Spreadsheet Validation

Data Integrity App   Spreadsheet Inventory Review Inventory should be reviewed with the goal of minimizing the workload and simplifying the inventory. Often the spreadsheet inventory will include ‘populated’ spreadsheets (i.e. “.XLS” files) containing data and it is strongly recommended that these are NOT subjected to validation in their native format. In order to facilitate validation, it is preferable to install controlled and ‘empty’ spreadsheet templates (i.e. “.XLT” files); hence some reformatting / data cleaning will be necessary prior to validation. This reformatting step is an opportunity to review and rationalize the spreadsheets that are going to be subject to validation. An inventory review should be performed with the following questions in mind: • Are there any new requirements for existing spreadsheets? • Can any spreadsheets be combined to produce a single template? • Can spreadsheets be ‘genericised’ to allow future flexibility? The combination/gen...

Data Integrity App     Resources for spreadsheet Validation Many spreadsheet projects fail due to a lack of communication between the spreadsheet users and the people responsible for validation of the spreadsheets. It cannot be over emphasized how important it is to get full and complete buy in from the spreadsheet users. The key reasons for this are detailed below. • Often the spreadsheet users were the developers of the spreadsheet, and they have both intimate knowledge, and a sense of ownership of their creation. • The users know where and how the spreadsheets can be improved, and exactly where the deficiencies lie between the spreadsheet and the business process being undertaken. • The users are the people who defined the User Requirements, and an error when defining the requirements cascades throughout the lifecycle to result in a spreadsheet that may not be fit for purpose. The user/owners invariably have the highest burden to bear during a spreadsheet vali...

Data Integrity App   Project/Validation Preparation Project planning is essential for the successful execution of any validation exercise. This is particularly true when embarking on spreadsheet validation. It is likely that a large number of spreadsheets will be involved and therefore efficiency and repeatability are critical factors in the validation process; the key to the efficiency and minimizing the validation costs is to keep the process simple. This is achieved by introducing streamlined processes throughout the validation lifecycle, and the use of a generic yet adaptable set of documentation. It is essential that the validation process is documented and commonly this may require a formal Validation Plan to satisfy local procedures. Alternatively it may be possible to document your process in other project documents such as Standard Operating Procedures (SOP) or the Spreadsheet Specification. However, one of the biggest strengths of a Validation Plan (and s...

Data Integrity App Tips & Tricks for spreadsheet Validation   A good road map and some tips and tricks can help you on your way through the rough landscape of spreadsheet validation. With all your experience, regulations, and guidelines in mind, develop a spreadsheet that includes all necessary requirements. Think of the following aspects: Use of the spreadsheet must be restricted to the intended user. Place the template on a (server) location with access limited to selected users. Protect the spreadsheet with a password that allows users to open the spreadsheet as read-only. You want to protect the spreadsheet against any undesired changes, so lock all cells within the spreadsheet (except the cells in which the user needs to give input). This way, the user cannot change cells with formulas, constants, labels etc. Give the input cells a color to make the spreadsheet more clear and easier to understand fo...

Data Integrity App   Does the spreadsheet need to be validated? One of the first things that need to be determined is whether or not the spreadsheet needs validating. These principal questions should address whether the spreadsheet is used to support an activity governed by any applicable regulation, typically GMP’s1,2, GLP’s3,4, ERES5, Medical Devices6 etc. If the answer is Yes, then the simple answer is that it should be validated.   “Trust but Verify “  Ronald Reagan   Across the internet, there are millions of resources are available which provide information about Everything.   If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity. Data Integrity App   Our Data integrity  app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry. ...

Data Integrity App How to Implement Data Integrity Controls for Spreadsheets To meet data integrity spreadsheets companies, need to know the population of these electronic tools in their environment.  Once an inventory is created the next step is to understand the spreadsheets GMP, Part11, and risk level impact. To understand the impact of spreadsheets companies, need to develop assessment and related procedures that ensure an objective and accurate assessment. The assessment should include the following: ·           GxP Impact Assessment ·          Part 11 Assessment  ·          Risk Level Assessment These assessment are an input to the URS document and validation strategy. The URS document must include specific data integrity requirements that must be validated. Unfortunately, spreadsheet lack data integrity technical controls out of the box. To meet data i...

Data Integrity App   How to Identify Spreadsheets That Must Meet Data Integrity Requirements One of the biggest challenges normally faced by the industry is not knowing the population of spreadsheets at their facilities. Normally lack an accurate inventory of spreadsheet that may be used for GMP operations that must meet data integrity requirements. The lack of validation is another challenge for spreadsheets that are not identified as having GMP impact. Spreadsheets that are not validated lack procedure and technical controls that enable data integrity. Identifying spreadsheets that may have GMP impact is a critical activity to ensure compliance with data integrity and regulatory requirements. To identify spreadsheets that may have GMP impact companies need to initiate a remediation project for these electronic tools. A remediation plan should be created to define the activities, roles, responsibilities and overall strategy to identify, validate and enable data integrity f...