by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails,
photographs, microfilm or microfiche, audio- or video-files or any other media whereby information related to GxP activities is recorded.
data governance. The sum total of arrangements to ensure that data, irrespective of the format in which it is generated, are recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle. data integrity. Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. data lifecycle. A planned approach to assessing and managing risks to data in a manner commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the process by which data is created, processed, reviewed, analyzed and reported, transferred, stored and retrieved, and continuously monitored until retired.
dynamic record format. Records in dynamic format, such as electronic records, that allows for an interactive relationship between the user and the record content. For example, electronic records in database formats allow the ability to track, trend and query data; chromatography records maintained as electronic records allow the user to
reprocess the data, view hidden fields with proper access permissions and expand the baseline to view the integration more clearly.
fully-electronic approach. The term “fully-electronic approach” refers to a computerized system use in which the original electronic records are electronically signed.
good documentation practices. In the context of these guidelines, good
documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.
GxP. Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing and post-market activities for regulated pharmaceuticals, biologics, medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices and good distribution practices.
hybrid approach. The term “hybrid approach” refers to the use of a computerized system in which there is a combination of original electronic records and paper records that comprise the total record set that should be reviewed and retained. For example, where laboratory analysts use computerized instrument systems that create original electronic records and then print a summary of the results. Persons execute a handwritten signature to electronic records, for example, by hand-signing a review checklist that is then securely linked to the electronic records being signed. The hybrid
approach requires a secure link between all record types throughout the records retention period.
quality risk management. A systematic process for the assessment, control,
communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle (ICH Q9).
metadata. Metadata are data about data that provide the contextual information required to understand those data. Typically, these are data that describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual. For example, in weighing the number 8 is meaningless without metadata, i.e. the unit, mg. Other examples of metadata may include the time/date stamp of the activity, the operator ID of the person who performed the activity, the instrument ID used, processing parameters, sequence files, audit trails and other data required to understand data and reconstruct activities. static record format. A static record format, such as a paper or pdf record, is one that is fixed and allows no or very limited interaction between the user and the record content. For example, once printed or converted to static pdfs, chromatography records lose the capabilities of being reprocessed or enabling more detailed viewing of baselines or any hidden fields.
senior management. Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (ICH Q10 based in part on ISO 9000:2005).
true copy. A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.
4. PRINCIPLES
Good data and record management are critical elements of the pharmaceutical quality system and a systematic approach should be implemented to provide a high level of assurance that across the product life cycle all GxP records and data are accurate, consistent, trustworthy and reliable.
The data governance programme should include policies and governance procedures that address the general principles listed below for a good data management program. These principles are clarified with additional detail in sections below.
Applicability to both paper and electronic data. The requirements for good data and record management that assure robust control of data validity apply equally to paper and electronic data. Organizations subject to GxP should be fully aware that reverting from automated/ computerized to manual/paper-based systems does not in itself remove the need for robust management controls.
Applicability to contract givers and contract acceptors. The principles of these guidelines apply to contract givers and contract acceptors. Contract givers are
ultimately responsible for the robustness of all decisions made on the basis of GxP data, including those that are made on the basis of data provided to them by contract
acceptors. Contract givers therefore should perform due diligence to assure themselves that contract acceptors have in place appropriate programmes to ensure the veracity, completeness and reliability of provided data.
Good documentation practices : To achieve robust decisions and data sets based need to be reliable and complete. Good documentation practices (GDP) should be followed in order to ensure all records, both paper and electronic, allow the full reconstruction of the related activities.
Management governance. To establish a robust and sustainable good data
management system it is important that senior management ensure that appropriate data management governance programmes are in place. Elements of effective management governance should include:
? application of modern quality risk management principles and good data management principles to the current quality management system to integrate those elements that assure the validity, completeness and reliability of data. For example, monitoring of risks and application of appropriate quality metrics can help management gain the awareness necessary for good decision-making to reduce data integrity risks;
? management should ensure personnel are not subject to commercial, political, financial and other organizational pressures or incentives that may adversely affect the quality and integrity of their work;