Predisys Batch History Records

Many manufacturers, such as medical device manufacturers, are required to maintain documented evidence that the devices are manufactured in accordance with the production specifications, and that they meet their requirements and specifications. To achieve this, the FDA specifically requires the compilation of a collection of records called the Device History Records (DHR), which contain the production history of the finished and released products. The DHR provides both objective evidence that the devices were manufactured in accordance with the Device Master Records, and acts as a record of traceability information for all units or lots. While ISO 13485:2003 does not call for creating the DHR specifically, it does require the generation of the individual records contained within the DHR.  These records must be maintained for at minimum the design and expected lifespan of the device, and provide traceability of the devices. FDA and ISO regulated production documents and records also include the results of all acceptance activities performed during and after production, as well as records of any rework activities performed.

Predisys eBHR - Paperless Records Management

Managing paper based records is a major cost for most organizations. The Predisys solution abolishes paper and provides electronic records management with digital signatures and audit trails for reduced data entry and processing errors, faster information exchange, and cost savings resulting from less storage space. Electronic records management also ensures that the latest approved versions of production documents are instantly deployed to the plant floor, eliminating the risk outdated documents being in use. In addition, Predisys eBHR offers automated document approval and user access management, ensuring that no unapproved versions are distributed to the plant floor, or that unauthorized personnel have access to documents.

Predisys eBHR delivers a comprehensive and cost-effective FDA CFR 21 Part 11 compliant solution for manufacturers in regulated environments. The eBHR solution consists of intuitive, easy-to-use and customizable digital applications to guide the production process and record the production. The Predisys solution utilizes Microsoft Office and Microsoft SharePointtechnology, providing a familiar, recognizable and customizable user interface.

Predisys eBHR consists of interconnected digital applications which can be configured to suit any type of lot or batch based production. Predisys eBHR solution can be built to allow access to the data on a global basis, thus providing access to real-time production information anywhere, anytime.

The applications include templates for the following types of record:

  • Job Traveler
  • Inspection Data Collection Form
  • Product Specification Form
  • Checklist
  • Scrap Report
  • Production Run Sheet
  • Quality Inspection

These applications enable the recording of various types of production data:

  • Test results
  • Equipment traceability
  • Material traceability
  • Process and lot statuses
  • Acceptance decisions
  • Electronic signatures
  • Lot release

Each application contains a fully CFR 21 Part 11 compliant comprehensive Audit Trail.

The option to directly input data into Predisys eBHR with digital measuring devices eliminates the need for manual data entry. This prevents typing errors and other inaccuracies and simultaneously saves time.

With Predisys eBHR, DHR records are stored safely in backup systems and secure server environments. Compared with maintaining the data as paper-based records, this significantly reduces the risk of misplacement and even destruction and loss of the documents through fire, water-damage, or other accidents.