{"id":16652,"date":"2026-07-18T13:32:28","date_gmt":"2026-07-18T11:32:28","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/vorgaben-vs-records-begriff\/"},"modified":"2026-07-19T21:02:58","modified_gmt":"2026-07-19T19:02:58","slug":"instructions-vs-records","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/instructions-vs-records\/","title":{"rendered":"Instructions vs. Records"},"content":{"rendered":"<p>Two types of documents carry every GxP quality management system. Instructions (specifications, procedures, plans) are reviewed and approved before release &ndash; approved, signed and dated; signed alongside the instructions are the evaluating reports that carry the release decision. Records evidence execution as instructed &ndash; contemporaneous and truthful, with traceable changes; their standard is <a href=\"https:\/\/q-finity.de\/en\/glossar\/alcoa\/\" target=\"_self\" title=\"ALCOA is a common acronym summarizing the criteria of data integrity (the ALCOA principles). It stands for: Attributable (i.e., identification of the source, the data originator - person, device, or system) Legible (and understandable) Contemporaneous (i.e., recorded at the time) Original (the initial record itself - paper-based or electronic - or a certified\/true copy) Accurate&hellip;\" class=\"encyclopedia\">ALCOA<\/a>++. A signature per record is not required &ndash; attribution is provided by the controlled system: the signature follows the decision, not the record. Form is free, but not formless: EU GMP Chapter 4 explicitly allows documentation to be paper-based, electronic or photographic &ndash; but requires that the media used be fully defined in the QMS and that suitable controls ensure accuracy, integrity, availability and legibility. The device standard ISO 13485 calls records, in its normative text, &ldquo;a special type of document&rdquo; (4.2.4).<\/p>\n<p><em>See also: <a href=\"https:\/\/q-finity.de\/en\/glossar\/electronic-record\/\" target=\"_self\" title=\"Electronic record describes any combination of text, graphics, data, audio, images or other informational representations in digital format generated, modified, maintained, archived, accessed or distributed by a computer system (cf. 21 CFR Part 11).\" class=\"encyclopedia\">Electronic Record<\/a>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/audit-trail\/\" target=\"_self\" title=\"An audit trail is the secure, computer-generated, time-stamped record of relevant creations, changes, and deletions of GxP-relevant data - who, what, when, and why; which events it captures is defined on a risk basis (EU GMP Annex 11 &sect;9; 21 CFR 11.10(e)). It makes changes reconstructable (Traceable) and is a regular focus of inspections.\" class=\"encyclopedia\">Audit Trail<\/a>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-governance\/\" target=\"_self\" title=\"Data governance encompasses the organizational and technical structures that keep data available, with integrity - changeable under control and traceable - and ALCOA++-compliant across the entire data lifecycle. This includes roles and responsibilities, decision-making functions and committees, and controls - anchored in the QMS and in the technology.\" class=\"encyclopedia\">Data Governance<\/a>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services.\" class=\"encyclopedia\">Quality Management<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Two types of documents carry every GxP quality management system. Instructions (specifications, procedures, plans) are reviewed and approved before release &#8211; approved, signed and dated; signed alongside the instructions are the evaluating reports that carry the release decision. Records evidence execution as instructed &#8211; contemporaneous and truthful, with traceable changes; their standard is ALCOA++. A [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16652","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Instructions vs. Records in the GxP QMS | QFINITY<\/title>\n<meta name=\"description\" content=\"Instructions are approved before release, records evidence execution to ALCOA++ - the signature follows the decision, not the record. 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