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Validation Manuals Policies and Procedures


Policies, procedure statements, and detailed instructions are written when new business practices and processes are introduced in an organization

Whether conforming with International Organization for Standardization (ISO) 9000 Quality Management Standards, ISO 14000 Environmental Management Standard Document/Data Control requirements, U.S. Food & Drug Administration (FDA) regulations, or your own in-house policies, VATechWrite has extensive experience in creating policies, procedures, and work instructions that capture the essence of your business practices, processes, and tasks.

Key Benefits

     Policies ensure consistency and uniformity in decisions

     Policies assist in the assessment of performance and establish accountability

     Procedures ensure repeatable process results each time

     Procedures save time and money by minimizing training

     Policies, procedures, and work instructions conform with regulatory requirements

 

Capabilities

      Policies

Policies answer the question, "Why do we do this?" Policies consist of a statement of purpose and one or more broad guidelines as to how the guidelines will be achieved. Guidelines specify in general terms, the kind of action which will or may be taken; they imply an intention and a pattern for taking action. Policy matters are invariably associated with a combination of problems. A policy may be required where there is a diversity of interests and preferences which result in vague and conflicting objectives among those who are directly involved. VATechWrite can effectively assess and analyze your company's requirements to create concise, uniform policies.

       Procedures and Work Instructions

Procedures, or sometimes referred to as process descriptions, and work instructions answer the questions: "What is done, who does it, where is it done, and when is it done?" A procedure is a series of interrelated steps that are taken to help implement a policy. Procedures should contain: 

  References (including policy statements, memos, and delegation of authority)
  Process example (how the task may successfully completed)
  Resources (material, human) available for assistance
  Sample of properly completed forms, if appropriate
  Statement of specifically required steps or authorizations
  Definition of tasks to be accomplished


VATechWrite has extensive experience generating procedures and work instruction, both for hardware and software systems. 

  

 


Last Modified 06/29/2010

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