly evolving, and legal advice must be tailored to the specific circumstances of the laws and regulations for each organization. Therefore, nothing stated herein should be substituted for the advice of competent legal counsel. Introduction 6
7 2. 21 CFR Part 11 Compliance Assessment This section presents Cohasset s assessment of DD Retention Lock Compliance capabilities that support meeting the relevant electronic records management requirements of Part Storage-Related Part 11 Requirements Two requirement areas of Part 11 are assessed in this report to determine the degree to which they can be met or supported by the capabilities of DD Retention Lock Compliance: 1. Authenticity and Integrity managing records so as to make them authentic and to preserve their integrity against unauthorized alteration or deletion, and 2. Retention and Disposition retaining records for as long as required by predicate FDA regulations. Each assessment of the two requirement areas are structured into three sections: Compliance Requirements related to a specific Part 11 requirement area, DD Retention Lock Compliance Capabilities that meet or support meeting the compliance requirements, and Compliance Assessment which summarizes Cohasset Associates assessment regarding the degree to which DD Retention Lock Compliance capabilities support meeting the compliance requirements. 2.2 Authenticity and Integrity Compliance Requirements Under Part 11, Subpart B Electronic Records, section Controls for closed systems, the requirement for authenticity and integrity of records is described as: Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily Compliance Assessment 7
8 repudiate the signed record as not genuine. Such procedures and controls shall include the following: authentic record as defined in Part 11 is described as having the characteristics of: ***** (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. (d) Limiting system access to authorized individuals. ***** The authenticity and integrity requirements also apply to open systems as stated in Subsection Controls for open systems: Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt DD Retention Lock Compliance Capabilities DD Retention Lock Compliance has multiple capabilities that support meeting the Part 11 requirement that records must be authentic, including preserving record integrity during storage and retrieval. A non-erasable, non-rewriteable record management environment is established by configuring an MTree with DD Retention Lock Compliance software. At the time each record is stored the following actions occur: Each record is set to a read-only status and a retention period is assigned, A unique identifier, including a date/time of recording, is assigned to the record, and Each record is validated during the recording process to verify its quality and accuracy. At the time each record is retrieved and periodically during the retention period, it is checked for errors and error correction capabilities are employed to correct errors, as required. Any attempt to erase, overwrite or alter a record file or the complete record file system during the assigned retention period whether by a client application, a local user, or a system administrator will be rejected and will result in an error condition in the system. Compliance Assessment 8
9 If a DD Retention Lock Compliance license expires or is deleted from the Data Domain system, the integrity of record files currently stored will continue to be protected for the established retention period. DD Retention Lock Compliance provides for setting up a second Compliance MTree, locally or remotely, where a duplicate copy of all records (with their associated retention and protection codes) can be stored and used for recovery should the primary copy of records be compromised or destroyed. More detailed descriptions of these capabilities and their support for ensuring that stored records are authoritative are provided in Section 4 of this report Compliance Assessment It is the opinion of Cohasset Associates that DD Retention Lock Compliance, when deployed on the Data Domain system, provides strong capabilities for meeting 21 CFR Part 11 requirements that records be authentic and that the integrity of the records is protected for the required retention period. 2.3 Retention and Disposition Compliance Requirements The requirements for retention of records will generally be established by the regulation that requires the record, such as retention requirements cited in or related to the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any other FDA regulation. In Section III, Comments on the Proposed Rule, in the paragraphs related to Scope ( 11.1), the FDA clarified that the term maintain includes the ability to retain records for the specified period of time.... the agency intends for the term maintain to include records retention. Under Part 11, Subpart B Electronic Records, Section 11.10, Controls for closed systems, the requirement for the retention of records is addressed in conjunction with protecting record authenticity and integrity: ***** (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. Compliance Assessment 9
10 There are two basic types of record retention time-based 1 and event-based (a.k.a. event/timebased). There are a limited number of record types described in Agency predicate rules that have time-based retention periods meaning that they are to be retained for a fixed period of time after the date of recording to an electronic media or system. Most records required to be retained under predicate rules are event-based records. It is Cohasset Associates experience, however, that in certain record retention situations, regulated entities often convert some of the event-based retention requirements to time-based periods to ease implementation. For example, the following regulation stipulates an event-based retention period of 1 year after the expiration date of the batch or... 3 years after distribution of the batch CFR General requirements. (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under , 3 years after distribution of the batch. ***** It is Cohasset Associates experience that a regulated entity may determine the longest time period for the event, based on their internal operations, and then calculate a time-based retention period. For example, for production records with a batch expiration day of 5 years, the organization may convert the event-based retention period of 1 year after the expiration date of the batch to a timebase period of 6 years DD Retention Lock Compliance Capabilities DD Retention Lock Compliance has multiple capabilities that support the retention and disposition of electronic records. The capabilities that can meet this requirement are summarized below. A non-erasable, non-rewriteable record management environment is established by configuring an MTree with DD Retention Lock Compliance software. Within a Compliance MTree, a retention period can be set and a read-only status can be activated for each record file thereby establishing the time period during which specific records would be protected against erasure, overwrite, or alteration. Any attempt to delete a record file or the complete file system prior to the expiration of the assigned retention period whether by a client application, a local user, or a file system administrator will be rejected and will result in an error condition. Compliance Assessment 10
