Every compliance question answered on this site, grouped by how far the software goes. 164 question(s) on 102 page(s): Built 117, Partly built 25, Customer responsibility 7, Not built yet 15.
Each question on a page is marked with one of four statuses:
- Built — The software does this today; the evidence is cited.
- Partly built — The software does part of this; the limits are stated.
- Customer responsibility — The software cannot do this for you; your organization must.
- Not built yet — Asked for, or expected, but the software does not do it.
This is evidence of what the software does. It is not a certification, and the software is not described anywhere on this site as validated: validation of the system for your intended use is your organization's responsibility.
Not built yet (15)
Partly built (25)
Customer responsibility (7)
| Question | References | Page |
|---|---|---|
| Are there written policies that hold individuals accountable for what they do under their electronic signatures? | Part 11 11.10(j) | 21 CFR Part 11 |
| Will the records still be available, and readable, throughout the retention period? | ALCOA+ available, Annex 11 7, ICH E6 essential-records | ALCOA+ |
| Does the system support the record of processing activities? | GDPR art.30 | Data privacy: HIPAA, GDPR and DPDP |
| Is periodic review of the validated state supported? | Annex 11 11 | GAMP 5 and computer system validation |
| Is participant or personal data sent to the AI provider? | GDPR art.25, GDPR art.28, Annex 11 3 | AI form generation and the AI workstation |
| Who decides that an answer is acceptable, and how quickly must queries be handled? | ICH E6 quality-management, ICH E6 data-corrections | Work with queries |
| Does the AI processing keep data within an agreed region and out of model training? | GDPR art.28, GDPR art.32, GDPR art.25 | AI |
Built (117)
| Question | References | Page |
|---|---|---|
| Is a record legible, and is the copy an inspector receives readable without the system? | ALCOA+ legible, Part 11 11.10(b), Annex 11 8 | ALCOA+ |
| Can a reviewer check independently that the audit trail is intact? | Part 11 11.10(e), Annex 11 9, ICH E6 data-governance | Audit trail and evidence |
| Can the audit trail be altered or deleted by the application, or by someone using its credentials? | Part 11 11.10(e), Annex 11 9, ALCOA+ enduring, ALCOA+ original | Audit trail and evidence |
| Is the time of every event the system's own, so that a wrong clock cannot misdate a record? | ALCOA+ contemporaneous, Part 11 11.10(e), Annex 11 9 | Audit trail and evidence |
| Is the configuration of a study under change control, so that "what was in force on this date" can be answered? | Part 11 11.10(k), Annex 11 10, ICH E6 computerised-systems | GAMP 5 and computer system validation |
| Is access protected against unauthorized use at the network edge, with transport security and secure session handling? | Annex 11 12, Part 11 11.10(d), GDPR art.32 | Security and hosting |
| Are licensing decisions made by named platform administrators and recorded? | Annex 11 3, Annex 11 12, ALCOA+ attributable | Platform console: feature switches |
| Can the operator withdraw an organization's access immediately, and is the decision recorded with its reason? | Part 11 11.10(d), Annex 11 12, Annex 11 16, ALCOA+ attributable | Platform console: manage an organization |
| Is the creation of a tenant and its first administrator controlled and traceable? | Part 11 11.10(d), Part 11 11.10(e), Annex 11 12, ALCOA+ attributable | Platform console: provision an organization |
| Is access to the platform's administrative functions limited to named individuals, and are failed attempts recorded? | Part 11 11.10(d), Part 11 11.300, Annex 11 12, ALCOA+ attributable | Platform console: signing in and platform administrators |
| Is anything the AI produced accepted without a person reviewing it, and is its use recorded? | Part 11 11.10(a), Annex 11 4, ICH E6 computerised-systems | AI form generation and the AI workstation |
| Can a hidden field block a form from being completed, or hide data that was entered? | ALCOA+ complete, Part 11 11.10(f) | Conditional logic: showing, hiding and setting values |
| Can a default value end up in the record as if the person had entered it? | ALCOA+ attributable, ALCOA+ accurate, Part 11 11.10(e) | Field properties, tab by tab |
| Does the system keep what was entered exactly as it was entered, in a form that does not depend on how the field is displayed? | ALCOA+ original, ALCOA+ accurate, Part 11 11.10(c) | Field types |
| Can a calculated value be altered by someone, or be wrong because of the browser? | Part 11 11.10(a), Part 11 11.10(f), ALCOA+ accurate, ALCOA+ original | Formulas and calculations |
