Control of Laboratory Electronic Documentation

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1.0 Purpose 
 
 This procedure establishes a process that ensures laboratory electronic documentation is
 controlled and protected. 
 
 2.0 Scope 
 
 This procedure applies to all laboratory documents that are in electronic form.
 
 3.0 Responsibility 
 
 3.1 Itis the responsibility of Management to ensure the functionality of the computer systems
 that control laboratory activities or processes within Ion Labs through a software
 validation. 
 
 3.2 Itis the responsibility of the Quality Systems Manager to implement this procedure and to
 
 ensure that the procedure is followed. 
 
 4.0 Definitions 
 
 None 
 
 5.0 References 
 
 5.1 QS-108, SOP, Corrective and Preventive Action 
 
 6.0 Procedure 
 
 6.1 Electronic Documentation and Data 
 
 6.1.1 Ion Lab’s Management is responsible for approving the functionality of the
 computer systems that control laboratory processes within the organization.
 Approval is indicated by the existence and functionality of the system(s) in use.
 
 6.1.2 Management manages the data generated in the electronic system and electronic
 backups. All personnel have access to the data and information needed to
 perform assigned laboratory activities. 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev es 
 Control of Laboratory Electronic Documentation D-123 0 8 
 
 6.1.3 The Lab’s information management system used for the collection, processing,
 recording, reporting, data storage, or retrieval of data is validated for
 functionality, including the proper functioning of interfaces within the Lab’s
 information management system(s) by the Lab before introduction. This
 
 validation will be documented in the Lab Software Validation Log which
 identifies the application(s) and records the results of the validation(s).
 
 6.1.4 Whenever there are any changes, including laboratory software configuration or
 modifications to the commercial off-the-shelf software, they will be authorized,
 documented, and validated on the Lab Software Validation Log before
 
 implementation. 
 
 6.1.4.1 Justification may be used if a validation is not required for changes to
 the commercial off-the-shelf software. 
 
 6.1.5 Documents, data and records managed electronically are protected from
 unauthorized access, tampering and loss, unauthorized changes, unintended
 
 alterations, corruption, and physical damage as described in Table 1 below.
 
 

[SOP 

 Standard Operating Procedure SOP No 
 D-123 0 Page 3 of 4 
 Control of Laboratory Electronic Documentation 
 
 Table 1 
 ___ Application | | Access Control 
 LMS documents, data, 
 and records only on 
 Microsoft Office | LMS documents, data compulers nine ae 
 ; Username and N/A 
 Suite and records 
 password, 
 Read/write folder 
 permissions or no access 
 Interface for the 
 ; Display Data Loggers ; 
 DicksonOne Cloud Cloud based System. Data is
 Web Application Ee aoe peemetie aad Passwore stored by compan 
 PP Touchscreen Data y pany: 
 Loggers (TWE/TWP) 
 Windows-based Server 
 ; - Username and 
 Acquire Digital data nee control 
 Agilent OpenLabs | from chromatographic ike eae Software firewall 
 ; Read/write folder 
 equipment —_ Daily Server backup 
 permissions or no access Aaauction 
 , . Username and Windows-based Server 
 ae Acquire Digital data 
 ThermoScientific from chromatooranhic password, control 
 Chromeleon ; erp Read/write folder Software firewall 
 equipment — na ; 
 permissions or no access Anti-virus protection
 Username and Windows-based Server 
 , Acquisition of data for password, control 
 /gilent: Masshunites ICP-MS Read/write folder Software firewall 
 permissions or no access Anti-virus protection
 Windows-based Server 
 Username and control 
 ThermoScientific Acquisition of data password, Software firewall 
 Omnic from Nicolet FTIR Read/write folder 
 rr Daily Server backup 
 permissions or no access Anti-virus protection
 Acquire Digital Data | Username and password ——o pemver 
 Win-Lab from UV/Vis Read/write folder 
 ; . Software firewall 
 instrument permissions or no access a ; 
 Anti-virus protection 
 Windows-based Server 
 Force Recorder CUNT IEW Data Username and password Pony 
 Professional toma Textile for computer system Software firewall 
 Analyzer P y Daily Server backup 
 Anti-virus protection 
 Windows-based Server 
 Username and erat 
 Agilent Mass Acquire Digital Data password, Soft fj 1 
 Hunter from QQQ Read/write folder SEN gaa cra 
 Daily Server backup 
 permissions or no access 
 Anti-virus protection 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 D-123 Page 4 of 4 
 Control of Laboratory Electronic Documentation 
 
 6.1.6 Electronic LMS documents, data and records residing on computers, servers,
 and/or the network are protected through the following methods:
 
 ® Windows-based server control; domain and user account restrictions,
 a Software firewall built into server, 
 
 ® Daily Server backup: scheduled and controlled by Ion Labs,
 ® Each computer workstation has anti-virus protection, 
 @ Cells in spreadsheets are protected from alteration as necessary,
 
 @ Limited access to archive or obsolete folders. 
 6.1.7 The information management systems are operated in an environment that
 complies with the application providers’ or the Lab’s specifications and the
 operating systems have proven to be effective through years of successful use.
 
 6.1.7.1 System failures are identified, and appropriate immediate corrections
 and corrective actions are taken in accordance with the QS-108
 Corrective and Preventive Action procedure. 
 
 The methods described above ensure the integrity of the data and information is
 maintained. Additional methods to protect data integrity include, but are not
 limited to: 
 
 6.1.8.1 Record integrity is tested during application upgrades to ensure that
 data contained in records is legible and appears in the same format as
 when the data was originally entered. 
 
 6.1.8.2 Records scanned into portable data formats (pdf) are reviewed to
 ensure the scan is legible and both sides of double-sided originals are
 captured. 
 6.1.8.3 Discontinued applications are reviewed to determine the data
 contained and where necessary, data mapping is completed, or
 alternate solutions are developed. 
 6.1.9 Calculations and data transfers are checked in an appropriate and systematic
 manner. This occurs during routine testing and when Lab Management deems
 
 appropriate. 
 6.1.10 The Lab’s information management system is maintained off-site and on-site.
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 11/30/21 | New N/A J. Sassman | - | - |