11 Minimum and Maximum retention period attributes can be set to ensure that no retention period is set that is lower than the Minimum attribute value nor higher than the Maximum attribute value. The retention period for individual record files can be extended, but not lowered. This addresses the need for potentially longer retentions that may result from litigation or investigative holds. If the DD Retention Lock Compliance edition is either uninstalled or expired from the Data Domain system, all record files currently stored will continue to be protected for their designated retention periods. Once the retention period for a record has expired, DD Retention Lock Compliance allows the client application to delete the record. The record cannot be deleted via the system administration interface, even using dual sign-on. Detailed descriptions of these capabilities and their support for retention and disposition of records are provided in Section 4 of this report Compliance Assessment It is Cohasset Associates opinion that DD Retention Lock Compliance provides capabilities that support meeting the record retention requirements of Part 11. Compliance Assessment 11
12 3. Conclusions Cohasset s conclusion is that the DD Retention Lock Compliance edition configured on a Data Domain system supports meeting requirements in the two requirements areas of Part 11 described in Section 2, above. The capabilities of DD Retention Lock Compliance that support meeting these requirements are: A records management environment can be established that uses integrated control codes to ensure that the stored records are authentic that their integrity will be preserved during the required period of retention, Once the retention period and read-only status are established in the system, a record cannot be deleted until the retention period has expired thereby protecting stored records from erasure, overwrite, or alteration during the retention period, The assignment of a unique identifier and date/time stamp that identifies the records and makes them accessible, and When a duplicate or backup copy of the records (with the associated retention periods and protection) is created, it can be used to recover records in the event of a disaster. Conclusions 12
13 4. Matrix of DD Retention Lock Compliance Edition Capabilities The following table provides greater detail of DD Retention Lock Compliance capabilities that enable it to meet or support meeting the two areas of the Part 11 requirements described in Section 2, above. The column labeled Authenticity & Integrity denotes (with an ) those capabilities of DD Retention Lock Compliance on a Data Domain system that support meeting the requirements for keeping records that are authentic where reliability and integrity is ensured and the records are protected against malicious (or inadvertent) destruction or alteration. The column heading Record Retention denotes (with an ) those capabilities of DD Retention Lock Compliance on a Data Domain system that support setting a retention period and allowing extensions, but not reductions, of the retention period. Matrix 13
14 4.1 Authoritative and Authentic Records Authenticity & Integrity Record Retention In order to activate the record retention and protection capabilities of DD Retention Lock Compliance, an organization must acquire and implement a unique DD Retention Lock Compliance edition license that ensures that the compliance features of Retention Lock are activated. During administrative setup of DD Retention Lock Compliance, one or more Compliance MTrees can be defined, thereby allowing compliance capabilities to be applied to record files. After an MTree has been configured with DD Retention Lock Compliance, that MTree cannot be disabled or overridden. A Minimum and Maximum time-based retention period for each MTree must be established during the administrative setup of DD Retention Lock Compliance on a Data Domain system. This ensures that the atime 2 retention expiration date for a record is not set below the Minimum or above the Maximum. Once set, the Minimum and Maximum retention periods cannot be reduced; they can only be extended. For a Managed Tree (MTree) that is DD Retention Lock Compliance enabled, a new record file can be placed under Compliance control and a time-based retention expiration date (retention period) set. The retention period is set when the client application: a) issues a file protocol instruction with an atime retention attribute that is set into the future (beyond the date/time of recording) and b) where the retention expiration date is greater than the Minimum defined retention period per MTree and less than the Maximum defined retention period per MTree. The retention period is then managed as follows: Any atime value that is less than or equal to current time and therefore not a valid retention period is ignored since it is assumed to be an update to the time last accessed value. If the atime retention expiration date supplied by the client application less than the Minimum retention period or greater than the Maximum retention period, then an error condition will be returned to the client application. If an attempt is made to delete a record file where the retention period has not expired, then the delete command results in an error condition. If an attempt is made to delete an MTree, that is DD Retention Lock Compliance enabled, which contains record files, then the delete command results in an error condition. 4.2 Retention Management Authenticity & Integrity Record Retention A retention period is set when an atime retention expiration date (the retention period) is set by the client or user application sending the record to DD Retention Lock Compliance. Once the retention period has been set for an individual record file, it cannot be deleted or overwritten until the retention period expires. Once the retention period has expired, deletion of the record file may be performed by an authorized client application or system administrator. Matrix 14