| Can the exact design that was tested and signed be produced, and matched to the data? | Part 11 11.10(b), Part 11 11.10(k), Annex 11 8, ALCOA+ available, ICH E6 computerised-systems | Importing and exporting a design |
| Can a standard form be reused across studies without the copy changing later? | Part 11 11.10(k), Annex 11 10 | The form library and templates |
| Is every change to a form's design recorded, with who and when, and can an earlier design be read back? | Part 11 11.10(e), Part 11 11.10(k), Annex 11 9, Annex 11 10, ALCOA+ original | The form builder: an overview |
| Is a form tested before it is used for real data? | Part 11 11.10(a), Annex 11 4, Annex 11 10, ICH E6 computerised-systems | Preview and testing a form |
| Are the values in a table cell checked and recorded as carefully as those in a field? | Part 11 11.10(e), Annex 11 6, ALCOA+ accurate, ALCOA+ original | Tables and repeating groups |
| Are out-of-range values flagged for review rather than silently accepted or refused? | ICH E6 data-corrections, ALCOA+ accurate, Part 11 11.10(f) | Units and normal ranges |
| Are values checked as they are entered, and is a check applied in the same way on every route into the system? | Part 11 11.10(f), Annex 11 6, ALCOA+ accurate | Validation, edit checks and their severities |
| Are changes to a released data-collection design controlled, tested and approved before they take effect? | Part 11 11.10(k), Part 11 11.10(a), Annex 11 10, ICH E6 computerised-systems | Versions, reopening and publishing |
| Can a field that holds data be removed from a form? | ALCOA+ enduring, ALCOA+ original, Part 11 11.10(c) | Versions, reopening and publishing |
| Is the schedule of assessments (which forms at which visits) controlled and part of what is tested and signed? | Part 11 11.10(k), Annex 11 10, ICH E6 protocol-compliance | Binding a form to visits |
| Is every operation behind an access check, or can a script do what a screen refuses? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 data-governance | API reference |
| Which events does the audit trail record? | Part 11 11.10(e), Annex 11 9, ALCOA+ attributable, ALCOA+ complete | Audit events |
| Are documents version-controlled, and can an earlier version be produced? | Part 11 11.10(k), Annex 11 10, ICH E6 essential-records, ALCOA+ original | Documents reference |
| Can I obtain a complete, accurate copy of the records for inspection? | Part 11 11.10(b), Annex 11 8, ALCOA+ complete, ALCOA+ available | Exports reference |
| Can a role be given both sides of a separation of duties, such as entering data and locking it? | Part 11 11.10(g), Annex 11 12 | Roles and permissions |
| Is access limited to authorized people, by role? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 data-governance | Roles and permissions |
| Can a study's own checks be changed after release without a record of it? | Part 11 11.10(a), Part 11 11.10(k), Annex 11 10 | Rules reference |
| Does a safety or eligibility rule that never fires look as if it is working? | Part 11 11.10(h), ALCOA+ accurate | Rules reference |
| Can the protocol-level settings of a study be changed after release without a record? | Part 11 11.10(k), Annex 11 10, ALCOA+ accurate | Settings |
| Is there a session timeout and a cap on how long a session lives? | Part 11 11.10(d), Part 11 11.300, Annex 11 12 | Settings |
| Does the system enforce the order of steps, or can a status be set to anything? | Part 11 11.10(f), Annex 11 12, ALCOA+ consistent | Statuses |
| Are the rules a configuration that could be weakened? | Part 11 11.10(f), Annex 11 12 | Who can and cannot: the rules in force |
| Can an administrator override a separation rule? | Part 11 11.10(g), ICH E6 data-governance | Who can and cannot: the rules in force |
| Can one person do everything on a study? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 data-governance | Who can and cannot: the rules in force |
| Can an auditor examine the records and the audit trail without being able to alter them? | Part 11 11.10(b), Part 11 11.10(e), Annex 11 9, ICH E6 data-governance, ALCOA+ available | Auditor |
| Is a query closed by someone independent of the person who raised or answered it? | Part 11 11.10(g), ICH E6 data-corrections, ALCOA+ accurate | Clinical Data Coordinator |
| Is source data verification independent of data entry, and is its evidence tied to the value verified? | ICH E6 monitoring, Part 11 11.10(e), ALCOA+ original, ALCOA+ attributable | Clinical Research Associate |
