During the course of a project set up meeting with one of our long established customers, the chain of conversation went down an interesting route. The customer had mentioned that a number of years previously, they had installed a new clean room in an extension of the facility.
Under the terms of the contract with the supplier of the clean room, the validation activities and all supporting documentation were to be provided and written by the suppliers’ own in house validation team.
Naturally, this set alarm bells ringing – if they were bringing this up, then there must have been a problem. Sure enough, in preparation for a regulatory audit, serious errors were discovered during the course of document checking and reviewing. The supplier had made no references to a number of different SOP’s and had even included the wrong customer name!
This raised some serious questions about the level of responsibility that in house teams must shoulder when managing and reviewing new documents, and the importance of peer reviewing every relevant document. More importantly, it shows the importance of using an independent party to validate any new equipment.
Here are some of the reasons why independent validation is a necessary activity:
- The validation partner will be completely independent and offer an unbiased assessment of all work carried out. Sometimes, this will not be the case for any in-house or supplier project teams.
- You can guarantee that the independent partner will not take any shortcuts on testing methods, writing documents etc because ultimately, their professional reputation is on the line.
- While engaging the services of an independent partner is an additional short term cost, it means you will avoid much larger long term costs if any remediation plan needs to be implemented because of errors made.
- An independent validation consultant can also offer advice and consultation because of their experience in dealing with different organizations and systems. This could allow any in house team to think about a project in a more efficient and cost effective light, ultimately which is reflected in the bottom line.
So, to summarise, the message is pretty clear; don’t learn the hard way, use independent services from the outset.