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Part 11 requires certain IT policies regarding electronic records and electronic signatures. This policy document includes the IT policies needed in most companies, including those needed to meet Part 11 requirements and to protect validated computer systems from unauthorized intentional and unintentional change. This policy covers the practices for the procurement, support, and use of computer systems needed to ensure their efficacy, reliability, and security. 10 pages
Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $99.00

Product Detail:
  • The purpose of this policy is to define the company's requirements for the management and use of computer systems.
  • This policy applies to the use of company owned hardware and software, including the information systems administered by the IT department , departmental systems , and systems used individually by employees.
  • Data and information generated within the company is considered part of our corporate assets and is appropriately protected from theft, corruption, or destruction.
  • The IT department procures , configures, and supports company owned workstations and laptops. IT, while maintaining a base configuration for such hardware, may add additional hardware features to individual workstations to meet the business needs of users.

It Provides information on:

  • Responsibilities
  • General policy on the use of systems
  • Uses of company computer resources
  • Electronic records and electronic signatures
  • Control and Support of Systems
  • Network Management
  • System acquisition, implementation, and Validation


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