Software validation Requirements


Few Important points.

Most important part now a days in any validation is access control

Minimum two level password protection and authorization. Recommended level is of four password.

Right and configuration of above can make the life easy or difficult for the Manager and company.

Check whether Audit trail or history for important event available or not? This can help tracing out the problem and find the root cause of any concern area. Very important for effective monitoring of CAPA.

This features can easily be configured in the system and PC can be used in place of MMI to store all data.

21 CFR part 11 Compliance test. Very important part and crucial for better management. Each and every point of 21 CFR part 11 compliance needs to be tested with evidence attached.

Business continuity and Disaster Management. How effectively you can be back into the business if circumstances arise to stop production forcefully damaging the equipment?

Partnership with your validation agency is very important. It is like tying a knot. The agency should be visiting the plant and checking all your change control related documentation for the Automation (Software – Hardware Modification). They will decide revalidation required or not? If required How Much? Better talented association will save lot of money for you.

Training to your staff about Validation is a must. Details about how to maintain the system in a qualified state all the time through it’s life cycle is also very important.

Detailed Risk assessment should be carried out and explained to the operator to manager level so that any unwarranted changes are eliminated.

The person validating the machine has to have experienced with the machine and should have completed say 50-100 PLC Validation in his job span than only you can relay on him for better validation. You are taking services from the expert. He should have that vision and inspection eye which is very vital.

As far as possible the validation work and report must be submitted by the team at site only (Better accuracy prevails and quick check in case of doubt will reduce mistakes).