ability supervision Software for Gmp indispensable Electronic Records

Employment - ability supervision Software for Gmp indispensable Electronic Records

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Traditionally, records that are required for compliancy with Glp, Gcp and Gmp or that will be submitted to regulatory authorities have been maintained on paper and, where required, authorized through the use of a hand-written signature on that paper.

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Employment

Modern self-operating systems allow us to achieve record-keeping functions through the use of computerized systems, which may replace the paper records entirely or in part.

In addition, it is inherent to add an electronic signature to those records that serves the same purpose, has the same meaning and the same legal point as a hand-written signature.

Since these records and signatures are needful to both compliancy and other firm needs, it is foremost that processes and controls exist to ensure their integrity, security, and approved confidentiality. The use of electronic records and signatures is voluntary and so it is still allowable to use hand-operated record-keeping systems and sign records on paper using primary controls, although this may in many cases be considered cumbersome and less cost-effective.

Wherever it is practicable, new systems that employ electronic records or signatures should not be implemented until full compliancy is achieved. It is recognized that where industrial off-the-shelf software is purchased, even where it is best available for purpose, it may still be some time before a fully compliant version is available.

In these situations the gap in the middle of the system as it stands and a state of compliancy must be analyzed and the related risks assessed. An operation plan, approved by local administration and reviewed or approved as approved by Qa, should be advanced to consist of any operating procedures or other stop-gap measures which can be employed to administrate the risks from non-compliance and the proposed steps to finally achieve compliance.

This should include, where feasible, notifying the vendor of shortcomings. Correspondence from the vendor with regard to hereafter upgrades should be retained. The system Owner must be fully aware of the firm and regulatory risks related with the implementation and use of a not inherently compliant system and be prepared to own and clarify those risks.

Any new system should consist of the relevant requirements defined by 21 Cfr Part 11 in its User Requirements Specification. These should consist of requirements on the supplier's amelioration standards and practices as well as on the product itself ie. Developer education, training and experience; controls over systems documentation.

Electronic records, regardless of whether they are signed, have the same point to the firm as their paper counterparts. As such, they are considered regulatory documents when used in retain of Gcp, Glp, or Gmp-governed operations or directly in regulatory submissions and should be treated as such. Regulated electronic records are widespread in amount and range and could consist of such things as case article forms, manufacturing batch records and laboratory records. However, even though data is initially collected and stored electronically, a printed copy of the article may still be considered the lawful article in case,granted that its integrity, accuracy and completeness can be assured and the electronic version is not used for any additional regulated activities.

Actual firm processes/practices are key to this determination and it is foremost that, where parallel records are held and the paper is deemed to be the regulated version, the rationale for this is recorded in a controlled document and steps are taken to ensure that the electronic version is not inadvertently used for a regulated purpose.

In any case, Glp and Gmp want that the raw and derived data be stored. Often a measuring gadget will work a host collecting/managing system. If only derived data is being stored on the host system, then a way must be found to store the raw data. If the gadget is not capable of uploading raw data to the host system or if there is no hard drive or other permanent storage, then a printout would be approved as raw data documentation. The practicality of this must be considered on a case-by-case basis and will vary depending upon the capabilities of each device.

Due to the intent of the definition of an electronic record, which focuses on a computer system's data/processed information, software is not branch to the same types of control.

However, system lifecycle system and change operate procedures apply to all computer systems including software that is used to automate hand-operated processes that have regulatory impact. Some examples of exact controls required are the maintenance of a software change history, validation and documentation of the system software, limitation of passage and the use of code administration tools and practices.

Any new system should consist of the relevant requirements defined by 21 Cfr Part 11 in its User Requirements Specification. These should consist of requirements on the supplier's amelioration standards and practices as well as on the product itself ie. Developer education, training and experience; controls over systems documentation.

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