Hi,
I am new to computer system validation. Can anyone please help me with the Validation on Standalone systems? I mean how we perform validation on UV/VIs spectrometer?
Hi Arpita,
Normally validation applies to the processes and softwares but analytical instruments are qualified rather. It is called as AIQ in short.Analytical Instrument Qualification (AIQ) is documented evidence that an instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Use of a qualified instrument in analyses contributes to confidence in the veracity of generated data.
Software used for analytical work can be classified into following categories:
firmware
instrument control, data acquisition, and processing software
stand-alone software
Qualifying the instrument functions inturn qualifies the operations of a firmware because instruments cannot function without a properly operated firmware. You have mentioned standalone software in your question. Is that a standard LIMS to which your UV/VIs are interfaced? Please clarify for more precise answers.
Regards
shaamu
Hi Arpita
[justify]Your first task is to collate a list of all the equipment/software/items you are responsible for along with a list all your management’s requirements (GMPs/procurement/vendor audit/safety cases/SOPs/training/cleaning) into a concise and detailed plan of action - a Validation Plan (VP). In this plan you layout what you are going to do – what – when and with whom. Here you will document your companies approach to embedded and stand- alone software. What-ever you decide to do; must be documented here, this way all the agree actions/timelines/responsibilities you have decided upon are reviewed, agreed, adopted and approved by your company.
Then apply a properly targeted Validation Risk Assessment (VRA) to each system/software/item on your list. This VRA is a mandatory document which you must use to produce a documented justification for the depth and scope of validation you are proposing to apply to each item you propose to validate. This VRA should also be used to document whether the individual item being validated produces data that that must be controlled in accordance with 21 CFR Part 11. (This also is mandatory). This is what the regulators have offered to enable us to vary the intensity of our validation requirements and bring cost effectiveness to the whole validation arena.
The result of your VRA should identify equipment/items that; do not require validation; require minimal validation; require standard validation; require full life cycle validation. All items/equipment/software with a direct or indirect impact on a regulated product’s quality/efficacy/or predicated records will require some degree of validation.
With your VP and VRA in place you can then proceed to author your inspection and verification protocols – Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ). Where items quite basic and simple and do not require extensive documentation it is permissible to condense the IQ/OQ/PQ into one combined protocol document.[/justify)
Alex Kennedy
Quite elaborated answers on Validation, Thanks folks.
In my opinion, the approach of standalone system is thye choice of individual company policy based on the intended use and predicate rules. If the approach decides to be validated…adopt the basic concepts…Change control or installation approval procedures, URS, DQ, IQ, OQ and finally PQ. Contents of these documents may vary but the zist of document will remain same i.e. Avaliable feature validation, intended use result consistancy etc…