Automated Control Concepts, Inc. | 3535 Route 66, Neptune, NJ 07753 | p. 732-922-6611 | f. 732-922-9611 | e. info@automated-control.com

Automation Project
Management & Consulting

ACC provides automation-related services for project based as well as corporate or strategic activities. ACC works with each customer to determine the most appropriate structure for an engagement and develops a scope of work, with well-defined deliverables, schedule and lead resources. It is important that ACC’s roles and responsibilities are clearly understood so that the criteria for success are well defined prior to the start of work

ACC provides project-related services for all phases of project life cycle, and can function in a variety of capacities, depending on specific resources needs of the customer. From a conceptual design and specification development to system implementation and validation, ACC can provide technical leadership and automation project management. Additional resources for project implementation of defined automation deliverables can also be provided. ACC follows a system life cycle methodology for project-related services based on GAMP.

ACC can also serve in a general automation-consulting role, providing extensive expertise and experience in automation technology, pharmaceutical process and regulatory requirements, and experience in automation implementations. Typically, ACC serves in this capacity to a corporate or division technology group, providing guidance in setting automation strategy, assessing the existing technology infrastructure, or defining corporate or site automation standards.

Project-based Services

  • Automation/Information Technology Assessments – Evaluation of the existing systems within a predefined border (typically a facility or process area). The resulting deliverable is an assessment with recommendations on how to leverage existing investments through upgrades, additional components, or system interfaces.
  • Project Planning – Specific Automation Standards – Definition of specific automation standards to be followed throughout the project life cycle by all parties responsible for automation deliverables. Typically, standards are developed for software, document, and hardware deliverables. For example, software deliverables are governed by standards for data table layouts and code annotation. Document deliverables are governed by standards for document content, format, and layout.
  • Master Computer System Validation Plans – Definition of automation quality assurance plan for a project, including the overall strategy for system testing, the specific role of each phase of testing and test inter-dependencies (vendor factory tests, site testing, acceptance testing, validation), as well as procedures for configuration management and change control.
  • Automation Project Management – Review of project submittals by any parties responsible for automation deliverables, monitoring project budget and schedule.
  • Detailed Design – ACC may provide services from guidance and oversight to actual development of detailed design documents. Typical deliverables include detailed functional specifications, hardware and software design specifications.
  • Implementation – ACC may provide assistance for the implementation of a portion or all automation-related deliverables.
  • Vendor Coordination – ACC may coordinate with equipment manufacturers providing local controls for a specific machine or skid.
  • Validation – ACC can develop and execute validation protocols (IQ, OQ, PQ).

General Automation Consulting

  • Automation/Information Technology Assessments – Evaluation of the existing systems within a predefined border (typically a facility or process area). The resulting deliverable is an assessment with recommendations on how to leverage existing investments through upgrades, additional components, or system interfaces.
  • Compliance Assessments – Determination of whether existing systems meet corporate (i.e., validation) and regulatory requirements such as 21 CFR Part 11. Typically the first deliverable is a Compliance Checklist, approved by the customer’s compliance officer. Following agreement on this document, each system is evaluated against it, and a Compliance Assessment including remediation recommendations is developed.
  • Definition of Corporate Automation Standards – Development of corporate standards for automation implementation, with the goal of common project life cycle, and commonality of software, hardware, and document deliverables. The development of such standards streamlines project execution, as requirements are clearly communicated, and documents and software become more easily re-usable.
  • Definition of Pilot/Rollout Plans – Concepts or system components being implemented for the first time with a future planned rollout face a unique challenges. In these situations, it is important that success criteria are established prior to system deployment, and that a specific rollout plan is devised.