15 An existing retention expiration date cannot be reduced. DD Retention Lock Compliance will return an error condition to the client application when the new atime retention expiration date is received that is earlier in time than the current atime retention expiration date. The retention expiration date for a record file under DD Retention Lock Compliance control may be extended by recording a new atime retention attribute for the record file that is later in time than the current retention expiration date and less than the Maximum retention. 4.3 Accuracy and Quality of Stored Records Authenticity & Integrity Record Retention The objective of these capabilities is to provide the utmost confidence that all records read from the storage media are precisely the same as those recorded. Initial Recording Process DD Retention Lock Compliance provides an exceptionally strong capability for verifying quality and accuracy for each container of record file data that is written. An inline read verification at the time of recording is performed before being accepted as error-free. This method goes beyond the minimum acceptable reliance on state-of-the-art magnetic disk recording error checking and detection/correction capabilities. Post Recording Process Record file data is packaged and written in containers (multi-megabyte units). A strong checksum value is calculated from the data in each container and stored with that container. The write verification process involves reading back the data in the stored containers and verifying that the checksums are accurate. After the containers are verified, the files contained in them are verified by reading the metadata of the files and verifying that each segment of a file exists in the container identified by the metadata. During verification, if the checksum does not match for any container, RAID 6 3 is used to correct the errors and recover the container. If the container cannot be recovered using RAID 6, an alert is raised to the client application whereupon the administrative support personnel can recover the data from a replicated or duplicate copy. During read-back of a record file, whether by the client archiving application or by the Data Domain file system, the checksums are verified and, when errors are encountered, RAID 6 error correction is applied as required, thereby ensuring that the record remains complete and accurate. Periodic scrubbing of the record file data on the Compliance enabled MTree is performed to find and correct any defects that may occur. This is particularly important for those record files that have not been read back for an extended period of time. Matrix 15
16 4.4 Administrative Security Authenticity & Integrity Record Retention A Compliance MTree cannot be deleted under any circumstances, not even with dual sign-on authorization. When a DD Retention Lock Compliance license has expired or is cancelled for any reason, no new Compliance MTrees can be defined. However, all of the record files in all existing Compliance MTrees will continue to be protected. Also any new files that are stored in existing Compliance MTrees, with a retention period atime later than the day stored, will continue to be protected. Additional administrative security is provided via DD Retention Lock Compliance to ensure that certain administrative functions or actions that could potentially compromise the integrity of record files prior to expiration of the retention period are not under the control of just one administrative person. This additional administrative security is provided in the form of a dual sign-on, i.e., sign-on by the regular system administrator plus the requirement for second sign-on by an authorized person. The primary administrative actions that require a dual sign-on in a DD Retention Lock Compliance enabled Data Domain system are: Extending Minimum or Maximum retention periods. Renaming an MTree. Deleting a DD Retention Lock Compliance license. Other system support or maintenance actions that could potentially compromise the integrity of stored record files where the retention period has not expired. No logical access (via a software user interface) without dual sign-on security is allowed for error correction purposes, such as the scenario where the Data Domain system experiences a system error or corruption. For the extreme scenario where the full Data Domain operating system will not start up, the only means to start or restart the system is through single user access to the system via a physical USB drive which must be protected and available only with dual sign-on authorization. The accuracy of the system clock in DD Retention Lock Compliance is critical for determining whether the retention expiration date of a record file has expired. Situations can occur, such as a power outage, maintenance downtime, etc., which may affect the accuracy of the system clock and require it to be adjusted or reset. Additional statistics are gathered, analyses are performed and certain restrictions are placed on ensuring the accuracy of the system clock to meet retention compliance requirements. The accuracy of the system clock and variations of the system clock with current actual time is regularly monitored. The system clock is only allowed to vary by a maximum of two weeks in a year. Should the system clock vary beyond the two-week maximum during a year, then the administrative dual sign-on is required to reset the clock to current time. Matrix 16
17 4.5 Backup and Recovery Authenticity & Integrity Record Retention The intent of this capability is to provide an alternate storage source for maintaining retention and protection and for accessing the electronic record should the primary source be compromised, i.e., lost or damaged. The DD Retention Lock Compliance provides for an MTree to be replicated to a second Data Domain system configured with DD Retention Lock Compliance, either locally or remotely. During replication, all record files and associated metadata, including retention metadata, are replicated to the file system or MTree on the destination DD Retention Lock Compliance enabled Data Domain system. Should a major error occur that makes the original file system or MTree inaccessible, then the record files can be recovered from the replicated copy of the MTree. Matrix 17
18 End Notes 1. DD Retention Lock Compliance currently supports time-based retention (i.e., retain for a specified period from the time after the file is recorded). Event-based retention (i.e., indefinite retention once the file is recorded until a specified event occurs, followed by a fixed, final retention period) is not currently supported. 2. The atime attribute in standard file protocol instructions represents the time last accessed for a file. For Retention Lock Compliance enabled MTrees, this attribute is utilized to establish the retention expiration date for a record file. 3. Redundant Array of Independent Disks (RAID): A method for recording data to magnetic disk devices, which provides for various levels of error correction and read or write performance improvements. RAID 6 employs striped disks with dual parity and combines four or more disks in a way that provides for correction of detected errors for up to as many as two full disk units of data during read-back. End Notes 18