Modern pharmaceutical and biotechnology equipment increasingly relies on software to control operations, collect data, calculate results, generate reports, and maintain electronic records. From laboratory instruments and environmental monitoring systems to autoclaves and manufacturing equipment, software is often essential to the equipment’s intended use.
When that software is updated, the equipment’s validated state may be affected. A structured, risk-based validation process helps confirm that the updated system continues to operate correctly, protect data integrity, and meet applicable Good Manufacturing Practice requirements.
Why Software Updates Require Evaluation
Software updates can include security patches, bug fixes, operating-system changes, firmware upgrades, database modifications, new features, and changes to calculations or user interfaces. Even a seemingly minor update can affect critical functions.
Potential risks include:
Changes to calculations or processing logic
Loss or alteration of stored data
Communication failures between connected systems
Changes to audit trails or electronic signatures
Modified security permissions
Unexpected changes to alarms or equipment controls
Incompatibility with hardware, operating systems, or interfaces
Changes to report formats or exported data
For this reason, regulated organizations should not install updates on GMP equipment without first evaluating their potential impact.
Under 21 CFR 211.68, appropriate controls must be maintained over computerized systems, and changes to records must be properly controlled. EU GMP Annex 11 also identifies change control, risk management, validation documentation, security, audit trails, and periodic evaluation as important computerized-system controls. EU GMP Annex 11
Begin With Formal Change Control
Every software update affecting regulated equipment should begin with an approved change-control record. The record should describe:
The current and proposed software versions
The reason for the update
Equipment and systems affected
New features, corrections, and known issues
Potential impact on product quality and patient safety
Potential impact on electronic records and data integrity
Required validation or verification activities
Rollback and contingency procedures
The change should be reviewed by appropriate stakeholders, which may include equipment owners, laboratory personnel, engineering, information technology, validation, and Quality Assurance.
Installing an update before its impact has been assessed can place the equipment outside its approved configuration.
Perform a Documented Risk Assessment
Not every software update requires complete equipment revalidation. The scope of testing should be based on the update’s risk and its potential impact on the validated state.
A low-risk security patch that does not affect the application’s functionality may require documented verification and limited regression testing. An update that changes calculations, operating parameters, data storage, user permissions, electronic signatures, or audit trails may require more extensive qualification.
The risk assessment should consider:
The equipment’s intended use
Critical process parameters
GMP records created or maintained by the system
The update’s technical scope
Vendor release notes and testing
System configuration and customization
Interfaces with other applications or equipment
Previous deviations or recurring software problems
EU GMP Annex 15 supports basing the scope and extent of qualification and validation on a justified, documented risk assessment. EU GMP Annex 15
Define the Required Validation Testing
Testing should demonstrate that the equipment remains suitable for its intended use after the update. Depending on the nature of the change, the validation plan may include installation qualification, operational qualification, performance qualification, functional verification, or regression testing.
Installation Qualification
Installation qualification confirms that the approved software version was installed correctly. Testing may verify:
Software and firmware version numbers
Hardware and operating-system compatibility
System configuration
Database connections
Network settings
Security and antivirus compatibility
Backup and recovery functionality
Installation records and vendor documentation
Operational Qualification
Operational qualification demonstrates that affected functions operate according to approved requirements. Tests may include alarms, calculations, access controls, audit trails, electronic signatures, report generation, data transfers, and equipment control functions.
Testing should include normal conditions, boundary conditions, and appropriate challenge or error conditions.
Performance Qualification
Performance qualification may be necessary when the software update could affect the equipment’s performance during routine use. Representative workflows, products, loads, methods, or operating ranges should be evaluated under actual or simulated production conditions.
For laboratory instruments, this could include running system-suitability tests or qualified methods. For an autoclave, it may include confirming cycle control, alarm operation, and data recording. For temperature-monitoring systems, it may involve verifying sensor communication, calculations, alarms, and reports.
Protect Data During the Update
A validated backup should be completed before installing the update. Organizations should confirm that historical data, metadata, audit trails, methods, configurations, and user accounts remain complete and accessible.
Data migration, conversion, or database restructuring may require reconciliation testing. The company should be able to demonstrate that records were not lost, duplicated, truncated, or improperly changed.
Rollback procedures should also be established before installation. If the update fails, the organization needs a controlled way to restore the previous validated configuration.
Review Documentation and Train Users
Software updates may require revisions to standard operating procedures, work instructions, configuration specifications, validation documents, system inventories, and disaster-recovery plans.
Users should receive documented training when the update changes workflows, interfaces, permissions, reports, or equipment operation. Equipment should not be returned to GMP service until testing is successfully completed, deviations are resolved, documentation is approved, and Quality Assurance authorizes release.
Maintaining the Validated State
Validation after equipment software updates is not simply an IT task. It is a controlled quality activity that protects product quality, reliable equipment performance, and data integrity.
GL Technologies provides equipment qualification, validation, calibration, and compliance support for pharmaceutical, biotechnology, and laboratory facilities. A risk-based validation strategy can help your organization implement necessary software updates while maintaining documented control over critical equipment and computerized systems.
About GL Technologies
GL Technologies, based in San Diego, is a specialized service provider catering to the highly regulated industries of biopharmaceuticals, pharmaceuticals, medical devices, and government sectors. The company focuses on delivering expert solutions in equipment calibration, validation, and compliance services, ensuring that clients meet stringent GMP (Good Manufacturing Practice) and FDA regulations. GL technologies is a trusted partner from commissioning new plants to decommissioning with compliance. GL can place dedicated motivated quality personnel on site anywhere. A program can be designed or revamped for the customers needs from design of CMMS to SOP development, specification development and performance of calibrations.
With a dedicated team of 29 technicians, GL Technologies offers precision calibration, preventative maintenance, and qualification services for laboratory and production equipment used in critical manufacturing and research processes. The company’s expertise is supporting its clients in maintaining regulatory compliance and operational efficiency.
As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. GL Tec specializes in IQ OQ PQ services for clients throughout San Diego, San Francisco, Los Angeles, Orange County, and Riverside!