Manage qualifications
Does your organization work according to GMP (Good Manufacturing Practices) guidelines that have been drawn up for the pharmaceutical industry and other highly regulated industries?
Then it is necessary to accurately track employee compliance. However, managing this is often time-consuming and an unclear process.
Employability Manager is the software system that provides the support to demonstrate employee compliance. In addition, it has all the components that are necessary to be allowed to use within high-risk industries:
Audit Trail
To keep track of what is happening in the system, all critical actions are logged.
The Audit trial records all changes and schedules, registrations and log-ins, etc. It also records who makes the change and when. Even if these actions are performed automatically by the system, for example when rescheduling a training course.
This gives you control to check at all times what has been changed, by whom and when.
Electronic Signature
In order to be able to perform critical actions in the system, it is possible to use an electronic signature.
This will prompt a pop-up for the username and password of the authorized persons. For all e-signatures, the audit trail keeps track of which action it is for, who signed and when. As soon as the correct person has entered his username and password, the action is performed.
Electronic signature is used, for example, for releasing tests, registering training courses, etc.
Validation
Employability Manager has been extensively validated and tested, both by ourselves and by our customers.
In order to guarantee quality, fixed procedures are followed for each new version to develop, test, validate and roll out the software. Customers are also given the opportunity to independently validate the new developments, if required.
Since 1998, several customers have validated Employability Manager.
CFR Part 11 compliance
Below we outline Employability Manager’s position on CFR Part 11 compliance, for the specific sections where the platform itself is responsible for meeting the requirement.
| Section | Requirement | Employability Manager |
|---|---|---|
| 11.10 (b) | The system shall generate accurate and complete copies of records in human readable and electronic form suitable for inspection, review and copying | EMMA provides advanced and extensive reporting both on screen and available in pdf/excel format. Reports include user progress, learning history etc. |
| 11.10 (d) | The system shall limit system access to authorized individuals. | Authentication is controlled by username and password, optionally two-factor authentication. Single Sign on is also possible. Password settings, i.e. strenghts and expiration time can by set by admin user. User permissions within the system are managened by user-right. These determine the features available for all users. Authizations determin the data available. |
| 11.10 (e) | The system shall employ secure, computer-generated date/time stamped audit trails to independently record operator entries and actions that create, modify, or delete electronic records, without obscuring previously recorded information. | EMMA provides an extensive audit trail that logs all actions performed. This includes time, date, user, old value, new value. The audit trail is in readable format and searchable. |
| 11.10 (f) | The system shall enforce required steps and events sequencing, as appropriate (e.g., key steps cannot be bypassed or similarly compromised). | EMMA enforces specific steps when applying certain operations. Each operation triggers a standard set of events which are logged and can be reviewed anytime in the future. |
| 11.10 (g) | The system shall ensure that only authorized individuals can use the system, electronically sign a record, access the operations or computer system input or output device, alter a record, or perform the operation at hand. | Users are authenticated with username and password to determine their access rights. Employees are assighed to user groups which in turn are assigned to permissions within the application. This includes certain actions, menu’s, screens are options. Authorizations are used to detemine the data visible and changable within the system. |
| 11.10 (h) (1) | The system shall determine, as appropriate, the validity of the source of data input or operational instruction. | Access control checks ensure that the user performing an action is authorised to do so. Form validation is used to ensure only valid data is accepted. |
| 11.50 (a) (1), (2), (3) | The system shall ensure all signed electronic records contain the printed name of the signer, date/time signature was executed, and the meaning associated with the signature (e.g. approval, responsibility, authorship). | Actions that require confirmation with electronic signature/password contain the name of the user, date and time, the action and meaning of the electronic signature. |
| 11.50 (b) | The system shall ensure the three signature elements (described in the previous requirement) of a signed electronic record are a part of any human readable form of the electronic record (e.g. electronic display or printout). | The three signature elements (i.e., action, date/time, user/username) are included in all the EMMA audit trail reports. |
| 11.70 (a) | The system shall ensure electronic signatures are linked to their respective electronic records and that these electronic signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. | In EMMA, an electronic signature is linked to and protected by the respective username and password. Electronic records cannot be manipulated, copied, transferred or falsified. |