Employee Signature Recording

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1.0 Purpose 
 
 The purpose of this procedure is to establish the guidelines for the use of signatures and initials
 
 on all cGMP documents. This procedure will also establish a system for the recording of every
 employee’s signature and initials. 
 
 2.0 Scope 
 
 This procedure applies to all employees at Ion Labs, Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of HR to notify Document Control and the Training Department
 upon the hire of a new employee, the termination of an existing employee, and for any
 
 changes to an employee’s name. 
 
 3.2 ‘It is the responsibility of the Department Manager and/or HR to inform Document
 
 Control and the Training Department every time an employee is transferred from one
 
 department to another. It is the responsibility of Quality and Department Managers to
 ensure that this procedure is followed by all employees, and that all signatures and
 
 initials recorded by employees on cGMP documents are legible and correct.
 
 3.3. ‘It is the responsibility of the Training Department to record all employee signatures and
 
 initials and forward them to Document Control. 
 
 3.4 It is the responsibility of Document Control to maintain on file all employee signatures
 
 and initials, and to update them as necessary. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev al 
 Employee Signature Recording A-114 4 age 20 
 
 4.0 Definitions 
 
 4.1 cGMP — Current Good Manufacturing Practices 
 
 4.2 | HR-— Human Resources 
 
 5.0 References 
 
 5.1 A-114-F1, Form, Employee Register 
 
 6.0 Procedure 
 
 6.1 Employee signatures and initials must be unique to each employee and easily
 
 identifiable. 
 
 6.1.1 The recommended format for initial use is the first letter from the employee’s
 first name, the first letter from the employee’s middle name, and the first letter
 
 from the employee’s last name. 
 
 6.1.2 Duplication of initials between two or more employees is not permitted.
 
 6.1.2.1 In the event that there is more than one employee with the same initials,
 other designated letters must be used to differentiate the initials of these
 
 employees. 
 
 @ In the event that an employee does not have a middle name, any
 
 other combination of letters may be used, as long as the initials
 
 will be unique to the employee. 
 
 6.2 If an employee wishes to change their name, signature, or initials, HR and the Training
 
 Department must be notified immediately. 
 
 6.3 Every new employee must be trained on this procedure. At training completion, the
 
 employee’s signature and initials will be recorded on Form A-114-Fl Employee
 Register. 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev ay 
 Employee Signature Recording A-114 4 ge3o 
 
 6.3.1 Only the signature and initials recorded on the Employee Register are permitted
 
 to be written on all cGMP documents. 
 
 6.4 If an employee transfers from one department to another, the department manager
 and/or HR must notify Document Control and the Training Department of the transfer.
 
 The employee’s department will be updated on the Employee Register.
 
 6.5 Every time an employee enters his/her signature or initials onto the Employee Register,
 
 it must be in the presence of the Training Department or designee. Otherwise, the
 
 entries will not be valid. 
 
 6.6 Document Control will keep each Employee Register. These records will be kept
 
 current and secure at all times, separate from employee records. 
 
 6.7. Form A-114-Fl Employee Register will contain the following information:
 
 6.7.1 Employee’s Printed Name 
 
 6.7.2 Employee’s Signature 
 
 6.7.3. Employee’s Distinguished Initials 
 
 6.7.4 Employee’s Start Date 
 
 6.7.5 Employee’s End Date 
 
 6.7.6 Department 
 
 6.7.7 Transfer Date (as applicable) 
 
 6.7.8 New Department (as applicable) 
 
 6.7.9 Recorded By 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 : ; A-114 4 Page 4 of 4 
 Employee Signature Recording 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 3 | 01/03/19 | Scheduled review: added training department to procedure. Removed unnecessary definitions. | 19-0017 | K. Burris |
| 4 | 04/18/22 | Scheduled review: Cleaned up procedure. Updated logo. CC- | 22-0195 | K. Burris |

 

[SOP 

 IAN LABS Employee Register 
 
 Form: A-114-F1 CCRNo. CC-22-0195 Revision: 4 
 
 Employee Name: 
 
 It is a GMP requirement to have a record of each employee’s signature and initials. Only the signature
 and initials recorded on this register are permitted to be written on GMP documents.
 
 Your signature and/or initials on a GMP document mean that you have performed the task in accordance
 with documented requirements. 
 
 You are only permitted to sign or initial a document if you have been trained to perform the task.
 
 Do not sign or initial a document if you have not performed the task. 
 
 You are not permitted to sign someone else’s signature or initials. 
 
 Start Date: 
 
 End Date: 
 
 Department: 
 
 Transfer Date: 
 
 New Department: 
 
 Entered by: 
 
 Transfer Date: 
 
 New Department: 
 
 Entered by: