1. Purpose
The purpose of this Guideline is to provide requirements in the definition and documentation of raw data and also to outline recommendations on how to achieve compliance.
2. Scope and Applicability
This Guideline is applicable to any site, function and departments undertaking work, or providing support services, required to meet Good Manufacturing Practice (GMP)and/or International Organization for Standardization (ISO) standards.
3. Definitions
3.1 Raw Data
Raw data are defined as any work sheets, records, memoranda, or notes that are the result of original observations, findings, measurements or activities. This Guideline deals with those raw data that are necessary for the reconstruction, evaluation, and/or assurance of the integrity of a process, work project or report.
Raw data may be in the form of paper, computer readable media, magnetic media, photographs or film, microfilm or microfiche. Raw data may be created through handwritten notes, dictated observations, recorded data from instruments, data entered directly into a computer either manually or through an instrument interface or data printed automatically from devices.
3.2 Derived Data
Derived data are data that are produced or obtained from other data. Such data result when raw data elements are used in calculations, algorithms or other manipulations or evaluations to derive additional data.
4. Responsibilities
Functional Line Management are responsible for ensuring, with QA input where appropriate, that procedures for managing raw data are defined and that the raw data are securely retained and can be retrieved throughout their retention period.
5. Procedure
5.1 General Standards
Raw data must be recorded immediately, accurately and, excluding those data directly entered into a computer, legibly in indelible ink or equivalent onto adorable medium.
Raw data must be signed or initialled and dated by the individual responsible for recording those data. For computerized systems, the individual responsible for direct data input shall be identified at the time of data input.
Written standard procedures must be established for correcting, adding to, changing or deleting raw data. Any change in either paper based or computerized system raw data entries must be made so as not to obscure the original entry, must indicate the reason for the change, and must be dated and signed or initialled at the time of the change. Within a computerized system, the person responsible for these changes must be identified.
Correction fluid must never be used to correct (change or hide/delete) data. For observations initially recorded on one durable media, and subsequently transcribed into another, the original records are he raw data.
In some specific instances, exact/verified copies can replace the original raw data. For example, when data is stored electronically, when the recording medium is fragile (e.g., thermal paper or TLC plates) or when not accessible (e.g., documents produced in a highly controlled environment which may be hazardous if removed).
In these cases, a verified transcription or copy may be substituted for the original raw data provided the original is retained, and the copy includes the dated signature of the person who made it. It is strongly recommended that a statements included on the copy that it is a complete and accurate copy of the original.
Alternatively, procedures should state that the person making the copy is responsible for reviewing the copy and ensuring that it is complete and accurate.
Where data is created electronically and stored or archived, there may be practical issues with maintenance of the original format. In such cases, the transfer process for raw data from one format to a different format must be validated.
Recording systems, such as a tape recording or photographs, may be used as a means of collecting raw data. For recordings that are considered raw data, the time and date must either form part of the record or be written on a label affixed to the recording. The dated signature of the person making the record must also be added to the label.
Derived data should be appropriately controlled relative to the use and function of such data. In many cases, derived data are reportable values fully subject to predicate rules or other regulatory requirements. The controls described in this Guideline provide a useful framework for derived data.
5.2 Additional Standards for Electronic Raw Data
For observations entered directly into a computer system, either manually or via instrument interface, the computer record is considered the raw data. Any system which stores raw data electronically must be validated and comply with appropriate electronic records/electronic signatures requirements.
For equipment where the raw data is not stored as an electronic record, the original printout from that equipment, such as a chart from a temperature monitor, is considered the raw data.