\nEven for biopharmas with strong processes and a quality mindset,
\nvalidation can be fraught with risk and inefficiency. Scope creep can
\nhappen when teams don\u2019t establish clear expectations at the beginning
\nof a new project. Testing and documentation can become cumbersome,
\ntrapping teams in an endless cycle of validation that stifles new
\nfeatures and innovation.\n<\/p>\n
\nThe IT team at Endo Pharmaceuticals Inc. (Endo) knows this firsthand. After their
\nfirst ³Ô¹Ï±¬ÁÏ implementation, Gregory Rosen, executive director
\nof IT, and Joanna Ollendorff, associate director, computer systems
\nvalidation, saw an opportunity to make the validation process simpler
\nand more efficient.\n<\/p>\n
\n\u201cWe tested everything. Like many other companies, we didn\u2019t have an expert understanding of the system and
\nwe were duplicating efforts that ³Ô¹Ï±¬ÁÏ had already done,\u201d said Ollendorff. \u201cWe didn\u2019t identify what was Endo-specific configuration and what was base functionality from ³Ô¹Ï±¬ÁÏ.\u201d\n<\/p>\n
\nRosen described the level of effort at that time as immense and unsustainable. \u201cEvery time we had a release,
\nwe\u2019d have to go through an exhaustive exercise to ensure that the release maintained our defined validated state
\nof the application. Which essentially meant we would never be able to take advantage of the new features ³Ô¹Ï±¬ÁÏ
\nwas introducing.\u201d\n<\/p>\n
\nThe team was determined to make a change.\n<\/p>\n
\nAt its core, Ollendorff describes Endo\u2019s strategy as a risk-based approach to validation modeled on
\nGAMP 5. But, some simple changes in mindset have reduced the impact on IT resources and the
\nbusiness as a whole. Endo\u2019s strategy centers on leveraging the validation work that ³Ô¹Ï±¬ÁÏ already does to
\nreduce the overall testing burden and speed the adoption of new capabilities.<\/p>\n
\nA thorough quality assessment of the vendor is the first \u2013 and perhaps most critical \u2013 step in the validation
\nprocess. Defining expectations up front and leveraging ³Ô¹Ï±¬ÁÏ\u2019s documentation helps Endo reduce time
\nspent and get to value more quickly.\n<\/p>\n
\nEndo accomplishes this by using ³Ô¹Ï±¬ÁÏ\u2019s classified levels of validation risk as a guidepost for running test
\nscripts during implementation. For out-of-the-box or low-risk functionality, no testing may be required at all.
\nWhen testing is necessary, the Endo team works closely with the ³Ô¹Ï±¬ÁÏ team to execute the test scripts in a
\nsandbox environment until they are approved. This methodology limits testing to only Endo-specific
\nconfigurations with a certain risk profile, eliminating redundancy and creating more value for the company.\n<\/p>\n
\n\u201cWe are not duplicating efforts, we\u2019re not retesting what ³Ô¹Ï±¬ÁÏ has already tested,\u201d said Ollendorff. \u201cWe\u2019ve
\nmitigated the risk of doing that: we audited ³Ô¹Ï±¬ÁÏ\u2019s company and quality systems structure, we performed
\nan IT security assessment, we looked at ³Ô¹Ï±¬ÁÏ\u2019s CSV practices, and through those actions, we were able to
\nmitigate the risk down to an acceptable level for the business.\u201d\n<\/p>\n
\n\u201cIn the world of cloud-based GxP tools there has to be a comfort level that people get to, and it all starts with
\nthe vendor assessment,\u201d added Rosen. \u201cHaving the mindset to look at ³Ô¹Ï±¬ÁÏ as a GxP supplier has helped,
\nthat\u2019s the real advancement in our thinking.\u201d\n<\/p>\n
\nOnce implementation is complete, Endo adopted a similar mindset for managing updates: create efficiency
\nby leveraging what has already been tested. For ³Ô¹Ï±¬ÁÏ\u2019s major releases, which happen three times a year,
\nEndo takes a three-step approach:\n<\/p>\n
\nDuring this process, Endo reviews ³Ô¹Ï±¬ÁÏ\u2019s release impact assessment and compares it to its own
\nenvironment. While something in a general release might be a high risk for general use, if it\u2019s not a feature
\nEndo has in its configuration the team rates it as not applicable, or low impact. Doing so saves unnecessary
\ntesting and validation efforts, and is a key differentiator in Endo\u2019s overall approach.\n<\/p>\n
\n\u201cA lot of companies say they take a risk-based approach, but they end up testing everything, even if it\u2019s
\nlow-risk or has no impact,\u201d said Ollendorff. \u201cIt becomes very cumbersome if you\u2019re not relying on what ³Ô¹Ï±¬ÁÏ
\nhas already tested, and you could end up rerunning those scripts as part of regression testing every time
\nthere\u2019s an update.\u201d\n<\/p>\n
\nThe last piece of Endo\u2019s risk-based validation strategy is managing enhancement requests to existing
\nfunctionality, for example, turning a required field on or off, or something more involved, like adding new
\npieces of functionality.\n<\/p>\n
\nFor these changes, Endo uses a governance process that catalogs and categorizes every enhancement
\nrequest and assigns each one a score based on the expected level of effort and IT complexity. Low-effort
\nitems, like cosmetic changes, score one point, medium items such as changing a configuration setting
\n(already tested by ³Ô¹Ï±¬ÁÏ) score three, and high-effort items, for example, additions that necessitate a test
\nscript, score seven points. For each bundled release, the Endo team ensures that the total score of requested
\nenhancements does not exceed 13 points. By using this methodology, Endo can cap the impact on the
\nvalidation process and manage updates more effectively.\n<\/p>\n
\nDuring this phase, the Endo team continues to rely on ³Ô¹Ï±¬ÁÏ\u2019s documentation to assess whether a
\nnew feature or functionality truly needs to be tested or can simply be verified with existing documentation.
\n\u201cWe are a lean team,\u201d said Rosen. \u201cWe don\u2019t have a huge department, so we need to work smarter.
\nThis approach helps us compartmentalize the impact and still be compliant.\u201d\n<\/p>\n
\nWith this three-step strategy in place, Endo has been able to achieve gains in both speed and efficiency
\n\u201cHaving a risk-based approach to validation enabled us to launch three additional Vault products in six months.
\nBenchmarking revealed that for many companies the same effort would take 36 months, with one of the biggest
\nfactors being the validation efforts,\u201d said Rosen.\n<\/p>\n
\nOllendorff credits a lot of the improvement to how the team changed their mindset from a traditional, on-premise,
\ntest-everything mentality, to embracing a risk-based approach and leveraging the partnership with ³Ô¹Ï±¬ÁÏ. \u201cAll of
\nour requirements are being met, it\u2019s just being done in a different way.\u201d said Ollendorff.\n<\/p>\n
\nFor Endo, reducing the impact of the validation processes has yielded clear benefits to the business. \u201cWe\u2019re still
\nmaintaining a high compliance profile and have achieved a significant level of bandwidth giving us the ability to
\nexplore, adopt, and introduce the new capabilities that ³Ô¹Ï±¬ÁÏ is providing without being in a constant state of
\nvalidation,\u201d said Rosen.\n<\/p>\n