Tips on Writing Validation Documents

Writing clear and concise validation documents is a challenging task. It entails religiously adhering to standard formats and guidelines. May it be validation protocol, or a validation master plan, there are a few basic tips to follow that will help construct strong professional documents based on commonly found errors. 

1. Provide detailed Design Specifications.

Design Specifications should specifically point how the requirements will be met. It is one of the most technical of all the documents that is why it is critical that this should be written in a logical manner. It is advised to use a template to keep the Design Specifications detailed, functional, and streamlined.

2. Know how often the protocols will be performed.

The number of times the protocol is expected be used should dictate the time spent to write it. If the protocol will be used for numerous times, careful planning and writing should be done to make the protocol efficient and effective.

3. Keep grammar and style in check.

Blatant grammatical errors and wrong spellings can cause great difference in the execution of the protocol. The writing and tenses should be kept consistent throughout the paper so as to prevent confusion when using it.

4. Get to know who will use the protocol.

Consider the person who will use the protocol, if he/she is not familiar with the system, always write procedures that are easy to understand and with more detailed instructions.

5. Keep the requirements clear.

The requirements should be written in a concise and clear manner. It should be read as simple as possible without compromising the intended objectives.

6. Avoid long procedures

Ideally, the maximum length of a procedure is up to five (5) sentences. If the steps are lengthy, it is advised to cut them off to 2-3 smaller steps.