| Is each value attributed to the person who entered it, and can a saved value be changed only with a reason? | Part 11 11.10(e), Part 11 11.10(g), ICH E6 data-corrections, ALCOA+ attributable, ALCOA+ accurate | Clinical Research Coordinator |
| Is data review independent of data entry, and is the resolution of a discrepancy confirmed by someone other than the person who answered it? | Part 11 11.10(g), Part 11 11.10(e), ICH E6 data-corrections, ALCOA+ accurate | Data Manager |
| Is a validated design protected from change after it has been tested? | Part 11 11.10(a), Part 11 11.10(f), Annex 11 4, Annex 11 10 | eCRF Designer |
| Is the person who designs the data collection kept away from the data it collects? | Part 11 11.10(g), Annex 11 2, Annex 11 12, ICH E6 computerised-systems | eCRF Designer |
| Is there an independent medical review of serious events, kept apart from the site's report? | ICH E6 safety-reporting, Part 11 11.10(e), ALCOA+ attributable | Medical Officer |
| Is the administrator of the system independent of the people who enter and sign the clinical data? | Part 11 11.10(g), Annex 11 2, Annex 11 12, ICH E6 investigator-oversight | Organization Admin |
| Is a role limited to the data entry its task needs? | Part 11 11.10(g), Annex 11 12, ICH E6 delegation | Pharmacy |
| Does the site's staff have access only after the investigator has authorized them? | ICH E6 delegation, Part 11 11.10(d), Part 11 11.10(g) | Principal Investigator |
| Is the investigator's responsibility for eligibility, delegation and signature exercised only by the investigator? | ICH E6 investigator-oversight, ICH E6 delegation, Part 11 11.100, Part 11 11.200, Annex 11 14 | Principal Investigator |
| Can the person who runs the study alter the data it collects? | Part 11 11.10(g), Annex 11 12, ICH E6 investigator-oversight, ALCOA+ original | Project Manager |
| Is the release of a validated configuration approved by independent people, and by whom? | Part 11 11.10(a), Part 11 11.10(g), Annex 11 4, Annex 11 10, ICH E6 computerised-systems | Project Manager |
| Are regulatory documents version-controlled and approved, with a record of who handled them? | ICH E6 essential-records, Part 11 11.10(k), Annex 11 10 | Regulatory Manager |
| Can oversight of site conduct be exercised without the ability to change the site's data? | ICH E6 monitoring, Part 11 11.10(g), Annex 11 12 | Site Monitor |
| Does the sponsor approve a release independently of the people who built and tested it? | Part 11 11.10(g), Part 11 11.200, Annex 11 4, Annex 11 14, ICH E6 computerised-systems | Sponsor Manager |
| Is access for external supply staff limited to what their task needs? | Part 11 11.10(d), Annex 11 12, ICH E6 data-governance | Sponsor Supply Manager |
| Are sign-in credentials controlled, limited in attempts and not reusable? | Part 11 11.300, Part 11 11.10(d), Annex 11 12 | Signing in |
| Is a protocol change implemented under control, with participants consenting again where required? | Part 11 11.10(k), Annex 11 10, ICH E6 informed-consent, ICH E6 protocol-compliance | Amend a live study |
| Is a study's data-collection design built under change control from the start? | Part 11 11.10(k), Annex 11 10, ICH E6 computerised-systems | Build a study |
| Are the reasons a participant leaves the study recorded in a standard form, with the safety follow-up that remains owed? | ICH E6 protocol-compliance, ICH E6 safety-reporting, ALCOA+ complete, Part 11 11.10(e) | Change a participant's status |
| Are changes to a study's operational state controlled and attributable? | Part 11 11.10(f), Part 11 11.10(e), ALCOA+ consistent | Change the state of a study |
| Can a locked database be changed without a trace? | Part 11 11.10(c), Part 11 11.10(e), ALCOA+ original, ALCOA+ enduring | Close and lock a study |
| Is the freezing of the database a controlled act that two people sign, knowing what was still open? | Part 11 11.10(f), Part 11 11.10(g), Part 11 11.50, Part 11 11.70, ICH E6 data-governance, ALCOA+ enduring | Close and lock a study |
| Is a failed validation test kept as evidence, with what was done about it? | Part 11 11.10(a), Part 11 11.10(e), Annex 11 4, ALCOA+ original, ALCOA+ enduring | Correct a design after UAT |
| Is every correction traceable, with the reason, and the original preserved? | ICH E6 data-corrections, Part 11 11.10(e), ALCOA+ original, ALCOA+ accurate, ALCOA+ attributable | Correct data |
| Is the creation of a study attributable, and is there always someone accountable for it? | Part 11 11.10(e), ICH E6 delegation, ALCOA+ attributable | Create a study |
| Is each form's design reviewed and tested before use, and is every change recorded? | Part 11 11.10(a), Part 11 11.10(k), Annex 11 10 | Design forms |
