cGMP Electronic Signatures

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1.0 Purpose 
 The purpose of this procedure is to define the requirements for electronic signature recording at
 Ion Labs, Inc. 
 
 2.0 Scope 
 
 This procedure applies to all electronic signatures required within electronic systems used to
 perform cGMP functions at Ion Labs, Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all employees who will use electronic signatures to complete
 an electronic cGMP record to strictly follow this procedure. 
 
 3.2 ‘It is the responsibility of Quality Management to implement this procedure and to
 ensure that the procedure is followed. 
 
 4.0 Definitions 
 
 41 ESCR-— Electronic System Controls and Requirements 
 
 4.2 eGMP — Current Good Manufacturing Practices 
 
 4.3. CFR-—Code of Federal Regulations 
 
 44 Electronic Record — any combination of text, graphics, data, audio, pictorial, or other
 information representation in digital form that is created, modified, maintained,
 
 archived, retrieved, or distributed by a computer system 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev Sai 
 cGMP Electronic Signatures QS-116 0 age 2 of3 
 
 4.5 Electronic Signature — a computer data compilation of any symbol or series of
 symbols executed, adopted, or authorized by an individual to be the legally binding
 
 equivalent of the individual’s handwritten signature 
 
 5.0 References 
 
 5.1 QS-116-F1, Form, Electronic Signature Acknowledgement 
 
 5.2 QS-115, SOP, cGMP Electronic System Controls and Requirements 
 
 6.0 Procedure 
 
 6.1 Any system in which electronic signatures are to be accepted must first be validated to
 
 ensure accuracy, reliability, consistency, intended performance, and the ability to discern
 invalid or altered records. 
 
 6.2 Electronic records that are signed must adhere to all of the controls listed for electronic
 records. In addition, the signed electronic records must include the name of the signer, the
 
 date and time of the signature (the signer's local time), and the meaning of the signature
 (e.g., review, approval, authorship) (21 CFR 11.50(a)). This information must be included
 
 in any human-readable copy of the record (21 CFR 11.50(b)). Electronic signatures and
 
 handwritten signatures executed to electronic records must be linked to their respective
 electronic records to ensure that they cannot be falsified (21 CFR 11.70)
 
 6.3 Some cGMP processes require a signature, or initials of an individual completing the
 process. If an electronic system is used to meet a cGMP requirement, then that system
 
 must apply electronic signatures, initials, and / or date to the transaction or record the same
 way paper systems would require signatures, initials, or dates. Electronic systems are
 
 capable of identifying the individual using a system based on the user name and password
 
 used to gain access to that system. Additionally, biometrics or keys may be used to identify
 individuals using a system. 
 
 6.4 For systems that utilize electronic signatures, each user of the system who will execute an
 electronic signature must first sign a certification declaring that his/her electronic signature
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev SaaS 
 cGMP Electronic Signatures QS-116 0 age 3 0 
 
 is the legally binding equivalent of his/her handwritten signature., prior to being granted the
 authority to perform electronic signatures. This serves to confirm that the signer accepts
 
 the significance of the electronic signature, besides being a regulatory requirement. There
 should be documented training of these individuals to indicate that they understand the
 
 significance of the certification. 
 
 6.5 This certification need not be submitted to the FDA, but must be retained and available in
 the event of an authority request. 
 
 6.6 Ion Labs employees are expected to keep passwords and other identification mechanisms
 confidential and secure to ensure that other individuals cannot gain access to systems or
 
 sign for activities on their behalf. The use of a username and password is considered an
 electronic signature and carries the same meaning as a handwritten signature on a
 
 document. 
 
 This requirement is communicated to Ion Labs employees during the onboarding and
6.7 training process and acknowledgement of this information is documented on form QS-116-

 F1 Electronic Signature Acknowledgement for each employee engaged in or potentially
 engaged in the use of these systems. 
 
 7.0 Revision History 
 
 Date Description of Changes CCR # By 
 Revision 
 03/14/22 | New procedure. N/A K. Burris 
 0 
 
 
 

[SOP 

 ISNLABS cGMP Electronic Signature Acknowledgement and Consent
 Form: QS-116-F1 CCR No. N/A Revision: 0 
 
 Electronic Signature Acknowledgement and Consent 
 
 Some cGMP processes require a signature, or initials of an individual completing the process. If an electronic
 system is used to meet a cGMP requirement, then that system must apply electronic signatures, initials, and / or
 
 date to the transaction or record the same way paper systems would require signatures, initials, or dates. Electronic
 systems are capable of identifying the individual using a system based on the user name and password used to
 
 gain access to that system. Additionally, biometrics or keys may be used to identify individuals using a system.
 
 Ion Labs employees are expected to keep passwords and other identification mechanisms confidential and secure
 to ensure that other individuals cannot gain access to systems or sign for activities on their behalf. The use of a
 
 username and password is considered an electronic signature and carries the same meaning as a handwritten
 signature on a document. 
 
 PROVISIONS 
 
 e You will protect and keep confidential usernames, passwords, etc. used to gain access to cGMP Electronic
 
 Systems 
 
 e Youwill not use any username and password other than your own to electronically sign a cGMP document
 or transaction. 
 
 e You agree that use of your username and password or any other biometric identifier or key carries the
 same meaning on electronic records as your handwritten signature on a document.
 
 ACKNOWLEDGMENT 
 
 By signing this Acknowledgement and Consent for Electronic Signatures, you acknowledge that you have read
 and agree to the above provisions. 
 
 WRS ERSE RES RTeAaIeZ NSaARtMe CECE RAN YS ENRON TAPUERSIEE RE SSSS S SRT AGT) EpSTPEea AEeRN ESS;
 
 Acknowledged By 
 
 
 
 Be