Effective life science project management documentation practices play a vital role in driving efficiencies and maintaining compliance requirements throughout any life science project. However, the process can quickly become unwieldy.
When faced with revising three to five hundred documents during the course of a single project, it's easy to get overwhelmed. You may ask, “Where do I even start?” or “How do I prioritize all this work?” You may begin to doubt if the project milestones in front of you are truly achievable.
Enterey’s team of experienced life science consultants specializes in managing life science project management documentation updates as part of our strategic planning and process improvement solutions. When faced with documentation challenges, we have found success in defining and sticking to four specific best practices to align resources and keep work moving forward to completion.
One Source of Truth
It’s not uncommon for each stakeholder group to want to track their own documents when managing change across a complex project. Avoid the temptation to have multiple trackers and different sources of truth. Having one source of truth helps to:
- Prevent miscommunication among stakeholders
- Provide real-time data on the types and progress of document revisions
- Deliver a bigger picture on patterns and trends that will help make key decisions with documents
- Identify common issues or roadblocks for a particular set of documents
Using a tool that allows you to manage a large set of data across multiple stakeholders, while keeping track of changes, will help you keep your sanity as you execute the project.
There’s Power in Groups!
During document identification and assessment, group and categorize documents as much as possible. Grouping documents helps make revisions more manageable than navigating through each document individually. Once groups have been identified, they can follow different defined plans of attack and be prioritized by risk vs. impact.
Some ideas to consider when grouping documents are:
- Training vs. no training. Do certain documents require training?
- Type of revision. Do documents need to be created, revised, or obsoleted?
- Similar content. Are there any documents that will have similar revisions necessary? For example, there are five SOPs regarding instrument maintenance that will have very similar updates.
- Level of effort. Are these documents going to be simple updates or more technical updates that will require additional discussion from subject matter experts?
- Functional area. Are these documents all owned by the same functional area or different functional area?
Thinking Outside the Box
Developing alternative, innovative solutions begins with a thorough understanding of your company’s Document Management System (DMS) and its document approval process. It’s okay to learn more about the document approval process as you go, or you can collaborate with someone there who knows the document approval process really well. Knowing the existing available technology and functionality can open new alternative ways to save time and money. Some items to consider include:
- Is there any opportunity to expedite document approval? Do all documents need to go through a full approval process?
- What are the different functional area’s roles in the DMS? How will your document revisions affect others’ (i.e. approvers) internal processes? Can they modify their processes, even temporarily, for this project for low-risk approvals?
- Do you know what each approver looks for? Can they modify their requirements for this revision effort?
- Do any documents have dependencies? Can the documents be revised independently instead?
There’s No “I” in Team
The old adage, “There’s no ‘I’ in team” rings just as true with document revisions. One of easiest (and simultaneously hardest) things to manage with document revisions is not the revising of the document content itself, but the communication and teamwork involved with the people. Document revisions are a teamwork activity. It involves one or more document editors, document reviewers, and document approvers from different functional areas. Therefore, the level of constant communication and teamwork can determine how successful the document revisions will be. Some items to consider include:
- Do all stakeholders know their roles and responsibilities clearly? This includes both internal and external stakeholders.
- Are all stakeholders aware of this effort? Do they know the objectives and timelines for these documents? This can be accomplished with a kickoff meeting.
- Do the stakeholders know when, what, and how to expect communication from the project team?
- Is everyone on the same page? Are managers communicating down?
- Who will be the delegate for functional representatives on the team? This ensures that work will not be halted if someone is out of the office and/or unavailable.
- If something goes wrong, is there a process to communicate that? Do they know when and how to communicate that, and to whom?
Are you optimizing efficiencies and compliance with your documentation management strategic planning processes? Use Enterey's free Portfolio Project Management assessment tool to analyze your PPM efficiencies. Or, schedule a meeting with Enterey’s Life Science consulting team today to learn more about streamlining output and results across your operational models.
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