| Can a participant be enrolled without eligibility confirmed and consent on record? | ICH E6 protocol-compliance, ICH E6 informed-consent, Part 11 11.10(f) | Enroll a participant |
| Are values checked at entry, and by the server rather than only the screen? | Part 11 11.10(f), Annex 11 6, ALCOA+ accurate | Enter visit data |
| Is every entry attributable and time-stamped, and is a change to an entry impossible to make silently? | Part 11 11.10(e), ALCOA+ attributable, ALCOA+ contemporaneous, ALCOA+ original | Enter visit data |
| Can complete and accurate copies of the records be produced in electronic form for inspection? | Part 11 11.10(b), Annex 11 8, ALCOA+ complete, ALCOA+ available | Export data |
| Can access be withdrawn immediately when a person leaves, and does it leave a record? | Part 11 11.10(d), Annex 11 12, ICH E6 data-governance, ALCOA+ attributable | Invite and manage members |
| Is each user uniquely identified, and is an identity never reused? | Part 11 11.100, Part 11 11.300, Annex 11 12, ALCOA+ attributable | Invite and manage members |
| Are essential documents kept with their versions, and can the version in force on a date be produced? | ICH E6 essential-records, Part 11 11.10(k), Annex 11 10, ALCOA+ original | Manage documents |
| Are authority checks and separation of duties built into how roles can be defined? | Part 11 11.10(g), Annex 11 12, ICH E6 investigator-oversight | Manage organization roles |
| Is a change to a role traceable: who changed it, when, what and why? | Part 11 11.10(e), Annex 11 9, ALCOA+ attributable, ALCOA+ accurate | Manage organization roles |
| Are access credentials controlled, and does the system end unattended sessions? | Part 11 11.10(d), Part 11 11.300, Annex 11 12, ICH E6 data-governance | Manage your settings and sessions |
| Can a person see and end the sessions held in their name? | Part 11 11.10(d), Part 11 11.300, Annex 11 12, ALCOA+ attributable | Manage your settings and sessions |
| Can a monitor verify data against source, with the evidence tied to the exact value and protected from the person who entered it? | ICH E6 monitoring, Part 11 11.10(e), ALCOA+ original, ALCOA+ attributable | Monitor and verify data |
| Can a site start enrolling before its ethics approval and training are on record? | ICH E6 protocol-compliance, ICH E6 delegation, Part 11 11.10(f) | Open a site |
| Is the visit schedule and its windows controlled as part of the validated design? | Part 11 11.10(k), ICH E6 protocol-compliance, Annex 11 10 | Plan visits |
| Is consent, and consent to a changed protocol, recorded and linked to what the participant then follows? | ICH E6 informed-consent, Part 11 11.10(e), ALCOA+ attributable, ALCOA+ enduring | Record consent and re-consent |
| Are protocol deviations recorded, classified and reviewed, and are reportable ones identified? | ICH E6 protocol-compliance, Part 11 11.10(e), ALCOA+ complete | Report a deviation |
| Is a change to the system's configuration validated and approved before it affects real data? | Part 11 11.10(a), Part 11 11.10(k), Annex 11 4, Annex 11 10, ICH E6 computerised-systems | Review and release a study |
| Are temporary deviations from a role controlled, time-limited and approved? | Part 11 11.10(g), Annex 11 12, ICH E6 delegation | Review organization access and audit |
| Can a reviewer confirm that the audit trail has not been tampered with? | Part 11 11.10(e), Annex 11 9, ALCOA+ original, ALCOA+ enduring | Review organization access and audit |
| Can the organization show who holds which role, where and since when, at any time? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 delegation, ALCOA+ available | Review organization access and audit |
| Can the audit trail be read and copied for inspection? | Part 11 11.10(b), Part 11 11.10(e), Annex 11 8, ALCOA+ available | Review the audit trail |
| Is there a secure, computer-generated, time-stamped audit trail that records the date, time and operator of changes, and does not obscure earlier values? | Part 11 11.10(e), Annex 11 9, ALCOA+ attributable, ALCOA+ contemporaneous, ALCOA+ original | Review the audit trail |
| Is entry outside the allowed window controlled and justified? | ICH E6 protocol-compliance, ALCOA+ contemporaneous, Part 11 11.10(f) | Run a visit |
| Is consent recorded before any procedure, and eligibility decided by the investigator? | ICH E6 informed-consent, ICH E6 investigator-oversight, Part 11 11.10(g), ALCOA+ contemporaneous | Screen a participant and record eligibility |
| Are the roles checked for separation of duties when they are created? | Part 11 11.10(g), Annex 11 12, ICH E6 investigator-oversight | Set up your organization |
