S88 Batch and 21 CFR Part 11

S88, also known as ANSI/ISA-88, is a standard adopted by The International Society of Automation (ISA) addressing batch process control. 21 CFR Part 11 is a United States Food and Drug  Administration’s (FDA) guideline on electronic records and electronic signatures.

Optimation provides engineering services for S88 and 21 CFR Part 11 implementations. Our engineers specializing in batch process and control systems have experience with S88 and 21 CFR Part 11 the standard dating back to their inception/approval. We have implemented it on a wide variety of DCS and PLC platforms. Our engineer’s full range of project services expands across several industries including chemical, food and beverage and life sciences/pharmaceuticals.

Benefits of Implementing S88

  • Recipe Based
  • Scheduling and Efficiency
  • Batch Control
  • Material Management
  • Reporting and History

The key to success in an S88 system is defining the phases as building blocks that can be easily re-positioned in the recipe. It requires a thought process of how the recipe maker is likely to want to modify the batches. With this framework it is easy to have production staff create the recipe and not operations staff. The operations team is empowered to provide efficient execution and tracking their implementation.

How can Optimation's S88 Implementation services benefit you?

  • Increases system flexibility and productivity
  • Better identification of your system requirements
  • Reduced cost to automate a batch process
  • Faster time-to-market
  • ROI increases with each subsequent project

21 CFR Part 11 Implementation is a Requirement

21 CFR Part 11 specifically requires pharmaceutical, medical device manufacturers and other FDA regulated industries details/exceptions to implement audits, system validations, audit trails, electronic signatures and documentation for systems processing electronic data.

Benefits of 21 CFR Part 11

The benefits of electronic records and signatures are very significant for our clients operating within a regulated industry, they include:

  • Increased availability of data integration, trending information and historical data
  • Improves product quality and consistency
  • Increase the speed of data sharing
  • Advances searching capabilities
  • Reduces susceptibility of signature fraud and report misfiling
  • Reduces cost related to record keeping and storage

We can help you become 21 CFR Part 11 Compliance

Our engineers specializing in batch process and control have several years experience with 21 CFR Part 11 implementation including:

  • Engineering assessments -  we can determine where you are and set a path toward regulatory compliance
  • Development of SOP to support electronic batch records and electronic signatures
  • Audit Trail Reports including
    • Linked electronic batch records to electronic signatures
    • Implementation of windows security including account polices and user login
  • Automated Validation Documentation Templates
    • System Traceability from concept to completion
    • GAMP5 compliant documentation
  • Validated system with supporting validation documentation

S88 Defines:

  • Batch Process
  • A process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time using one or more pieces of equipment

  • Batch Control

    Control activities and functions that direct batch processes

21 CFR Part 11 Defines:

  • Electronic Records
  • Means any combination of test, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

  • Electronic Signatures
  • Means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.