Computer system validation consultancy

Computerized Systems Validation, as outlined in GAMP 5 second edition (v2.0), is a crucial process that entails creating well-documented evidence to instill a high level of confidence that a specific process will consistently yield a product that adheres to its defined specifications and quality standards.

Our comprehensive range of services encompasses the validation of various computer systems, including but not limited to:

  1. Validation of ERP Software (e.g., SAP, Oracle): Ensuring that enterprise resource planning (ERP) software functions effectively and in compliance with industry standards.

  2. Validation of Computerized Systems: Validation of critical systems such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Warehouse Management Systems (WMS), and Building Management Systems (BMS) to guarantee their reliability and accuracy.

  3. Validation of Mobile Applications, including Software as a Medical Device: Ensuring the validation and compliance of mobile applications, especially those classified as medical devices.

  4. Validation of Computer Process Control Systems: Validating systems that control and manage crucial industrial processes.

  5. IT Infrastructure Qualification: Qualification of Information Technology (IT) infrastructure, including Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS) cloud qualifications.

  6. Validation of Legacy Computerized Systems: Ensuring that older computerized systems remain compliant and reliable.

  7. Validation of Serialization and Aggregation Computer Systems: Validating systems used for serialization and aggregation in industries such as pharmaceuticals, including systems like Intrex Pharma 2D, SeaVision vision control systems, and Systech.

  8. Agile Validation for Software Providers and Regulated Pharmaceutical Companies: Providing validation services tailored to agile development methodologies for both software providers and pharmaceutical companies adhering to regulatory requirements.

  9. Validation of Medical Devices Containing Software: Ensuring that medical devices integrated with software meet stringent validation and compliance criteria.

  10. Validation of Mobile Devices/Systems, including Software as a Medical Device (SaMD): Validating mobile devices and systems, particularly those categorized as Software as a Medical Device.

Our expertise in Computerized Systems Validation spans a wide spectrum of industries and technologies. We are committed to ensuring that your systems and processes meet the highest standards of quality, compliance, and reliability. Trust us to be your partner in achieving validation excellence.

Discover our top-notch Computerized Systems Validation training courses available on Udemy. We provide comprehensive learning solutions, all in English. Our featured courses include

  1. Validation and maintenance of computerized system link: Dive deep into the world of computerized systems validation with this course. Learn the ins and outs of validating and maintaining computerized systems according to the latest GAMP 5 standards, version two. Computer system validation and maintenance based on the GAMP 5 link
  2. Computer System Assurance link- Quality Assurance of Computerized Systems: Ensure the highest quality and reliability of your computerized systems with this specialized training. Our Udemy course covers the essentials of computer system assurance, equipping you with the knowledge and skills you need to excel in this critical area.
  3. Agile validation in GxP link - Agile validation in GxP applies to companies developing software for GxP-regulated industries, pharmaceutical companies creating software for their internal use, and GxP-regulated companies seeking to employ agile validation for developing and validating software for their internal purposes.
  4. Data integrity for computerized systems in GxP link- Data integrity in computerized systems refers to the accuracy, reliability, and consistency of data throughout its lifecycle. It is paramount to ensure that digital information remains unaltered, reliable, and authentic, especially in critical sectors like healthcare, finance, and research
  5. Qualification of cloud infrastructure based on GAMP link - Infrastructure Qualification Based on Cloud: we have been familiar with the concept of IT infrastructure qualification for years. However, with the advent of cloud computing, numerous concepts have evolved, including infrastructure models such as on-premises, Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS). To efficiently validate systems, it is crucial to understand these concepts, qualifications, and validation approaches. Additionally, it is essential to know how to utilize cloud providers like Amazon, Google, and Microsoft for this purpose.
  6. Validation of the Mobile Applications link is essential, as these applications can operate independently as computerized systems, integrate with other systems, and serve as medical devices, known as SaMD (Software as Medical Device). Moreover, mobile applications come with specific requirements and risks that CSV specialists need to be mindful of. An essential aspect is comprehending how these applications store data and establish connections with databases.
  7. Spreadsheet Validation based on GAMP 5 link  Spreadsheets are specialized computerized systems utilized in GxP to store and calculate data. Validating such systems involves specific considerations related to design, requirements, risk, and test cases.

 

Join us on Udemy and take your expertise in computerized systems validation to the next level. Enroll now and stay at the forefront of this dynamic field.

Types of Systems:

  1. Production Systems
  2. Warehouse and Accounting Systems (Orders, Purchases, Sales, Returns, Complaints, Holds or Recalls, Disposals)
  3. Data Scanning Devices Linked to the System
  4. Transportation Management Support Systems
  5. Environmental Condition Monitoring and Control Systems (Throughout the Distribution Process)
  6. Document Management
  7. Software Used in Clinical Research

 

Industries Where Validation is Applied:

  1. Validation of Computerized Systems for the Pharmaceutical Industry
  2. Validation of Computer Systems for Drug Wholesalers
  3. Validation of Computerized Systems for the Cosmetics Industry
  4. Validation of Computer Systems for the Tobacco Industry
  5. Validation of Computerized Systems for Medical Devices, Including Software as a Medical Device
  6. Validation of Computer Systems for the Medical Marijuana Industry