| Is access to the system limited to authorized individuals, and are roles defined before people are given access? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 delegation | Set up your organization |
| Are electronic signatures on a release attributable, bound to what was signed, and checked by a second factor? | Part 11 11.50, Part 11 11.70, Part 11 11.100, Part 11 11.200, Annex 11 14 | Sign off a version and go live |
| Can one person approve their own work? | Part 11 11.10(g), Annex 11 12 | Sign off a version and go live |
| Do electronic signatures show the signer, the time and the meaning, and are they linked to the record so they cannot be copied? | Part 11 11.50, Part 11 11.70, Part 11 11.100, Annex 11 14, ALCOA+ attributable | Sign records |
| Is delegation of trial tasks recorded and signed by the investigator before a delegate can act? | ICH E6 delegation, ICH E6 investigator-oversight, Part 11 11.10(d), Part 11 11.10(g) | Staff a site |
| Is access to a study granted only to named, attributable people, with every grant and withdrawal recorded? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 12, ICH E6 data-governance | Staff a study team |
| Is the system tested for its intended use in an environment kept apart from real data? | Part 11 11.10(a), Annex 11 4, Annex 11 11, ICH E6 computerised-systems, ALCOA+ accurate | Test a version in UAT |
| Can the sponsor and the team see the state of the study without anyone preparing a separate report? | ICH E6 quality-management, ICH E6 monitoring, ALCOA+ available | Use the reports and the dashboard |
| Can the state of the whole study's data capture be seen at a glance without a separate report that could disagree with the data? | ALCOA+ complete, ALCOA+ consistent, ICH E6 quality-management | Use the casebook |
| Can an inspector see exactly what the system was configured to collect when a record was captured? | Part 11 11.10(b), Part 11 11.10(k), Annex 11 8, ALCOA+ available | View the live design |
| Can the person who raised a query also answer or close it? | Part 11 11.10(g), Part 11 11.10(d), Annex 11 12, ICH E6 data-governance | Work with queries |
| Is every action on a query attributable and time-stamped, and can the record of it be changed afterwards? | Part 11 11.10(e), Annex 11 9, ALCOA+ attributable, ALCOA+ original | Work with queries |
| Is AI used on clinical data, and could its output enter a record without a person accepting it? | ICH E6 computerised-systems, GDPR art.25, Annex 11 1 | AI |
| Can the application, or a person using its credentials, alter or delete the audit trail? | Part 11 11.10(e), Part 11 11.10(c), Annex 11 9, Annex 11 17, ALCOA+ enduring, ALCOA+ original | The database |
| Can a released design be changed in place? | Part 11 11.10(a), Part 11 11.10(k), Annex 11 10 | Environments and versioning |
| Can test activity ever be mistaken for, or mixed with, production data? | Annex 11 4, Part 11 11.10(a), Part 11 11.10(f), ALCOA+ consistent | Environments and versioning |
| Can a change to a validated, running study be introduced without losing control of what was captured under the earlier version? | Part 11 11.10(a), Part 11 11.10(k), Annex 11 10, ICH E6 computerised-systems, ALCOA+ consistent | Amend, close and lock |
| Is the final lock of the database controlled and attributable to two people? | Part 11 11.10(g), Part 11 11.200, Annex 11 14, ICH E6 data-governance | Amend, close and lock |
| Is the whole path from design to production controlled, tested and approved by independent people? | Part 11 11.10(a), Part 11 11.10(f), Annex 11 4, Annex 11 10, ICH E6 computerised-systems | Build and release a study |
| Is every change to a clinical value traceable, reasoned and independent of the person who first entered it? | Part 11 11.10(e), ICH E6 data-corrections, ALCOA+ attributable, ALCOA+ accurate, ALCOA+ original | Capture and clean data |
| Is eligibility determined by the investigator and no one else? | ICH E6 investigator-oversight, Part 11 11.10(g) | Enroll and follow a participant |
| Is informed consent recorded before any study procedure, and is a participant's consent history kept? | ICH E6 informed-consent, Part 11 11.10(f), ALCOA+ contemporaneous | Enroll and follow a participant |
| Is site staff access authorized by the principal investigator before it begins? | ICH E6 delegation, ICH E6 investigator-oversight, Part 11 11.10(d), Part 11 11.10(g) | Open and staff a site |
| Is the path from an empty system to a working, access-controlled organization controlled and recorded? | Part 11 11.10(d), Part 11 11.10(g), Annex 11 2, Annex 11 12, Annex 11 16 | From platform to first study |