Data integrity requirements have been addressed in the FDA’s Title 21 CFR Part 11 and the EU's GMP Eudralex Volume 4, Chapter 4 and Annex 11. This is so far unchanged. However, with increasing automation based on computerized systems, as well as the globalization of operations and the increasing cost of bringing products to market, new guidance was needed to clarify regulatory expectations around the creation, handling and storage of data. The following eight recommendations give an overview of how to maintain data integrity for computerized systems.
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node--sub-articlePage Sections
- Introduction
- 1. Perform Risk-Based Validation
- 2. Select Appropriate System and Service Providers
- 3. Audit your Audit Trails
- 4. Change Control
- 5. Qualify IT & Validate Systems
- 6. Plan for Business Continuity
- 7. Be Accurate
- 8. Archive Regularly
1. Perform Risk-Based Validation
- Validate only systems that are part of GxP-compliance. Ensure protocols address data quality and reliability.
- In some cases it’s cost-effective to have the system vendor perform qualification and validation of the systems. To help decide between in-house or purchased validation service, use the ISPE’s GAMP5 [Good Automated Manufacturing Practice] categorizations to determine the validation complexity of your system.
- Account for all electronic data storage locations, including printouts and PDF reports during validation.
- Ensure your quality management system defines the frequency, roles and responsibilities in system validation.
- Your validation master plan must outline the approach you will use to review meaningful metadata, including audit trails, etc.
- Schedule periodic re-evaluations after your initial validation.
Page Sections
- Introduction
- 1. Perform Risk-Based Validation
- 2. Select Appropriate System and Service Providers
- 3. Audit your Audit Trails
- 4. Change Control
- 5. Qualify IT & Validate Systems
- 6. Plan for Business Continuity
- 7. Be Accurate
- 8. Archive Regularly
2. Select Appropriate System and Service Providers
- Ensure your providers are fluent with the relevant regulations.*
- Systems must be fit-for-purpose. Get proof of a software’s efficacy for the application it will be used in.
- Learn about your suppliers’ organizational culture and maturity relating to data management. Ask them what systems are in place to ensure data integrity and audit those systems if possible.
* See EU GMP EudraLex Annex 15: “Where validation protocols and other documentation are supplied by a third party providing validation services, appropriate personnel at the manufacturing site should confirm suitability and compliance with internal procedures before approval.”
Learning with Cisco Netacad, there are many exams and lab activities to do. Some instructor require students to complete all Chapter exams, Final Exam and Chapter Quiz. No mater what instructors want you to do, ITexam24.com offers all exams answers with clear explanation. Our Experts have verified all exam answers before we published to the website. We recommended you to chose any relevant chapter from the following:
What service determines which resources a user can access along with the operations that a user can perform?
- authentication
- biometric
- accounting
- token
- authorization
Explanation:Authorization determines whether a user has certain access privileges.
What type of cybersecurity laws protect you from an organization that might want to share your sensitive data?
- confidentiality
- nonrepudiation
- authentication
- privacy
- integrity
Explanation:Privacy laws control appropriate use of data and access to data.
What three design principles help to ensure high availability? [Choose three.]
- eliminate single points of failure
- provide for reliable crossover
- ensure confidentiality
- check for data consistency
- use encryption
- detect failures as they occur
Explanation:High availability systems typically include these three design principles.
For the purpose of authentication, what three methods are used to verify identity? [Choose three.]
- something you know
- something you do
- something you have
- where you are
- something you are
Explanation:The forms of authentication are something you know, have , or are.
What is a secure virtual network called that uses the public network?
- IPS
- IDS
- MPLS
- NAC
- Firewall
- VPN
Explanation:The term VPN describes a virtual network that uses encryption to protect data when traveling across Internet media.
What mechanism can organizations use to prevent accidental changes by authorized users?
- SHA-1
- backups
- version control
- hashing
- encryption
Explanation:Version control ensures that two users cannot update the same object.
What is a method of sending information from one device to another using removable media?
- wired
- infrared
- LAN
- packet
- wireless
- sneaker net
Explanation:Sneaker net refers to hand delivering the removable data.
What are the three foundational principles of the cybersecurity domain? [Choose three.]
- policy
- integrity
- availability
- confidentiality
- security
- encryption
Explanation:Three foundational security principles are confidentiality, integrity and availability.
What are three access control security services? [Choose three.]
- access
- authentication
- repudiation
- authorization
- accounting
- availability
Explanation:This question refers to AAA authentication, authorization, and accountability.
Which two methods help to ensure data integrity? [Choose two.]
- availability
- data consistency checks
- privacy
- hashing
- authorization
- repudiation
Explanation:Data integrity systems include one of the two data integrity methods.
What three tasks are accomplished by a comprehensive security policy? [Choose three.]
- useful for management
- defines legal consequences of violations
- is not legally binding
- gives security staff the backing of management
- vagueness
- sets rules for expected behavior
Explanation:Policy sets the establishment of rules and guidelines for the business.
What two methods help to ensure system availability? [Choose two.]
- integrity checking
- system backups
- up-to-date operating systems
- system resiliency
- fire extinguishers
- equipment maintenance
What principle prevents the disclosure of information to unauthorized people, resources, and processes?
- integrity
- confidentiality
- nonrepudiation
- accounting
- availability
Explanation:The security principle of confidentiality refers to the prevention of the disclosure of information to unauthorized people, resources, and processes.
What are the three states of data? [Choose three.]
- suspended
- in-cloud
- at rest
- in-transit
- in-process
- encrypted
Explanation:The protection of the cyber world requires cybersecurity professionals to account for the safeguarding of data in-transit, in-cloud, and at rest.
What name is given to any changes to the original data such as users manually modifying data, programs processing and changing data, and equipment failures?
- deletion
- modification
- dissemination
- corruption
- backup
- integrity
Explanation:Modification involves changes to the original data and not complete deletion of the data.
What is identified by the first dimension of the cybersecurity cube?
- goals
- safeguards
- rules
- tools
- knowledge
Explanation:The first dimension of the cybersecurity sorcery cube identifies the goals or security principles required to protect the cyber world.
What name is given to a storage device connected to a network?
- NAS
- SAN
- RAID
- Cloud
- DAS
Explanation:NAS refers to a storage device connected to a network that allows storage and retrieval of data from a centralized location by authorized network users.
What are two methods that ensure confidentiality? [Choose two.]
- authorization
- availability
- nonrepudiation
- authentication
- integrity
- encryption
Explanation:Confidentiality means viewing of information only for those who need to know. This can be accomplished by encrypting data and authenticating users who request access.
What are three types of sensitive information? [Choose three.]
- business
- published
- declassified
- public
- classified
- PII
Explanation:Sensitive information is information that would otherwise cause harm to a company or individual if publicly disclosed.
Which of the following ensures data integrity?
Error checking methods and validation procedures are typically relied on to ensure the integrity of data that is transferred or reproduced without the intention of alteration.What are the two methods that ensure confidentiality?
Some information security basics to keep your data confidential are: Encryption. Password. Two-factor authentication.How did you ensure data integrity?
In order to ensure Data Integrity, there is also a need to do a risk assessment, a validate of the input source of the data, as well as an audit of the audit trail. Additionally, the organization needs secure the data by encrypting it and also performing penetration testing by ethical hackers.Which technique is used for ensuring integrity?
Checksumming is a well known method for performing integrity checks.