Validation Practices for the Pharmaceutical Industry

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Italvacuum, Srl

Donadon SDD Srl

Subsequently, the level of risk evaluated is mitigated based on the client’s requirements. The agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records and any corresponding requirement. The FDA recommends that one supplies copies of electronic records by:

• Producing copies of records held in common portable formats when records are maintained in these formats

• Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML OR SGML)

In each case, it is recommend that the copying process used produces copies that preserve the content and meaning of the record. The agency also intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable its accurate and ready retrieval throughout the records retention period and any corresponding requirement.

As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, the electronic version of the records can be deleted. In addition, paper and electronic record and signature components can co-exist (i.e., hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved.

Application and Benefits

The compliance to 21 CFR Part 11 offers multiple benefits. Cost benefits through aiding the production of systems that are fit for purpose, meeting user and business requirements, and having acceptable operation and maintenance costs. Better visibility of projects to ensure delivery on time, on budget and agreed quality standards is available. An increased understanding of the subject and introduction of a common language and terminology is also obtained.

There are reductions in the cost and time taken to achieve compliant systems. And an improved compliance with regulatory expectations by defining a common and comprehensive life cycle model is attained. Moreover, the clarification of the division of responsibility between user and supplier is realized.

Start-ups and shutdowns of Batch Process Control System (BPCS) and Safety Instrumented System (SIS) equipment are rare enough that even experienced Distribution Control System (DCS) support personnel need reminders of the most efficient method to minimize the downtime of the process units.

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