cGMP Training

Computer System Validation Purpose of CSV: The computerized systems used in regulated environments consistently produces accurate, reliable, and compliant results. Accurate: The system consistently delivers results that are correct, complete, and fit for their intended purpose. Compliance: The system meets all regulatory and industry standards. Reliability: The system works consistently performs its intended functions without failure under defined operating conditions..

[image] CHEMO. Main Elements of Computer system validation.

Risk Management : Risk management should be applied throughout the lifecycle of the computerized system taking into account of patient safety, data integrity and product quality. Decisions on the extent of validation and data integrity controls should be based on a risk assessment. 2. Personnel There should be close co-operation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties..

3. Suppliers and Service Providers : When third parties are used e.g. to provide, install, configure, integrate, validate, maintain , modify or retain a computerised system formal agreements must exist. Quality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request. 4. Validation: User Requirements Specifications should describe the required functions. The regulated user should take all reasonable steps, to ensure that the system has been developed in accordance with an appropriate quality management system Evidence of appropriate test methods and test scenarios should be demonstrated.

5. Data: Computerised systems exchanging data electronically with other systems should include appropriate built-in checks for the correct and secure entry and processing of data. 6. Accuracy Checks For critical data entered manually, there should be an additional check on the accuracy of the data. This check may be done by a second operator or by validated electronic means. 7. Data Storage Data should be secured by both physical and electronic means against damage. Stored data should be checked for accessibility, readability and accuracy. Regular back-ups of all relevant data should be done.

8. Audit Trails: The creation of a record of all GMP-relevant changes and deletions shall be considered.(a system generated "audit trail"). Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed. Audit Trails are secure, computer-generated, time-stamped electronic records that independently document the creation, modification, or deletion of data, including the identity of the user and the date and time of the activity. 9. Periodic evaluation: Computerised systems should be periodically evaluated to confirm that they remain in a valid state and are compliant with GMP..

10. Security : Physical and/or logical controls should be in place to restrict access to computerised system to authorised persons. Creation, change, and cancellation of access authorisations should be recorded. 11. Electronic Records & Electronic Signature: Electronic Records and Electronic Signatures (ERES) are digital records and signatures that are created, maintained and managed electronically ensuring authenticity, integrity, confidentiality, and regulatory compliance. Electronic records may be signed electronically. Electronic signatures are expected to: a. Have the same impact as hand-written signatures within the boundaries of the company. b. Be permanently linked to their respective record. c. Include the time and date that they were applied..

12. Batch Release : When a computerised system is used for recording certification and batch release, the system should allow only Qualified Persons to certify the release of the batches and it should clearly identify and record the person releasing or certifying the batches. This should be performed using an electronic signature..

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Guidelines (21 CFR Part 11 , EU Annex 11,GAMP5). 21 CFR Part 11 : it is a FDA Regulation that mandates specific controls – like validation, audit trails and security for ERES to ensure they are trustworthy and reliable. EU Annex 11: Annex 11 is a European regulatory requirement for organizations that mandates how the computerized system must be validated, secured and managed. It emphasizes the validation, risk management, change control, data protection, audit trails and security business continuity. GAMP stands for Good Automated Manufacturing Practice: The guidance document on Risk-Based approach to compliant GxP computerized systems. This document is published by an industry trade group called “International Society for Pharmaceutical Engineering (ISPE)”..

Software Categories. Category Description GAMP1 Infrastructure Infrastructure Software-OS, DB,IT Tools etc. Examples: Database Systems, Programming Languages, Windows OS. GAMP3 Non-configurable Standard Firmware Based software package. No customization. Examples: HMI, PLC’s, COTS, Firmware/ Middleware software's. GAMP4 Configurable Standard software package. Customization of configuration. Example: LIMS,ERP Systems GAMP5 Customized Software developed specifically for a user’s requirements Example: in-house developed applications, Add-ons to GAMP Categories 3.

IT Compliance @CIF. SOP’s For GxP system administration. CSV deliverables Regular Backups(Daily and Monthly scheduled Jobs) in GxP Systems Annual Restorations Preventive maintenance of GxP systems Windows Control verifications Audit Trail Verification Complete inventory list of all GxP systems Decommissioning process of GxP Systems.

Reference. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11.

[image] Thank You!. Thank You very much for the Successful completion of the Annual cGMP session Team-IT.